Document text
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 1
3.2.P.5.4. BATCH ANA LYSES ................................ ................................ ................................ 3
LIST OF TABLES
Table 3.2.P.5.4-1. Summary of BNT162b2 Drug Product Lots ................................ ............... 4
Table 3.2.P.5.4-2. Batch Anal yses for Nonclinical Toxicology BNT162b2 Drug
Product L ot ................................ ................................ ............................... 14
Table 3.2.P.5.4 -3.Batch Anal yses for Nonclinical and Clinical BNT162b2 Drug
Product L ots................................ ................................ .............................. 15
Table 3.2.P.5.4 -4.Batch Anal yses for Clinical BNT162b2 Drug Product L ots.................... 17
Table 3.2.P.5.4-5. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 19
Table 3.2.P.5.4-6. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 21
Table 3.2.P.5.4-7. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 23
Table 3.2.P.5.4-8. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 25
Table 3.2.P.5.4-9. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 27
Table 3.2.P.5.4-10. Batch Anal yses for Network Process Performance Qualification
BNT162b2 Drug Product L ots................................ ................................ ..29
Table 3.2.P.5.4-11. Batch Anal yses for Pfizer Puurs L NP and Pfizer Puurs Fill/Finish
Process Performance Qualification BNT162b2 Drug Product Lots......... 31
Table 3.2.P.5.4-12. Batch Anal yses for Polymun Scientific LNP and Pfizer Puurs
Fill/Finish Process Performance Qualification BNT16 2b2 Drug
Product L ots................................ ................................ .............................. 34
Table 3.2.P.5.4-13. Batch Anal yses for Pfizer Kalamazoo LNP and Pfizer Kalamazoo
Fill/Finish Process Performance Qualification BNT162b2 Drug
Product L ots................................ ................................ .............................. 36
Table 3.2.P.5.4-14. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 39
Table 3.2.P.5.4-15. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 41
Table 3.2.P.5.4-16. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 43
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
FDA-CBER-2021-5683-1149047
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 2Table 3.2.P.5.4-17. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 45
Table 3.2.P.5.4-18. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 47
Table 3.2.P.5.4-19. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 49
Table 3.2.P.5.4-20. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 51
Table 3.2.P.5.4-21. Batch Anal yses for Emergency Supply BNT162b2 Drug Product
Lots ................................ ................................ ................................ ........... 53
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
FDA-CBER-2021-5683-1149048
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 33.2.P.5.4. BATCH ANALYSES
BNT162b2 drug product lots used for nonclinical toxicology studies, clinical trials, process
performance qualification (PPQ), emergency supply , and stability are summarized in
Table 3.2.P.5.4-1 . A global approach to development has been undertaken across multiple
manufacturing facilities in order to maximize vaccine production and availability . As such,
information presented within the 3.2. P.5.4Batch Analy sessection reflects the global
development effort and the dru g product lots included are not limited to those produced in
market -specific registered manufacturing facilities. The lotanalyses data for BNT162b 2drug
product lots are listed in Table 3.2.P.5.4-2 through Table 3.2.P.5.4-21. A full drug product
genealogy can be found in Section 3.2.P.2.3 Lot Genealogy .The anal ytical testing strategy
applied to BNT162b2 drug product has evolved throughout the development history .
Information on the drug product method evolution/testing strategy is provided in
Section 3.2. P.2.3Analy tical Method Evolution . All results metthe acceptance criteria at the
time of release .The lots listed have been used in clinical studies and toxicology studies as
indicated.
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
FDA-CBER-2021-5683-1149049
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 4Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
COVVAC/270320 27-MAR -
2020Polymun
ScientificPolymun
ScientificNonclinical
toxicology, StabilityTable 3.2.P.5.4 -2
BCV40420 -A 30-APR -2020 Polymun
ScientificPolymun
ScientificClinical, Stability Table 3.2.P.5.4 -3
BCV40620 -A 24-JUN-2020 Polymun
ScientificPolymun
ScientificClinical, Stability Table 3.2.P.5.4 -3
BCV40620 -B 25-JUN-2020 Polymun
ScientificPolymun
ScientificClinical Table 3.2.P.5.4 -3
BCV40620 -C 26-JUN-2020 Polymun
ScientificPolymun
ScientificClinical Table 3.2.P.5.4 -3
BCV40620 -D 29-JUN-2020 Polymun
ScientificPolymun
ScientificClinical Table 3.2.P.5.4 -3
BCV40620 -E 30-JUN-2020 Polymun
ScientificPolymun
ScientificNonclinical, Stability Table 3.2.P.5.4 -3
BCV40720 -A 23-JUL-2020 Polymun
ScientificPolymun
ScientificClinical, Stability Table 3.2.P.5.4 -4
BCV40720 -B 24-JUL-2020 Polymun
ScientificPolymun
ScientificClinical Table 3.2.P.5.4 -4
BCV40720 -C 25-JUL-2020 Polymun
ScientificPolymun
ScientificClinical, Stability Table 3.2.P.5.4 -4
ED3938a16-JUL-2020 Polymun
Scientific Pfizer PuursClinical, Stability Table 3.2.P.5.4 -4
EE3813b29-JUL-2020 Polymun
ScientificPfizer Puurs Clinical, Stability Table 3.2.P.5.4 -4
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149050
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 5Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EE8492 05-AUG -
2020Polymun
Scient ific Pfizer Puurs Emergency supply,
StabilityTable 3.2.P.5.4 -5
EE8493 05-AUG -
2020Polymun
Scientific Pfizer Puurs Emergency supply,
Clinical, StabilityTable 3.2.P.5.4 -5
EJ0553 25-SEP-2020 Polymun
ScientificPfizer Puurs Emergency supply,
Clinical, StabilityTable 3.2.P.5.4 -5
EJ0724 29-SEP-2020 mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -5
EJ1685 05-OCT -2020 Polymun
Scientific Pfizer Puurs Emergency supply,
Clinical inventory,
StabilityTable 3.2.P.5.4 -5
EJ1686 07-OCT -2020 Polymun
ScientificPfizer Puurs Emergency supply,
Clinical inventory,
Stability Table 3.2.P.5.4 -5
EH9899 08-OCT -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply,
StabilityTable 3.2.P.5.4 -8
EJ1688 12-OCT -2020 mibe Pfizer Puurs Emergency supply,
StabilityTable 3.2.P.5.4 -6
EK4175 12-OCT -2020 mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -6
EK1768 16-OCT -2020 Polymun
ScientificPfizer Puurs Emergency supply,
Clinical inventory,
StabilityTable 3.2.P.5.4 -6
EK4176 16-OCT -2020 Polymun
ScientificPfizer Puurs Emergency supply Table 3.2.P.5.4 -8
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149051
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 6Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EK5730 23-OCT -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -8
EL0140 29-OCT -2020 mibe Pfizer Puu rs Emergency supply Table 3.2.P.5.4 -6
EL0141 29-OCT -2020 Polymun
ScientificPfizer Puurs Emergency supply Table 3.2.P.5.4 -6
EL0142 29-OCT -2020 mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -7
EL0725 30-OCT -2020 Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -8
EL0739 03-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -9
EK9231 04-NOV -
2020Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -9
EL1484 04-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -9
EK4237 05-NOV -
2020mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -7
EK4243 05-NOV -
2020mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -7
EK4244 05-NOV -
2020mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -7
EL1283 11-NOV -
2020Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -9
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149052
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 7Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EJ6795 12-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -14
EK4241 12-NOV -
2020Polymun
ScientificPfizer Puurs Emergency supply Table 3.2.P.5.4 -7
EK4245 12-NOV -
2020mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -14
EJ6796 13-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -14
EJ6797 17-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -14
EK4238 17-NOV -
2020Polymun
ScientificPfizer Puurs Emergency supply Table 3.2.P.5.4 -14
EK4240 17-NOV -
2020mibe Pfizer Puurs Emergency su pply Table 3.2.P.5.4 -14
EK4242 17-NOV -
2020mibe Pfizer Puurs Emergency supply,
Process performance
qualification , StabilityTable 3.2.P.5.4 -10
EL1284 17-NOV -
2020Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -9
EL7834 17-NOV -
2020Polymun
Scientif icPfizer Puurs Emergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -10
EL1491 18-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply,
Clinical, Process
performance
qualification, StabilityTable 3.2.P.5.4 -10
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149053
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 8Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EL3246 20-NOV -
2020Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -15
EJ3002 24-NOV -
2020Polymun
ScientificPfizer Puurs Emergency supply Table 3.2.P.5.4 -15
EL0200 24-NOV -
2020mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -15
EL0203 24-NOV -
2020mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -15
EM0477 24-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -16
EL3248 25-NOV -
2020Pfizer
KalamazooPfizer
KalamazooEmergency supply,
Clinical, Process
performance
qualification, StabilityTable 3.2.P.5.4 -10
EJ6134 26-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -16
EJ6136 27-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -16
EJ6788 30-NOV -
2020Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -16
EL1404 01-DEC -2020 mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -16
EL3249 02-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply,
Clinical, Process
performance
qualification, StabilityTable 3.2.P.5.4 -10
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149054
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 9Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EK9788 03-DEC -2020 Pfizer Puurs Pfizer Puurs Emergency supp ly Table 3.2.P.5.4 -17
EL1406 03-DEC -2020 mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -17
EN3924 03-DEC -2020 mibe Pfizer Puurs Emergency supply Table 3.2.P.5.4 -17
EL3247 05-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -17
EJ6789 07-DEC -2020 Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -17
EL3302 07-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -18
EL8982 09-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -18
EJ6790 10-DEC -2020 Pfizer P uurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -18
EL8723 11-DEC -2020 Pfizer Puurs Pfizer Puurs Emergency supply,
Clinical, Process
performance
qualification, StabilityTable 3.2.P.5.4 -11
EM6950 11-DEC -2020 Pfizer Puurs Pfizer Puurs Emergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -11
EL9261 12-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -18
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149055
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 10Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EL9262 15-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -18
EN1185 16-DEC -2020 Polymun
ScientificPfizer Puurs Emergency supply Table 3.2.P.5.4 -19
EL9263 17-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -19
EN9581 17-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -19
EN5318 19-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -19
EL9266 21-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -13
EL9265 22-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -19
EL8713 23-DEC -2020 Pfizer Puurs Pfizer Puurs Emergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -11
EP2163 23-DEC -2020 Pfizer Puurs Pfizer Puurs Emergency supply,
Process performance
qualificationTable 3.2.P.5.4 -11
EP2166 23-DEC -2020 Pfizer P uurs Pfizer Puurs Emergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -11
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149056
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 11Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EL9267 29-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -13
EL9269 30-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -20
EL9264 31-DEC -2020 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -20
EM9809 01-JAN-2021 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -20
EM9810 04-JAN-2021 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -20
EP6775 04-JAN-2021 Pfizer Puurs Pfizer Puurs Emergency supply,
Process performance
qualificationTable 3.2.P.5.4 -11
EN6200 05-JAN-2021 Pfizer
KalamazooPfizer
KalamazooEmergency supply,
Process performance
qualificationTable 3.2.P.5.4 -13
EN6201 07-JAN-2021 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -21
EN1195 08-JAN-2021 mibe Pfizer Puurs Emergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -12
EP6017 11-JAN-2021 Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -21
EP9598 12-JAN-2021 Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -21
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149057
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 12Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EN6198 13-JAN-2021 Pfizer
KalamazooPfizer
KalamazooEmergency supply,
Process performance
qualificationTable 3.2.P.5.4 -13
EP9605 13-JAN-2021 Pfizer P uurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -21
EN1196 18-JAN-2021 mibe Pfizer Puurs Emergency supply,
Process performance
qualificationTable 3.2.P.5.4 -12
EN6199 19-JAN-2021 Pfizer
KalamazooPfizer
KalamazooEmergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -13
ER1741 13-JAN-2021 Pfizer Puurs Pfizer Puurs Emergency supply Table 3.2.P.5.4 -21
EM4965 20-JAN-2021 Polymun
ScientificPfizer Puurs Emergency supply,
Process performance
qualification, StabilityTable 3.2.P.5.4 -12
ET0384 28-JAN-2021 Polymun
ScientificPfizer Puurs Emergency supply,
Process performance
qualificationTable 3.2.P.5.4 -12
EP6955 30-JAN-2021 Pfizer
KalamazooPfizer
KalamazooEmergency supply Table 3.2.P.5.4 -21
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149058
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 13Table 3.2.P.5.4 -1.Summary of BNT162b2 Drug Product Lots
DP Lot Number Date of
ManufactureLipid
Nanoparticle
Manufacturing
SiteDrug Product
Fill and Finish
SiteLot Size
(Number of
Vials)Drug
Substance
Batch(es) Purpose of Material Data Location
EW6126 19-FEB-2021 Pfizer Puurs Pfizer PuursEmergency supply,
Process performance
qualificationTable 3.2.P.5.4 -11
a.This lot number is equivalent to BCV40720 -P.
b.This lot number is equivalent to BCV40820 -P.
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149059
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 14Table 3.2.P.5.4 -2.Batch Analyses for Nonclinical Toxicology BNT162b2 Drug Product Lot
Quality
AttributeAnalytical Procedure Acceptance CriteriaaLot Number
COVVAC/270320
Results
Appearance Appearance (Visual) Report result White to off -white suspension
pH Report result
Osmolality Osmometry Report result, mOsmol/kg
LNP size Dynamic light scattering
(DLS)Report result, nm
LNP polydispersity Dynamic light scattering
(DLS)Report result
RNA
encapsulationFluorescence assay Report result, %
RNA content Fluorescence assay Report result, µg/mL
ALC -0315 content HPLC -CAD Report result, mg/mL
ALC -0159 content HPLC -CAD Report result, mg/mL
DSPC content HPLC -CAD Report result, mg/mL
Cholesterol content HPLC -CAD Report result, mg/mL
Identity of encoded
RNA sequenceCapillary gel
electrophoresisReport result Retention times conforms to reference
RNA integrity Capillary gel
electrophoresisReport result, %
Bacterial endotoxin Endotoxin (LAL) Report result, EU/mL
Bioburden Bioburden Report result, CFU/
a. The information provided in this table represents the acceptance criteria used at the time of lot release.
Abbreviations: CAD = Charged aerosol detection; CFU = Colony forming unit; EU = Endo toxin unit; HPLC = High performance liquid chromatography; LAL = Limulus
amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription polymerase chain reaction
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149060
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 15Table 3.2.P.5.4 -3.Batch Analyses for Nonclinical and Clinical BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
BCV40420 -A BCV40620 -A BCV40620 -B BCV40620 -C BCV40620 -D BCV40620 -E
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)Free from
observable
particlesFree from
observable
particlesFree from
observable
particlesFree from
observable
particlesFree from
observable
particlesFree from
observable
particlesFree from
observable
particles
Subvisible
particlesSubvisible
particulate
matter
pH 7.4 ± 0.5
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD Report result,
mg/mL
ALC -0159
contentHPLC -CAD Report result,
mg/mL
DSPC content HPLC -CAD Report result,
mg/mL
Cholesterol
contentHPLC -CAD Report result,
mg/mL
Lipid identities HPLC -CAD Retention times
consistent with
referencesConforms to
referenceConforms to
referenceConforms to
referenceConforms to
referenceConforms to
referenceConforms to
reference
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)
(4)
FDA-CBER-2021-5683-1149061
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 16Table 3.2.P.5.4 -3.Batch Analyses for Nonclinical and Clinical BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
BCV40420 -A BCV40620 -A BCV40620 -B BCV40620 -C BCV40620 -D BCV40620 -E
Results
Identity of
encoded RNA
sequenceCapillary gel
electrophoresisMigration time of
the RNA
conforms to the
migration time of
the reference
RNAConforms to
referenceConforms to
referenceConforms to
referenceConforms to
referenceConforms to
referenceConforms to
reference
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility Sterile Sterile Sterile Sterile Sterile Sterile Sterile
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit;; HPLC = High performance liquid chromatography; LAL = Limulus amebocyte
lysate; LNP = Lipid nanoparticle;
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149062
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 17Table 3.2.P.5.4 -4.Batch Analyses for Clinical BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
BCV40720 -A BCV40720 -B BCV40720 -C ED3938 EE3813
Results
Appearance Appearance
(Visual)White to off -white
suspensionWhite to off-white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspension
Appearance
(visible
particulates)Appearance
(Particles)Free from
observable
particlesFree from
observable
particlesFree from
observable
particlesFree from
observable
particlesFree from
observable
particlesFree from
observable
particles
Subvisible
particlesSubvisible
particulate matter
pH 7.4 ± 0.5
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence assay
RNA content Fluorescence assay
ALC -0315 content HPLC -CAD Report result,
mg/mL
ALC -0159 content HPLC -CAD Report result,
mg/mL
DSPC content HPLC -CAD Report result,
mg/mL
Cholesterol
contentHPLC -CAD Report result,
mg/mL
Lipid identities HPLC -CAD Retention times
consistent with
referencesConforms to
referenceConforms to
referenceConforms to
referenceConforms to
referenceConforms to
reference
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149063
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 18Table 3.2.P.5.4 -4.Batch Analyses for Clinical BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
BCV40720 -A BCV40720 -B BCV40720 -C ED3938 EE3813
Results
Identity of encoded
RNA sequenceCapillary gel
electrophoresisMigration time of
the RNA conforms
to the migration
time of the
reference RNAConforms to
referenceConforms to
referenceConforms to
referenceConforms to
referenceConforms to
reference
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin (LAL)
Sterility Sterility Sterile Sterile Sterile Sterile Sterile Sterile
a. The information provided in this table represents the acceptance criteria used at the time of lot release.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; HPLC = High performance liquid chromatography; LAL = Limulus amebocyte
lysate; LNP = Lipid nanoparticle;
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149064
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 19Table 3.2.P.5.4 -5.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
EE8492 EE8493EJ0553 EJ0724 EJ1685 EJ1686
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)Essentially
free from
visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 7.4 ± 0.5
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149065
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 20Table 3.2.P.5.4 -5.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
EE8492 EE8493EJ0553 EJ0724 EJ1685 EJ1686
Container
content for
injectionsVolume of
injections in
containersNot less than
the sum of the
nominal values
ofNot less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of
Lipid
identitiesHPLC -CAD Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references (ALC -
0315, ALC-0159,
Cholesterol,
DSPC)Retention times
consistent with
references (ALC -
0315, ALC-0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references (ALC -
0315, ALC-0159,
Cholesterol,
DSPC)Retention times
consistent with
references (ALC -
0315, ALC-0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based
flow
cytometry
RNA
integrityCapillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
b.Acceptance criteria at the time of release w ere “Report result”. Most current E UA acceptance criteria reflected in this table .
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; EUA = Emergency use authorization; RP-HPLC = Reverse phase high performance
liquid chromatography; LAL = Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149066
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 21Table 3.2.P.5.4 -6.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality Attribute Analytical
ProcedureAcceptance
CriteriaaLot Number
EJ1688 EK4175 EK1768 EL0140EL0141
Results
Appearance Appearance (Visual) White to off -white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to off -
white suspension
Appearance (visible
particulates)Appearance
(Particles)Essentially free from
visible particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulatesEssentially free
from visible
particulates
Subvisible particles Subvisible
particulate matterMeets compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 7.4 ± 0.5
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP polydispersity Dynamic light
scattering (DLS)
RNA encapsulation Fluorescence assay
RNA content Fluorescence assay
ALC -0315 content HPLC -CAD
ALC -0159 content HPLC -CAD
DSPC content HPLC -CAD
Cholesterol content HPLC -CAD
Container content for
injectionsVolume of injections
in containersNot less than the
sum of the nominal
values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149067
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 22Table 3.2.P.5.4 -6.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality Attribute Analytical
ProcedureAcceptance
CriteriaaLot Number
EJ1688 EK4175 EK1768 EL0140EL0141
Results
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Choles terol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of encoded
RNA sequenceRT-PCR Identity confirmed Confirmed Confirmed Confirmed Confirmed Confirmed
In-vitro expression Cell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial endotoxin Endotoxin (LAL)
Sterility Sterility No growth detected No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
b.Acceptance criteria at the time of release w ere “Report result”. Most current EUA acceptance criteria reflected in this table .
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; EUA = Emergency use authorization; RP-HPLC = Reverse phase high performance
liquid chromatography; LAL = Limulus ameb ocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149068
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 23Table 3.2.P.5.4 -7.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
EL0142 EK4237 EK4243EK4244 EK4241
Results
Appearance Appearance
(Visual)White to off -
white suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspension
Appearance
(visible
particulates)Appearance
(Particles)Essentially free
from visible
particulatesEssentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate matterMeets
compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirements
pH 7.4 ± 0.5
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersNot less than the
sum of the
nominal values
of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149069
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 24Table 3.2.P.5.4 -7.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
EL0142 EK4237 EK4243EK4244 EK4241
Results
Lipid ide ntities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin (LAL)
Sterility Sterility No growth
detectedNo growth detected No growth detected No growth detected No growth detected No growth detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
b.Acceptance criteria at the time of release w ere “Report result”. Most current acceptance criteria reflected in this table.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reve rse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149070
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 25Table 3.2.P.5.4 -8.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality Attribute Analytical
ProcedureAcceptance
CriteriaaLot Number
EH9899 EK4176 EK5730EL0725
Results
Appearance Appearance (Visual) White to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspension
Appearance (visible
particulates)Appearance (Particles) Essentially free from
visible particulatesEssentially free from
visible particulatesEssentially free from
visible particulate sEssentially free from
visible particulatesEssentially free from
visible particulates
Subvisible particles Subvisible particulate
matterMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirements
pH 7.4 ± 0.5
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP polydispersity Dynamic light
scattering (DLS)
RNA encapsulation Fluorescence assay
RNA content Fluorescence assay
ALC -0315 content HPLC -CAD
ALC -0159 content HPLC -CAD
DSPC content HPLC -CAD
Cholesterol content HPLC -CAD
Container content for
injectionsVolume of injections
in containersNot less than the sum
of the nominal values
of Not less than the sum
of the nominal values
of .Not less than the sum
of the nominal values
of Not less than the sum
of the nominal values
of Not less than the sum
of the nominal values
of
Lipid identities HPLC -CAD Retention times
consistent with
references (ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references (ALC -
0315, ALC-0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)
Identity of encoded
RNA sequenceRT-PCR Identity confirmed Confirmed Confirmed Confirmed Confirmed
In-vitro expression Cell-based flow
cytometry
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149071
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 26Table 3.2.P.5.4 -8.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality Attribute Analytical
ProcedureAcceptance
CriteriaaLot Number
EH9899 EK4176 EK5730EL0725
Results
RNA integrity Capillary gel
electrophoresis
Bacterial endotoxin Endotoxin (LAL)
Sterility Sterility No growth detected No growth detected No growth detected No growth detected No growth detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149072
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 27Table 3.2.P.5.4 -9.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
EL0739 EK9231 EL1484EL1283 EL1284
Results
Appearance Appearance
(Visual)White to off -
white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspension
Appearance
(visible
particulates)Appearance
(Particles)Essentially free
from visible
particulatesEssentially free from
visible particulatesEssentially free from
visible particulatesEssentially free from
visible particulatesMeets .
Essentially free from
visible particulates.Meets.
Essentially free from
visible particulates
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirements
pH 7.4 ± 0.5
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersNot less than the
sum of the
nominal values
of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149073
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 28Table 3.2.P.5.4 -9.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaLot Number
EL0739 EK9231 EL1484EL1283 EL1284
Results
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth detected No growth detected No growth detected No growth detected No growth detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149074
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 29Table 3.2.P.5.4 -10.Batch Analyses for Network Process Performance Qualification BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EK4242 EL7834 EL1491 EL3248EL3249
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate
matter
Meets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149075
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 30Table 3.2.P.5.4 -10.Batch Analyses for Network Process Performance Qualification BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EK4242 EL7834 EL1491 EL3248EL3249
Results
Container
content for
injectionsVolume of
injections in
containersNot less than the
sum of the
nominal values
of Not less than Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC-0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.This commercial acceptance criterion refers to the vial content (volume) quality attribute and container content analytical p rocedure.
Abbreviations: CAD = Charged aerosol detection; EU = E ndotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149076
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 31Table 3.2.P.5.4 -11.Batch Analyses for Pfizer Puurs LNP and Pfizer Puurs Fill/Finish Process Performance Qualification
BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL8723 EM6950 EL8713 EP2163EP2166 EP6775 EW6126
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially
free from
visible
particulatesMeets.
Essentially
free from
visible
particulatesMeets.
Essentially
free from
visible
particulatesMeets testeMeets testeMeets.
Essentially
free from
visible
particulatesMeets.
Essentially
free from
visible
particulates
Subvisible
particlesSubvisible
particulate
matter
Meets com -
pendial re -
quirementsMeets com -
pendial re -
quirementsMeets com -
pendial re -
quirementsMeets com -
pendial re -
quirementsMeets com -
pendial re -
quirementsMeets com -
pendial re -
quirementsMeets com -
pendial re -
quire ments
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic
light
scattering
(DLS)
LNP poly -
dispersityDynamic
light
scattering
(DLS)
RNA encap -
sulationFluorescence
assay
RNA
contentFluorescence
assay
ALC -0315
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149077
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 32Table 3.2.P.5.4 -11.Batch Analyses for Pfizer Puurs LNP and Pfizer Puurs Fill/Finish Process Performance Qualification
BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL8723 EM6950 EL8713 EP2163EP2166 EP6775 EW6126
Results
ALC -0159
contentHPLC -CAD
DSPC
contentHPLC -CAD
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersdNot less than
the sum of the
nominal
values of N/A Not less
than the sum
of the
nominal
values of Not less
than the sum
of the
nominal
values of Not less
than the sum
of the
nominal
values of Not less
than the sum
of the
nominal
values of Not less
than the sum
of the
nominal
values of Not less
than the sum
of the
nominal
values of Not less
than the sum
of the
nominal
values of
Vial content
(volume)Container
contentdNot less than
mLNot less than
mLN/A N/A N/A Not less
than
mLNot less
than
mLNot less
than
mLNot less
than
mL
Lipid
identitiesHPLC -CAD Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
reference s
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded
RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based
flow
cytometry
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b)
(b)
(b)
(b)
(b)
(b)
(b) (4)
FDA-CBER-2021-5683-1149078
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 33Table 3.2.P.5.4 -11.Batch Analyses for Pfizer Puurs LNP and Pfizer Puurs Fill/Finish Process Performance Qualification
BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL8723 EM6950 EL8713 EP2163EP2166 EP6775 EW6126
Results
RNA integ -
rityCapillary gel
electropho -
resis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
d.Some lots were released using both volume of injections in containers and container content analytical procedures, while some were released usin g the
volume of injections in containers analytical procedure only.
e.Differences in reporting occurred due to changes in testing location.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; N/A = Not applicable; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149079
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 34Table 3.2.P.5.4 -12.Batch Analyses for Polymun Scientific LNP and Pfizer Puurs Fill/Finish Process Performance
Qualification BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EN1195 EN1196EM4965 ET0384
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially free from
visible particulatesMeets.
Essentially free from
visible particulatesMeets.
Essentially free from
visible particulatesMeets.
Essentially free from
visible particulates
Subvisible
particlesSubvisible
particulate matter
Meets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
require ments
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149080
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 35Table 3.2.P.5.4 -12.Batch Analyses for Polymun Scientific LNP and Pfizer Puurs Fill/Finish Process Performance
Qualification BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EN1195 EN1196EM4965 ET0384
Results
Container
content for
injectionsVolume of
injections in
containerscNot less than the
sum of the
nominal values
of N/A Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of
Vial content
(volume)Container
contentcNot less than Not less than Not less than Not less than Not less than Not less than
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC-0159,
Cholesterol, DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin (LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth detected No growth detected No growth detected No growth detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.Some lots were released using both volume of injections in containers and container content analytical procedures, while some were released using the
volume of injections in containers analytical procedure only.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; N/A = Not applicable; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149081
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 36Table 3.2.P.5.4 -13.Batch Analyses for Pfizer Kalamazoo LNP and Pfizer Kalamazoo Fill/Finish Process Performance
Qualification BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL9266 EL9267 EN6200 EN6198EN6199
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particula tes
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149082
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 37Table 3.2.P.5.4 -13.Batch Analyses for Pfizer Kalamazoo LNP and Pfizer Kalamazoo Fill/Finish Process Performance
Qualification BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL9266 EL9267 EN6200 EN6198EN6199
Results
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersdNot less than
the sum of the
nominal
values of N/A Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less t han the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of
Vial content
(volume)Container
contentdNot less than Not less than N/A N/A N/A Not less than Not less than
Lipid
identitiesHPLC -CAD Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based
flow
cytometry
RNA
integrityCapillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149083
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 38Table 3.2.P.5.4 -13.Batch Analyses for Pfizer Kalamazoo LNP and Pfizer Kalamazoo Fill/Finish Process Performance
Qualification BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL9266 EL9267 EN6200 EN6198EN6199
Results
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
d.Some lots were released using both volume of injections in containers and container content analytical procedures, while some were released using the
volume of injections in containers analytical procedu re only.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; N/A = Not applicable; RT-PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149084
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 39Table 3.2.P.5.4 -14.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EJ6795 EK4245 EJ6796 EJ6797 EK4238EK4240
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspensionWhite to off -
white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off -
white opaque,
amorphous
particlesMeets.
Essentially
free from
visible
particulatesMeets.
Essentially
free from
visible
particulatesMeets.
Essentially
free from
visible
particulatesMeets.
Essentially
free from
visible
particulatesMeets.
Essentia lly
free from
visible
particulatesMeets.
Essentially
free from
visible
particulates
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149085
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 40Table 3.2.P.5.4 -14.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EJ6795 EK4245 EJ6796 EJ6797 EK4238EK4240
Results
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersNot less than
the sum of the
nominal
values of Not less than Not less than
the sum of the
nominal
values of Not less than
the sum of the
nominal
values of Not less tha n
the sum of the
nominal
values of Not less than
the sum of the
nominal
values of Not less than
the sum of the
nominal
values of Not less than
the sum of the
nominal
values of
Lipid
identitiesHPLC -CAD Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consist ent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent wit h
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based
flow
cytometry
RNA
integrityCapillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.This commercial acceptance criterion refers to the vial content (volume) quality attribute and container content analytical p rocedure.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chro matography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b
)
(4)
(b
)
(4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149086
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 41Table 3.2.P.5.4 -15.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL3246 EJ3002 EL0200EL0203
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off- white
opaque,
amorphous
particlesMay contain white
to off -white
opaque, amorphous
particlesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate matterMeets compendial
requirementsMeets compendial
requirementsMeets compe ndial
requirementsMeets compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149087
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 42Table 3.2.P.5.4 -15.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL3246 EJ3002 EL0200EL0203
Results
Container content
for injectionsVolume of
injections in
containersNot less than the
sum of the
nominal values of Not less than Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity confirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin (LAL)
Sterility Sterility No growth
detectedNo growth detected No growth detected No growth detected No growth detected No growth detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149088
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 43Table 3.2.P.5.4 -16.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EM0477 EJ6134 EJ6136 EJ6788EL1404
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off -
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149089
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 44Table 3.2.P.5.4 -16.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EM0477 EJ6134 EJ6136 EJ6788EL1404
Results
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersNot less than
the sum of the
nominal values
of Not less than Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of
Lipid identities HPLC -CAD Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC-0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based
flow cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.This commercial acceptance criterion refers to the vial content (volume) quality attribute and container content analytical p rocedure.
Abbreviations: CAD = Charged aeros ol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149090
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 45Table 3.2.P.5.4 -17.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EK9788 EL1406 EN3924 EL3247EJ6789
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentia lly free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendi al
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149091
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 46Table 3.2.P.5.4 -17.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EK9788 EL1406 EN3924 EL3247EJ6789
Results
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersNot less than
the sum of the
nominal values
of Not less than Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Choles terol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.This commercial acceptance criterion refers to the vial content (volume) quality attribute and container content analytical procedure.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse tra nscription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149092
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 47Table 3.2.P.5.4 -18.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL3302 EL8982 EJ6790 EL9261EL9262
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149093
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 48Table 3.2.P.5.4 -18.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL3302 EL8982 EJ6790 EL9261EL9262
Results
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersNot less than
the sum of the
nominal values
of Not less than Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of Not less than the
sum of the
nominal values of
Lipid identities HPLC -CAD Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC-0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based
flow cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.This commercial acceptance criterion refers to the vial content (volume) quality attribute and container content analytical p rocedure.
Abbreviations: CAD = Charged aeros ol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149094
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 49Table 3.2.P.5.4 -19.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EN1185 EL9263 EN9581 EN5318EL9265
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulatesMeets.
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149095
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 50Table 3.2.P.5.4 -19.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EN1185 EL9263 EN9581 EN5318EL9265
Results
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersNot less than
the sum of the
nominal values
of Not less than Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of Not less than the
sum of the
nominal values
of
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC-0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.This commercial acceptance criterion refers to the vial content (volume) quality attribute and container content analytical p rocedure.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performanc e liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149096
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 51Table 3.2.P.5.4 -20.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL9269 EL9264 EM9809EM9810
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspensionWhite to off -white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off- white
opaque,
amorphous
particlesMay contain
white to off- white
opaque,
amorphous
particlesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulatesMeets .
Essentially free
from visible
particulates
Subvisible
particlesSubvisible
particulate matterMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirementsMeets compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering (DLS)
LNP
polydispersityDynamic light
scattering (DLS)
RNA
encapsulationFluorescence
assay
RNA content Fluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149097
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 52Table 3.2.P.5.4 -20.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EL9269 EL9264 EM9809EM9810
Results
Container content
for injectionsVolume of
injections in
containersNot less than the
sum of the
nominal values of Not less than Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of Not less than the
sum of the nominal
values of
Lipid identities HPLC -CAD Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)Retention times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol, DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based flow
cytometry
RNA integrity Capillary gel
electrophoresis
Bacterial
endotoxinEndotoxin (LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth detected No growth detected No growth detected No growth detected
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
c.This commercial acceptance criterion refers to the vial content (volume) quality attribute and container content analytical p rocedure.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; RT -PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
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FDA-CBER-2021-5683-1149098
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 53Table 3.2.P.5.4 -21.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EN6201 EP6017 EP9598 EP9605 ER1741EP6955
Results
Appearance Appearance
(Visual)White to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspensionWhite to
off-white
suspension
Appearance
(visible
particulates)Appearance
(Particles)May contain
white to off-
white
opaque,
amorphous
particlesMay contain
white to off-
white opaque,
amorphous
particlesMeets.
Essentially
free from
visible
particulatesMeets.
Essentially
free from
visible
particulatesMeets testbMeets testb Meets.
Essentially
free from
visible
particulatesMeets testb
Subvisible
particlesSubvisible
particulate
matterMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirementsMeets
compendial
requirements
pH 6.9 –7.9 6.9 –7.9
Osmolality Osmometry
LNP size Dynamic light
scattering
(DLS)
LNP
polydispersityDynamic light
scattering
(DLS)
RNA
encapsulationFluorescence
assay
RNA
contentFluorescence
assay
ALC -0315
contentHPLC -CAD
ALC -0159
contentHPLC -CAD
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
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FDA-CBER-2021-5683-1149099
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 54Table 3.2.P.5.4 -21.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EN6201 EP6017 EP9598 EP9605 ER1741EP6955
Results
DSPC content HPLC -CAD
Cholesterol
contentHPLC -CAD
Container
content for
injectionsVolume of
injections in
containersdNot less than
the sum of
the nominal
values of N/A Not less than
the sum of the
nominal
values of Not less than
the sum of the
nominal
values of N/A Not less than
the sum of the
nominal
values of Not less than
the sum of the
nominal
values of Not less than
the sum of the
nominal values
of
Vial content
(volume)Container
contentdNot less than Not less than Not less than Not less than Not less than Not less than Not less than Not less than
Lipid
identitiesHPLC -CAD Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent
with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)Retention
times
consistent with
references
(ALC -0315,
ALC -0159,
Cholesterol,
DSPC)
Identity of
encoded RNA
sequenceRT-PCR Identity
confirmedIdentity
confirmedConfirmed Confirmed Confirmed Confirmed Confirmed Confirmed
In-vitro
expressionCell-based
flow cytometry
RNA
integrityCapillary gel
electrophoresis
Bacterial
endotoxinEndotoxin
(LAL)
Sterility Sterility No growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detectedNo growth
detected
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
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FDA-CBER-2021-5683-1149100
BNT162b2
3.2.P.5.4. Batch Analyses
PFIZER CONFIDENTIAL
Page 55Table 3.2.P.5.4 -21.Batch Analyses for Emergency Supply BNT162b2 Drug Product Lots
Quality
AttributeAnalytical
ProcedureAcceptance
CriteriaaCommercial
Acceptance
CriteriaLot Number
EN6201 EP6017 EP9598 EP9605 ER1741EP6955
Results
a.The information provided in this table represents the acceptance criteria used at the time of lot release.
b.Differences in reporting occurred due to changes in testing location.
d.Some lots were released using both volume of injections in containers and container content analytical procedures, while some were released using the
volume of injections in containers analytical procedure only.
Abbreviations: CAD = Charged aerosol detection; EU = Endotoxin unit; RP -HPLC = Reverse phase high performance liquid chromatography; LAL =
Limulus amebocyte lysate; LNP = Lipid nanoparticle; N/A = Not applicable; RT-PCR = Reverse transcription PCR
090177e19700ab4f\Approved\Approved On: 12-May-2021 07:29 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149101