125742 S2 M3 32s4 specification

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BNT162b2
3.2.S.4.1 Specification
PFIZER CONFIDENTIAL
Page 13.2.S.4.1. SPECIFICATION
The specification for BNT 162b2drug substance at release and during stability  studies is 
provided in Table 3.2.S.4.1 -1.  
The acceptance criteria provided are based on the available data. 
Table 3.2.S.4.1-1 BNT162b2 Drug Substance Specification
Quality Attribute Analytical Procedure Acceptance Criteri a 
Composition and Strength
Clarity Appearance (Clarity)
(Ph. Eur. 2.2.1)
Coloration Appearance (Coloration)
(Ph. Eur. 2.2.2)
pH
(Ph. Eur. 2.2.3, USP <791>)
Content (RNA 
Concentration)UV Spectroscopy
Identity
Identity of Encoded RNA 
SequenceRT-PCRa
Purity
RNA Integrity Capillary Gel Electrophoresis
5’-Cap RP-HPLC 
Poly(A) Tail ddPCR 
Process Related Impurit ies
Residual DNA Template qPCRa
Product Related Impurities
dsRNA Immunoblota
Safety
Bacterial Endotoxin Endotoxin (LAL)
(Ph. Eur 2.6.14, USP <85>, JP 4.01)
Bioburden Bioburden
(Ph. Eur. 2.6.12, USP <61>, JP 4.05)
a. Assay not performed on stability.
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 = colony forming unit
090177e196ff3a96\Approved\Approved On: 10-May-2021 18:35 (GMT)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149293