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BNT162b2
3.2.P.5.1 Specification(s)
PFIZER CONFIDENTIAL
Page 13.2.P.5.1. SPECIFICATION(S)
The specification for BNT 162b2 drug product at release and throughout shelf life is provided
in Table 3.2.P.5.1-1. For all quality attributes
.
090177e19703582d\Approved\Approved On: 12-May-2021 07:26 (GMT)
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FDA-CBER-2021-5683-1149102
BNT162b2
3.2.P.5.1 Specification(s)
PFIZER CONFIDENTIAL
Page 2Table 3.2.P.5.1 -1. BNT162b2 Drug Product Specification
Quality Attribute Analytical ProcedureaAcceptance Criteria
Composition and Strength
Appearance Appearance (V isual) White to off -white suspension
Appearance (Visible
Particulates)Appearance (Particles)
(Ph Eur. 2.9.20, USP <790> , JP 6.06)May contain white to off -white opaque,
amorphous particles
Subvisible Part icles Subvisible Particulate Matter
(USP <787>, l ight obscuration method)
pH
(Ph. Eur. 2.2.3, USP <791>)6.9 –7.9
Osmolality Osmometryb,c
(USP <785>)
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
Vial content (volume) Container contentc Not less than
Identity
Lipid identities HPLC -CADcRetention times consistent with references
(ALC -0315, ALC -0159, Cholesterol,
DSPC)
Identity of encoded
RNA sequenceRT-PCRcIdentity confirmed
Potency
In Vitro Expression Cell-based f low cytometry
Purity
RNA Integrity Capillary Gel Electrophoresis
Adventitious Agents
Bacterial Endotoxin Endotoxin (LAL)
(Ph. Eur. 2.6.14, USP <85>, JP 4.01)
Sterility Sterilitye
(Ph. Eur. 2.6.1, USP <71>, JP 4.06)No Growth Detected
Container Closure
IntegrityPass
a. All assays performed on stability unless otherwise noted.
b. In accordance w ith Ph. Eur. 2.2.35, w ith minor difference in instrument calibration
c. Assay not performed on stability.
d. Acceptance criteria values reflect viscosity correction. See Section 3 .2 P.5.6.8 for detailed explanation.
e.
.
Abbreviations: LNP = Lipid nanoparticles; CAD = charged aerosol detector; RT -PCR = reverse transcription
polymerase chain reaction; FACS = fluorescence activated cell sorter; ddPCR = droplet digital PCR; qPCR =
quan titative PCR; dsRNA = double stranded RNA; LAL = Limulus amebocyte lysate; EU = endotoxin unit
090177e19703582d\Approved\Approved On: 12-May-2021 07:26 (GMT)
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FDA-CBER-2021-5683-1149103