Document text
BNT162b2
3.2.A.2. Adventitious Agents Safety Evaluation [Andover ]
PFIZER CONFIDENTIAL
Page 1TABLE OF CONTENTS
LIST OF TABLES ................................ ................................ ................................ ..................... 1
3.2.A.2. ADVENTITIOU S AGENTS SAFETY EVAL UATION ................................ ............ 2
3.2.A.2.1. Introduction ................................ ................................ ................................ .....2
3.2.A.2.2. N on-Viral Adventitious Agents ................................ ................................ .......2
3.2.A.2.2.1. Raw Material Sourcing and Testing ................................ ................... 2
3.2.A.2.3. Conclusion ................................ ................................ ................................ .......6
LIST OF TABLES
Table 3.2.A.2-1. Materials of Animal Origin Used in the Manufacture of
Drug Substance ................................ ................................ ................................ .......4
090177e197035853\Approved\Approved On: 12-May-2021 07:25 (GMT)
FDA-CBER-2021-5683-1149019
BNT162b2
3.2.A.2. Adventitious Agents Safety Evaluation [Andover ]
PFIZER CONFIDENTIAL
Page 23.2.A.2. ADVENTITIOUS AGENTS SAFETY EVALUATION
Multiple mechanisms, procedures, and assay s are used to minimize the entry of adventitious
agents into the process stream and detect those agents that do enter the process stream. The
adventitious agent control program includes the
.
3.2.A.2.1. Introduction
The main theoretical risk associated with these ingredients is contamination of the product b y
Transmissible Spongiform Encephalopath y (TSE) agents. A multifaceted program exists to
ensure the viral safet y of the drug substance ,including
Management of transmissible spongiform encephalopathy (TSE) / bovine spongiform
encephalopath y (BSE) risks is part of the comprehensive adventitious agent control program
for BNT162b2 drug substance .
All raw materials used in the production of drug substance are evaluated as part of a
comprehensive program to identify and manage TSE/BSE risks. Under this program, the risk
of transmission of TSE/BSE from animal -derived materials is managed b y sourcing such
materials in a manner consistent with the current in dustry guidelines including those from the
European Medicines Agency (EMA), the Therapeutic Goods Administration (TGA), and the
World Health Organization (WHO).
The conclusion from the TSE/BSE risk evaluations performed for raw materials in the
BNT162b 2 process is that the risk of transmitting TSE/BSE via drug substance has been
minimized.
Details of any starting material , reagent or component containing material of animal origin
including its source and preparation are discussed in the following sections.
Moreover, equipment and materials are
according to validated procedures.
3.2.A.2.2. Non-Viral Adventitious Agents
3.2.A.2.2.1. Raw Material Sourcing and Testing
Raw material information is provided inSection 3.2.S.2.3 Control of Materials .
090177e197035853\Approved\Approved On: 12-May-2021 07:25 (GMT)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
(b) (4)
FDA-CBER-2021-5683-1149020
BNT162b2
3.2.A.2. Adventitious Agents Safety Evaluation [Andover ]
PFIZER CONFIDENTIAL
Page 3Information for animal -derived materials isprovided in Table 3.2.A.2-1 . All other materials
are of s ynthetic and/or biological origin.
090177e197035853\Approved\Approved On: 12-May-2021 07:25 (GMT)
FDA-CBER-2021-5683-1149021
BNT162b2
3.2.A.2. Adventitious Agents Safety Evaluation [Andover ]
PFIZER CONFIDENTIAL
Page 4Table 3.2.A.2 -1. Materials of Animal Origin Used in the Manufacture of Drug Substance
090177e197035853\Approved\Approved On: 12-May-2021 07:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149022
BNT162b2
3.2.A.2. Adventitious Agents Safety Evaluation [Andover ]
PFIZER CONFIDENTIAL
Page 5Table 3.2.A.2 -1. Materials of Animal Origin Used in the Manufacture of Drug Substance
090177e197035853\Approved\Approved On: 12-May-2021 07:25 (GMT)
(b) (4)
FDA-CBER-2021-5683-1149023
BNT162b2
3.2.A.2. Adventitious Agents Safety Evaluation [Andover ]
PFIZER CONFIDENTIAL
Page 63.2.A.2.3. Conclusion
In summary , a comprehensive, multifaceted program is in place to ensure that the risk, with
respect to potential viral and non -viral adventitious agent contamination of drug substance, is
acceptable.
090177e197035853\Approved\Approved On: 12-May-2021 07:25 (GMT)
FDA-CBER-2021-5683-1149024