125742 S2 M2 appendices adv agen safe val

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FDA-CBER-2021-5683-1148982
BNT162b2
2.3.A.2 Adventitious Agents Safety Evaluation
PFIZER CONFIDENTIAL
Page 22.3.A.2.2. Adventitious Agents Safety Evaluation [Kalamazoo]
2.3.A.2.2.1. Introduction
The main theoretical risk associated with these ingredients is a contamination of the product 
by Transmissible Spongiform Encephalopathy  (TSE) agents. A multifaceted program has 
been established to ensure the viral safet y of the drug product, including dev elopment of a 
formulation process that isdevoid of human or animal proteins
All raw materials used in the production of BNT162b2 are evaluated as part of a 
comprehensive program to identify  and manage TSE/BSE risks. The conclusion from the 
TSE/BSE risk evaluations performed for raw materials in the BNT162b2 process is that the 
risk of transmitting TSE/BSE via BNT162b2 has been minimized .
Details of an y material, reagent, or component containing material of animal origin including 
its source and preparation are discussed in 3.2.A.2. Adventitious Agents Safet y Evaluation 
[Kalamazoo]. These products are  
2.3.A.2.3. Non-Viral Adventitious Agents
2.3.A.2.3.1. Raw Material Sourcing and Testing
Raw material vendors are qualified to sourcing materials from them for use in the 
manufacturing process .  Raw material information is provided in 3.2.S.2.3 Control of 
Materials used in Manufacturing.
In particular, the human or animal -derived materia ls are provided in 3.2.A.2. Adventitious 
Agents Safet y Evaluation [Kalamazoo].  All other materials are of synthetic and/or biological 
origin .
2.3.A.2.3.2. Conclusion
In summary , a comprehensive, multifaceted program is in place to ensure that the risk, with 
respect to potential viral and non -viral adventitious agents contamination of drug product, is 
acceptable. Equipment is cleaned b y validated cleaning procedures described in 3.2.A.1 
Facilit y and Equipment – Kalamazoo. In addition, sterility  testing is performed on the final 
product, as descri bed in 3.2.P.5.1 Specifications.
090177e19700b11a\Approved\Approved On: 12-May-2021 07:22 (GMT)
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FDA-CBER-2021-5683-1148983
FDA-CBER-2021-5683-1148984