125742 S42 M3 32r comirnaty lot release template
Document text
Page 1 of 1Food and Drug Administration Reason for Submission
Center for Biologics Evaluation and Research For Release
Sample Custodian For Surveillance
10903 New Hampshire Avenue For Licensing Action*
WO75 -G707 STN: ______________
Silver Spring, MD 20993 -0002 For Corrected Letter
Date :
Subject: Electronic Protocol Signature Page
License No.: 0000 Company Name:____________________
[COMPANY NAME] hereb y submits the following lot as an electronic submission by
Electronic Submissions Gateway (ESG). All test conducted on this lot are reported and pass
specifications as required.
Proper name of product
Electronic Protocol
STN Lot Number Lot T ype Filename
125742 _0 000000000 FC 20100001.P0
Sample Status
Sample Not Required
Sample Submitted with Protocol
Sample Previous Submitted: [DATE]
Virus Verification
Software Name:
Company Name: Version:
Date of Definitions: DD/MM/YYYY Date of Scan: DD/MM/YYYY
I certify that the submission is virus -free.
The approximate file size of this submission is ___ KB/MB.
Comments:
Signature of Authorized Official
Printed Name and Title of Signatory Title
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Page 1 of y
Lot Number:
License Name of Product:
Reason For Submission
__ For Release
__ For Surveillance
__ For Licensing Action
Manufacturer Name: STN:
__ Corrected Protocol
Manufacturer Address:
Trade name:
Date of Manufacturing: 00/0 0/0000 Expiration Date: 00/00/0000
Fill Inform ation
Filling Date: 00/00/0000
Location:
Total Volume: 000 mL
Volume per Vial: 000 mL
Number of Vials filled: 0000
Storage Temperature:
All tests conducted on this lot are reported and pass specifications as required.
Signature: Date:
Title: Authorized Official
Electronic Protocol # - 202xxxxx.P0
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Page 1of 9Reason for Submission
For Release
For Surveillance
For Licensing Action*
STN: ______________
Corrected Protocol
cc: STN 125742 -0/2229/FC
LotNum ber:
Licen seNam eofProduct:
Marketing Authori sation Holder Name and Address:
Manufacturing Site :
Date of Manufacture: Date of Expiry:
Date of Fill:
Product Inform ation :
COMPONENTS
Component DescriptionBatch
NumberDate of
Manuf.Manufacture Site QuantityTarget
Concentration
BNT162b2
Drug Substance
LNP Fabrication N/A
Bulk Drug Product
Form ulationN/A
FILL INFORMATION
Container Type: Volum e per container:
Approved Storage Period: Storage Temperature:
Num berofcontainers manufactured :
Num berof Doses per
container:
Num berofcontainers for release:
Volum eof single human dose:Start Date of period of
Validity:
All lot release tests conducted on this lot, as per the product license are reported and pass specifications as
required.
Prepared By: Approved By:
Electronic Protocol # - 202xxxxx.P0
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LotNum ber:
Licen seNameofProduct:
Table 1. Filled Vaccine Quality Control Tests
Test Test Method Specification Date of Tes t Result
Appearance Appearance (Visual)White to off-white
suspension
Appearance (Visible
Particulates)Appearance (Particles)May contain white to off -
white opaque amorphous
particles
Subvisible ParticlesSubvisible Particulate
Matter
pH 6.9 -7.9
Osmolality Osmometry
LNP SizeDynamic Light
Scattering (DLS)
LNP PolydispersityDynamic 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
Vial content Container Content
Lipid identities HPLC -CADRetention times
consistent with
references (ALC -0315,
ALC -0159, Cholesterol,
DSPC)
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LotNum ber:
Licen seNameofProduct:
Table 1 (Continued) Filled Vaccine Quality Control Tests
Test Test Method Specification Date of Test Result
Identity of encoded
RNA sequenceRT-PCR Identity confirmed
In Vitro ExpressionCell-based Flow
Cytometry
RNA IntegrityCapillary Gel
Electrophoresis
Bacterial Endotoxin Endotoxin (LAL)
Abbreviations: LNP = Lipid nanoparticles; CAD = charged aerosol detector; RT -PCR = reverse transcription
polymerase chain reaction; LAL = Limulus amebocyte lysate; EU = endotoxin unit
Filled Vaccine Quality Control Tests (cont.)
Sterility
Method: Type: Final Container
Container :Sterility -
Date OnTest Medium /Temperature Date OffTest Specification Test Result
Nogrowth observed
Nogrowth observed
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LotNum ber:
License Nam eofProduct:
Filled Vaccine Quality Control Tests (Continued)
RNA encapsulation and content test
Test date
Test method __________________
Specification : RNA Encapsulation Result ________
Specification : Content RNA Content Result __________
Sample/Control Acceptance Criteria Result
R2for Standard A
R2for Standard B
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LotNum ber:
License Nam eofProduct:
Filled Vaccine Quality Control Tests (Continued)
Identity of encoded RNA sequence test
Test method __ RT-PCR _________
Test date
Specification Identity confirm ed Result __________________
Sample/Control Lot
numberReplicate Ct value Acceptance
criteriaPass/Fail
DP Sample 1
2
3
Positive PCR Control 1
2
3
Positive
Control1
2
3
Negative PCR Control 1
2
3
Negative
Control1
2
3
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LotNum ber:
License Nam eofProduct:
Filled Vaccine Quality Control Tests (Continued)
In Vitro Expression Assay
Test date
Test method __________________
Specification cells positive
Lot number
Positive Control lot number
% cell viability
Average Num ber of Cells Counted for Sample
Test Result (% positive cells)
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LotNum ber:
License Nam eofProduct:
Filled Vaccine Quality Control Tests (Continued)
Limulus A mebocyte Lysate Test
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LotNum ber:
License Nam eofProduct:
Filled Vaccine Quality Control Tests (Continued)
Limulus A mebocyte Lysate Test
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LotNum ber:
License NameofProduct:
BNT162b2 Drug Substance
Lot Number: Manufacturing Site :
Date of Manufacture: Date of Expiry:
Storage Tem perature: Approved Storage Period :
Consumed Quantity:
Table 1. Drug Substance Quality Control Tests
Test Test Method Specification Date of Test Result
Clarity Appearance (Clarity)
ColorationAppearance
(Coloration)
pH
Content (RNA
Concentration)UV Spectroscopy
Identity of Encoded
RNA SequenceRT-PCR
RNA IntegrityCapillary Gel
Electrophoresis
5’-Cap RP-HPLC
Poly(A) Tail ddPCR
Residual DNA Template qPCR
Residual dsRNA Immunoblot
Bacterial Endotoxin Endotoxin (LAL)
Bioburden Bioburden
Abbreviations: NTU = Nephelometric Turbidity Units; B = brown; RT -PCR = reverse transcription polymerase
chain reaction; ddPCR = droplet digital PCR; qPCR = quantitative PCR; dsRNA = double stranded RNA;
LAL = Limulus amebocyte lysate; EU = endotoxin unit; CFU = colon y forming unit
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Genealogy Flowchart
Page 1of 1Prepared By: Approved By:
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