125742 S2 M3 32p8 postapproval stability

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BNT162b2
3.2.P.8.2 .Post-Approval Stabilit y Protocol and Stability Commitment
PFIZER CONFIDENTIAL
Page 13.2.P.8.2. POST -APPROVAL STABILITY PR OTOCOL AND STABILITY
COMMITMENT
The commercial shelf life of the drug product will be established based on the I CH stability  
studies that are being carried out per protocols detailed in Section 3.2.P.8.1 Stability  
Summary  and Conclusions.
Post-approval, a minimum of one lot of BNT162b2 drug product will be enrolled in the 
commercial stability  program at the long term storage condition of - 90 to -60 C each year 
thatdrug product is manufactured. The protocol is provided in Table 3.2.P.8.2-1 for the long 
term storage conditions of -90 to -60C.
Table 3.2.P.8.2 -1.Post-Approval Commercial Stability Protocol for Drug Product 
Stored at -90 to -60 °C
Analytical Procedure/ Quality Attribute Test Intervals (Months)a
Appearance (Visible) 0, 6, 12 , 18, 24
Appearance (Visible Particulates)
pH
Subvisible Particulate Matter
Dynamic Light Scattering (DLS) LNP Size
LNP Polydispersity
Fluorescense Assay RNA Encapsulation
RNA Content
HPLC -CAD ALC -0315 Content
ALC -0159Content
DSPC Content
Cholesterol Content
Cell-based Flow  Cytom etry In Vitro Expression
Capillary Gel Electrophoresis RNA Integrity
Container Closure Integrity Test Annually through end of shelf life
Sterility 0, End of shelf life
Endotoxin
a.Additional test intervals may be included for the purpose of extending expiry.
Abbreviations: LNP = Lipid Nanoparticle
090177e195573c1b\Approved\Approved On: 24-Oct-2020 06:52 (GMT)
FDA-CBER-2021-5683-1149104