Document text
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 1
3.2.P.8.3. STABILITY DATA – THERMAL – STRESS AND CYCLING ............................ 3
LIST OF TABLES
Table 3.2.P.8.3-1. Summary of Drug Product Thermal Stability Studies ................................ 4
Table 3.2.P.8.3-2. Stability Data for Drug Product PPQ L ot EL8723 Stored at 25 ± 2
°C/60 ± 5% RH ................................ ................................ ........................... 6
Table 3.2.P.8.3-3. Stability Data for Drug Product PPQ L ot EL8723 Stored at 30 ± 2
°C/65 ± 5% RH ................................ ................................ ........................... 7
Table 3.2.P.8.3-4. Stability Data for Drug Product PPQ L ot EL3248 Stored at 25 ± 2
°C/60 ± 5% RH ................................ ................................ ........................... 8
Table3.2.P.8.3-5. Stability Data for Drug Product PPQ L ot EL3248 Stored at 30 ± 2
°C/65 ± 5% RH ................................ ................................ ........................... 9
Table 3.2.P.8.3-6. Stability Data for Drug Product Emergency Supply Batch EH9899
Stored at 25 ± 2 °C/60 ± 5% RH ................................ .............................. 10
Table 3.2.P.8.3-7. Stability Data for Drug Product Emerg ency Supply Batch EJ1688
Stored at 25 ± 2 °C/60 ± 5% RH ................................ .............................. 11
Table 3.2.P.8.3-8. Stability Data for Drug Product Emergency Supply Batch EK1768
Stored at 25 ± 2 °C/60 ± 5% RH ................................ .............................. 12
Table 3.2.P.8.3-9. Stability Data for Drug Product Emergency Supply Batch EJ1686
Stored at 25 ± 2 °C/60 ± 5% RH ................................ .............................. 13
Table 3.2.P.8.3-10. Stability Data for Drug Product Emergency Supply Batch EJ1685
Stored at 25 ± 2 °C/60 ± 5% RH................................ .............................. 14
Table 3.2.P.8.3-11. Stability Data for Drug Product Emergency Supply Batch EJ0553
Stored at 25 ± 2 °C/60 ± 5% RH ................................ .............................. 15
Table 3.2.P.8.3-12. Stability Data for Drug Product EE8493 Stored at 25 ± 2 °C/60 ±
5% RH ................................ ................................ ................................ ......16
Table 3.2.P.8.3-13. Stability Data for Drug Product EE8493 Stored at 30 ± 2 °C/65 ±
5% RH ................................ ................................ ................................ ......17
Table 3.2.P.8.3-14. Stability Data for Pol ymun Scientific Drug Product BNT162b2 Lot
BCV40420 -A Stored at 25 ± 2 °C ................................ ............................ 18
Table 3.2.P.8.3-15. Thermal Cy cling Stability Data for Drug Product Emergency
Supply Batch EK1768 ................................ ................................ .............. 19
Table 3.2.P.8.3-16. Thermal Cy cling Stability Data for Drug Product Emergency
Supply Batch EJ1686 ................................ ................................ ................ 20
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FDA-CBER-2021-5683-1149216
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 2Table 3.2.P.8.3-17. Thermal Cy cling Stability Data for Drug Product PPQ L ot EN1195 ......22
Table 3.2.P.8.3-18. Thermal Cy cling Stability Data for Drug Product PPQ L ot EL 9266....... 24
Table 3.2.P.8.3-19. Thermal Cy cling Stability Data for Drug Product PPQ L ot EL8723....... 26
Table 3.2.P.8.3-20. Thermal Cy cling Stability Data for Drug Product PPQ L ot EL3249....... 28
Table 3.2.P.8.3-21. Thermal Cy cling Stability Data for Drug Product PPQ L ot EK4242 ......30
Table 3.2.P.8.3-22. Thermal Cy cling Stability Data for Drug Product PPQ L ot EL7834....... 31
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149217
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 33.2.P.8.3. STABILITY DATA – THERMAL – STRESS AND CYCLING
Data from stability studie s on BNT162b2 drug product lotsstored at the thermal stress
conditions of 252C/60± 5% RH and 30 2 C/65 ± 5% RH , as well as thermal cy cling
studies, are presented for emergency supply and process performance qualification lots
manufactured by Polymun Scientific (with fill and finish at Pfizer, Puurs), mibe (with fill and
finish at Pfizer, Puurs), Pfizer, Puurs and Pfizer, Kalamazoo, MI .
Additionally , data from supportive stability studies for oneclinical BNT162b2 drug produc t
lot stored at the thermal stress condition of 25 2 C and manufactured b y Polymun
Scientific isalso presented.
All studies are listed in Table 3.2.P.8.3-1 . Results will be provided in Table 3.2.P.8.3-2
through Table 3.2.P.8.3-22.
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FDA-CBER-2021-5683-1149218
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 4Table 3.2.P.8.3 -1. Summary of Drug Product Thermal Stability Studies
Lot Number Drug Product
Batch UseStability
Start DateStudy Type Storage Condition Stability Data
PresentedData Table Location
EL8723
(Pfizer, Puurs)Stability, Clinical,
Emergency Supplya,
Process performance
qualificationJanuary 2021
(TC Study:
February
2021)Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -2
Thermal Stress 30 ±2 °C/65 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -3
Thermal Cycling: Ultra frozen vials are placed at -20 ±
5 °C for 4 weeks and then moved to 2 to 8 °C for 12
weeks. Samples will be pulled for testing every 2 weeks
throughout protocol.8weeks
(On-going)Table 3.2.P.8.3 -19
EL3248
(Pfizer, Kalamazoo,
Line )Stability, Clinical,
Emergency Supplya,
Process performance
qualificationDecember
2020Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -4
Thermal Stress 30 ±2 °C/65 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -5
EN1195
(mibe/Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationFebruary
2021Thermal Cycling: Ultra frozen vials are placed at -20 ±
5 °C for 4 weeks and then moved to 2 to 8 °C for 12
weeks. Samples will be pulled for testing every 2 weeks
throughout protocol.6weeks
(On-going)Table 3.2.P.8.3 -17
EL9266
(Pfizer, Kalamazoo,
Line )Stability, Emergency
Supplya, Process
performance
qualificationFebruary
2021Thermal Cycling: Ultra frozen vials are placed at -20 ±
5 °C for 4 weeks and then moved to 2 to 8 °C for 12
weeks. Samples will be pulled for testing every 2 weeks
throughout protocol.8weeks
(On-going)Table 3.2.P.8.3 -18
EL3249
(Pfizer, Kalamazoo,
Line )Stability, Clinical,
Emergency Supplya,
Process performance
qualificationJanuary 2021 Thermal Cycling: 1 week at -90 to -60°C , followed by
2 weeks at -20 ±5 °C, 4 weeks at 2 to 8 °C and 1 week
at 25 ± 2 °C/60 ±5% RH.8weeks
(Complete )Table 3.2.P.8.3 -20
EK4242
(mibe/Pfizer, Puurs)Stability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 Thermal Cycling: 1 week at -90 to -60°C followed by 4
weeks at 2 to 8 °C5 weeks
(Complete)Table 3.2.P.8.3 -21
EL7834
(Polymun
Scientific/Pfizer, PuursStability, Emergency
Supplya, Process
performance
qualificationJanuary 2021 Thermal Cycling: 1 week at -90 to -60°C followed by 4
weeks at -20 ±5 °C and then 4 weeks at 2 to 8 °C. and 1
week at 25 ±2 °C/60 ±5% RH.10weeks
(Complete )Table 3.2.P.8.3 -22
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b
(b
)
(
FDA-CBER-2021-5683-1149219
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 5Table 3.2.P.8.3 -1. Summary of Drug Product Thermal Stability Studies
Lot Number Drug Product
Batch UseStability
Start DateStudy Type Storage Condition Stability Data
PresentedData Table Location
EH9899
Pfizer, Kalamazoo)Stability, Emergency
SupplyaNovember
2020Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -6
EJ1688
(mibe/Pfizer, Puurs)Stability, Emergency
SupplyaNovember
2020Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -7
EK1768
(Polymun
Scientific/Pfizer, PuursStability, Emergency
Supplya, Clinical
inventoryNovember
2020 Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -8
Thermal Cycling: 2 weeks at -90 to -60°C followed by
4 weeks at -20 ±5 °C and then 8 weeks at 2 to 8 °C.
Samples will be pulled for testing every 2 weeks
throughout protocol.14weeks
(Complete )Table 3.2.P.8.3 -15
EJ1686
(Polymun
Scientific/Pfizer, PuursStability, Emergency
Supplya, Clinical
inventoryNovember
2020 Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -9
Thermal Cycling: 2 weeks at -90 to -60°C followed by
4 weeks at -20 ±5 °C and then 8 weeks at 2 to 8 °C.
Samples will be pulled for testing every 2 weeks
throughout protocol.14weeks
(Complete )Table 3.2.P.8.3 -16
EJ1685
(Polymun
Scientific/Pfizer, PuursStability, Emergency
Supplya, Clinical
inventoryNovember
2020 Thermal S tress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -10
EJ0553
(Polymun
Scientific/Pfizer, PuursStability, Emergency
Supplya, Clinical
inventoryNovember
2020 Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -11
EE8493
(Polymun
Scientific/Pfizer,
Puurs)Stability, Emergency
Supplya, Clinical
inventorySeptember
2020Thermal Stress 25 ±2 °C/60 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -12
Thermal Stress 30 ±2 °C/65 ±5% RH 1 month
(Complete)Table 3.2.P.8.3 -13
BCV40420 -A
(Polymun Scientific)Stability, Clinical May 2020 Thermal Stress 25 ±2 °C 4 months
(complete)Table 3.2.P.8.3 -14
a. Emergency supply designation applies to US market.
b. A minimum of one PPQ lot will be enrolled in thermal stress and thermal cycling stability programs compliant with ICH Guideli nes and further information on lot numbers,
manufacture, stability enrollment and available data will be provided in the future.
TBD = To Be Determined
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
FDA-CBER-2021-5683-1149220
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 6Table 3.2.P.8.3 -2.Stability Data for Drug Product PPQ Lot EL8723 Stored at 25 ± 2 °C/60 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off-white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 b WOS Meets
1W WOS Meets
2W WOS Meets
1M WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
1M
a. Acceptance criteria in place at time of testing.
b. T=0 testing performed for this lot (release values not utilized.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149221
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 7Table 3.2.P.8.3 -3.Stability Data for Drug Product PPQ Lot EL8723 Stored at 30 ± 2 °C/65 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off-white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 b WOS Meets
1W WOS Meets
2W WOS Meets
1M WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
1M
a. Acceptance criteria in
b. T=0 testing performed for this lot (release values not utilized.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aeros ol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149222
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 8Table 3.2.P.8.3 -4.Stability Data for Drug Product PPQ Lot EL3248 Stored at 25 ± 2 °C/60 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off-white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOS Meets
1W WOS Meets
2W WOS Meets
3W WOS Meets
1M WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
3W
1M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOS = White to off -white suspen sion
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149223
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 9Table 3.2.P.8.3 -5.Stability Data for Drug Product PPQ Lot EL3248 Stored at 30 ± 2 °C/65 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off-white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 WOS Meets
1W WOS Meets
2W WOS Meets
3W WOS Meets
1M WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
3W
1M
a. Acceptance criteria in place at time of testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149224
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 10Table 3.2.P.8.3 -6. Stability Data for Drug Product Emergency Supply Batch EH9899 Stored at 25 ± 2 °C/60 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off-white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 b White to off -white suspension
1W White to off -white suspension
2W White to off -white suspension
1M White to off -white suspension
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
1M
a. Acceptance criteria in place at time of testing . Current effective acceptance criteria established at the 1 week time point.
b. T=0 testing performed for this lot (release values not utilized.
c. Result invalidated and not repeated as 1 month time point was pulled for testing.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149225
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 11Table 3.2.P.8.3 -7. Stability Data for Drug Product Emergency Supply Batch EJ1688 Stored at 25 ± 2 °C/60 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off -white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 White to off -white suspension
1W White to off -white suspension
2W White to off -white suspension
1M White to off -white suspension Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
1M
a. Acceptance criteria in place at time of testing. Current effective acceptance criteria established at the 1 month time point.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performan ce liquid chromatography -charged aerosol detector
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149226
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 12Table 3.2.P.8.3 -8. Stability Data for Drug Product Emergency Supply Batch EK1768 Stored at 25 ± 2 °C/60 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off -white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 White to off -white suspension
1W White to off -white suspension Meets
2W White to off -white suspension Meets
1M White to off -white suspension Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
1M
a. Acceptance criteria in place at time of testing. Current effective acceptance criteria established at the 1 week time point.
W = Week, M = Month, S = To be S cheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149227
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 13Table 3.2.P.8.3 -9.Stability Data for Drug Product Emergency Supply Batch EJ168 6Stored at 25 ± 2 °C/60 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
0b White to off -white suspension
1W White to off -white suspension Meets
2W White to off -white suspension Meets
1M White to off -white suspension Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
0b
1W
2W
1M
a. Acceptance criteria in place at time of testing. Current effective acceptance criteria established at the 1 week time point.
b. T=0 testing performed for this lot (release values not utilized.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149228
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 14Table 3.2.P.8.3 -10. Stability Data for Drug Product Emergency Supply Batch EJ1685 Stored at 25 ± 2 °C/60 ± 5% RH
Analyt ical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off -white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 White to off -white suspension
1W White to off -white suspension
2W White to off -white suspension Meets
1M White to off -white suspension Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
1M
a. Acceptance criteria in place at time of testing. Current effective acceptance criteria established at the 2 week time point.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149229
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 15Table 3.2.P.8.3 -11. Stability Data for Drug Product Emergency Supply Batch EJ0553 Stored at 25 ± 2 °C/60 ± 5% RH
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off -white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
0 White to of f-white suspension
1W White to off -white suspension
2W White to off -white suspension
1M White to off -white suspen sion
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
0
1W
2W
1M
a. Acceptance criteria in place at time of testing. Current effective acceptance criteria established at the 1 month time point.
W = Week, M = Month, S = To be Scheduled, NS = Not Scheduled at Time Point; ; LNP = Lipid Nanoparticle; HPLC-CAD
=high performance liquid chromatography -charged aerosol detector
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149230
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 16Table 3.2.P.8.3 -12. Stability Data for Drug Product EE8493 Stored at 25 ± 2 °C/60 ± 5 % RH
Time Appearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visible) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Acceptance
CriteriaaWhite to off -white suspension 7.4 ± 0.5
0 White to off -white suspension
2W White to off -white suspension
1M White to off -white suspension
Time HPLC -CAD Cell-based Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159
ContentDSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results
(mg/mL)Report Results
(mg/mL)% Cells Positive
0
2W
1M
a. Acceptance criteria in place at time of testing.
b. Original result investigated and invalidated with no result being reported.
W = Week, M = Month, S = To be Scheduled, , LNP = Lipid Nanoparticle, MCR = Meets Compendial Requirements
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149231
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 17Table 3.2.P.8.3 -13.Stability Data for Drug Product EE8493 Stored at 30 ± 2 °C/65 ± 5 % RH
Time Appearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visible) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Acceptance
CriteriaaWhite to off -white suspension 7.4 ± 0.5
0 White to off -white suspension
2W White to off -white suspension
1M White to off -white suspension
Time HPLC -CAD Cell-based Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159
ContentDSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Acceptance
CriteriaaReport Results
(mg/mL)Report Results
(mg/mL)Report Results
(mg/mL)Report Results
(mg/mL)% Cells Positive
0
2W
1M
a. Acceptance criteria in place at time of testing.
b. Original result investigated and invalidated with no result reported.
W = Week, M = Month, S = To be Scheduled, , LNP = Lipid Nanoparticle, MCR = Meets Compendial Requirements
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b)
(b)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149232
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 18Table 3.2.P.8.3 -14.Stability Data for Polymun Scientific Drug Product BNT 162b2 Lot BCV40420 -A Stored at 25 ± 2 °C
Time
(Month s)Appearance pH LNP Size LNP Polydispersity RNA Encapsulation RNA Content
Acceptance
CriteriaaWhite to off -white
suspension/Free from
observable particles7.4 ± 0.5
0 Pass
0.5 Pass NS
1 Pass NS
2 Pass NS
3 Pass
4 Pass NS
Time
(Month s)ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content RNA Integrity
Acceptance
CriteriaaReport Result s(mg/mL) Report Result s(mg/mL) Report Result s(mg/mL) Report Result s(mg/mL)
0
0.5
1
2
3
4
a. Acceptance criteria in place at time of testing.
S = Scheduled, NS = Not Scheduled at Time Point, LNP = Lipid Nanoparticle
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149233
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 19Table 3.2.P.8.3 -15.Thermal Cycling Stability Data for Drug Product Emergency Supply Batch EK1768
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint / Acceptance
Criteriaa White to off -white suspension May contain white to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -90 to -60°C (for 2 weeks)
0 WOS
Samples pulled for 2W testing. Inventory moved to -20 ± 5°C (for 4 weeks)
2W WOS Meets
4W WOS Meets
Samples pulled for 6W testing. Inventory moved to 2 to 8 °C for remainder of study
6W WOS Meets
8W WOS Meets
10W WOS Meets )
12W WOS Meets
14W WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytometry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol Content In Vitro Expression RNA Integrity
Timepoint / Acceptance
Criteriaa
Placed @ -90 to -60°C (for 2 weeks)
0
Samples pulled for 2W testing. Inventory moved to -20 ± 5°C (for 4 weeks)
2W
4W
Samples pulled for 6W testing. Inventory moved to 2 to 8 °C for remainder of study
6W
8W
10W
12W
14W
a. Acceptance criteria in place at time of testing. Current effective acceptance criteria established at the 8 week time point.
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high performance liquid chromatography -
charged aerosol detector , WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149234
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 20Table 3.2.P.8.3 -16. Thermal Cycling Stability Data for Drug Product Eme rgency Supply Batch EJ1686
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -90 to -60°C (for 2 weeks)
0bWOS
Samples pulled for 2W testing. Inventory moved to -20 ± 5°C (for 4 weeks)
2W WOS Meets
4W WOS Meets
Samples pulled for 6W testing. Inventory moved to 2 to 8 °C for remainder of study
6W WOS Meets
8W WOS Meets
10W WOS Meets
12W WOS Meets
14W WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
Placed @ -90 to -60°C (for 2 weeks)
0b
Samples pulled for 2W testing. Inventory moved to -20 ± 5°C (for 4 weeks)
2W
4W
Samples pulled for 6W testing. Inventory moved to 2 to 8 °C for remainder of study
6W
8W
10W
12W
14W
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149235
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 21Table 3.2.P.8.3 -16. Thermal Cycling Stability Data for Drug Product Eme rgency Supply Batch EJ1686
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
a. Acceptance criteria in place at time of testing. Current effective acceptance criteria established at the 8 week time point.
b. Initial data (t0) are not from release testing. Analysis for t0 were repeated for this study.
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high performance liquid chromatography -
charged aerosol detector ,WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149236
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 22Table 3.2.P.8.3 -17. Thermal Cycling Stability Data for Drug Product PPQ Lot EN1195
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -20 ± 5°C (for 4weeks)
0 WOS Meets
2W WOS Meets
4W WOS Meets
Samples pulled for 4W testing. Inventory moved to 2 to 8 °C for remainder of study
6W WOS Meets
8W S S S S S S S
10W S S S S S S S
12W S S S S S S S
14W S S S S S S S
16W S S S S S S S
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
Placed @ -20 ± 5°C (for 4 weeks)
0
2W
4W
Samples pulled for 4W testing. Inventory moved to 2 t o 8 °C for remainder of study
6W
8W S S S S S S
10W S S S S S S
12W S S S S S S
14W S S S S S S
16W S S S S S S
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149237
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 23Table 3.2.P.8.3 -17. Thermal Cycling Stability Data for Drug Product PPQ Lot EN1195
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
a. Acceptance criteria in place at time of testing .
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high performance liquid chromatography -
charged aerosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149238
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 24Table 3.2.P.8.3 -18. Thermal Cycling Stability Data for Drug Product PPQ Lot EL9266
Analytica l
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -20 ± 5°C (for 4 weeks)
0b WOS Meets
2W WOS Meets
4W WOS Meets
Samples pulled for 4W testing. Inventory moved to 2 to 8 °C for remainder of study
6W WOS Meets
8W WOS Meets
10W S S S S S S S
12W S S S S S S S
14W S S S S S S S
16W S S S S S S S
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
Placed @ -20 ± 5°C (for 4 weeks)
0b
2W
4W
Samples pulled for 4W testing. Inventory moved to 2 to 8 °C for remainder of study
6W
8W
10W S S S S S S
12W S S S S S S
14W S S S S S S
16W S S S S S S
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149239
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 25Table 3.2.P.8.3 -18. Thermal Cycling Stability Data for Drug Product PPQ Lot EL9266
Analytica l
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
a. Acceptance criteria in place at time of testing .
b. Initial data (t0) are not from release testing. Analysis for t0 were repeated for this study.
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high performance liquid chromatography -
charged aerosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149240
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 26Table 3.2.P.8.3 -19.Thermal Cycling Stability Data for Drug Product PPQ Lot E L8723
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -20 ± 5°C (for 4 weeks)
0b WOS Meets
2W WOS Meets
4W WOS Meets
Samples pulled for 4W testing. Inventory moved to 2 to 8 °C for remainder of study
6W WOS Meets
8W WOS Meets
10W S S S S S S S
12W S S S S S S S
14W S S S S S S S
16W S S S S S S S
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
Placed @ -20 ± 5°C (for 4 weeks)
0b
2W
4W
Samples pulled for 4W testing. Inventory moved to 2 to 8 °C for remainder of study
6W
8W
10W S S S S S S
12W S S S S S S
14W S S S S S S
16W S S S S S S
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149241
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 27Table 3.2.P.8.3 -19.Thermal Cycling Stability Data for Drug Product PPQ Lot E L8723
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
a. Acceptance criteria in place at time of testing .
b. Initial data (t0) are not from release testing. Analysis for t0 were repeated for this study.
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high performance liquid chromatography -
charged ae rosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149242
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 28Table 3.2.P.8.3 -20.Thermal Cycling Stability Data for Drug Product PPQ Lot E L3249
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -90 to -60 °C (for 1 week)
0 WOS Meets
At 1W, inventory moved to -20 ±5 °C (for 2 weeks)
3W WOS Meets
Samples pulled for 3W testing. Inventory moved to 2 to 8 °C (for 4 weeks)
4W WOS Meets
5W WOS Meets
6W WOS Meets
7W WOS Meets
Samples pulled for 7W testing. Inventory moved to 25 ±2 °C/60 ±5% RH (for 1 week)
8W WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
Placed @ -90 to -60 °C (for 1 week)
0
At 1W, inventory moved to -20 ± 5 °C (for 2 weeks)
3W
Samples pulled for 3W testing. Inventory moved to 2 to 8 °C (for 4 weeks)
4W
5W
6W
7W
Samples pulled for 7W testing. Inventory moved to 25 ± 2 °C/60 ± 5% RH (for 1 week)
8W
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149243
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 29Table 3.2.P.8.3 -20.Thermal Cycling Stability Data for Drug Product PPQ Lot E L3249
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
a. Acceptance criteria in place at time of testing .
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high performance liquid chromatography -
charged aerosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149244
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 30Table 3.2.P.8.3 -21.Thermal Cycling Stability Data for Drug Product PPQ Lot E K4242
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -90 to -60 °C (for 1week)
0 WOS Meets
At 1W, inventory moved to 2 to 8 °C for remainder of study (4 weeks)
2W WOS Meets
3W WOS Meets
4W WOS Meets
5W WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
Placed @ -90 to -60 °C (for 1 week)
0
At 1W, inventory moved to 2 to 8 °C for remainder of study (4 weeks)
2W
3W
4W
5W
a. Acceptance criteria in place at time of testing .
b. Initial data (t0) are not from release testing. Analysis for t0 were repeated for this study.
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high performance liquid chromatography -
charged aerosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149245
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 31Table 3.2.P.8.3 -22.Thermal Cycling Stability Data for Drug Product PPQ Lot EL 7834
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
Timepoint /
Acceptance Criteriaa White to off -white
suspensionMay contain w hite to
off-white opaque,
amorphous particles7.4 ± 0.5
Placed @ -90 to -60 °C (for 1 week)
0 WOS Meets
At 1W, inventory moved to -20 ±5 °C (for 4weeks)
3W WOS Meets
5W WOS Meets
Samples pulled for 5W testing. Inventory moved to 2 to 8 °C (for 4 weeks)
6W WOS Meets
7W WOS Meets
8W WOS Meets
9W WOS Meets
Samples pulled for 7W testing. Inventory moved to 25 ±2 °C/60 ±5% RH (for 1 week)
10W WOS Meets
Analytical
Procedure /Quality
AttributeHPLC -CAD Cell-based Flow Cytom etry Capillary Gel
Electrophoresis
ALC -0315 Content ALC -0159 Content DSPC Content Cholesterol
ContentIn Vitro Expression RNA Integrity
Timepoint /
Acceptance Criteriaa
Placed @ -90 to -60 °C (for 1 week)
0
At 1W, inventory moved to -20 ± 5 °C (for 4 weeks)
3W
5W
Samples pulled for 5W testing. Inventory moved to 2 to 8 °C (for 4 weeks)
6W
7W
8W
9W
Samples pulled for 7W testing. Inventory moved to 25 ± 2 °C/60 ± 5% RH (for 1 week)
10W
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
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(b) (4)
FDA-CBER-2021-5683-1149246
BNT162b2
3.2.P.8.3. Stability Data
Thermal –Stress and Cycling
PFIZER CONFIDENTIAL
Page 32Table 3.2.P.8.3 -22.Thermal Cycling Stability Data for Drug Product PPQ Lot EL 7834
Analytical
Procedure /Quality
AttributeAppearance pH Dynamic Light Scattering (DLS) Fluorescence Assay
Appearance (Visual) Visible Particulates LNP Size LNP
PolydispersityRNA
EncapsulationRNA Content
a. Acceptance criteria in place at time of testing .
b. Initial data (t0) are not from release testing. Analysis for t0 were repeated for this study.
W = Week, S = To be Scheduled, , LNP = Lipid Nanoparticle, HPLC-CAD = high perform ance liquid chromatography -
charged aerosol detector, WOS = White to off -white suspension
090177e19703fd1a\Approved\Approved On: 12-May-2021 12:40 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149247