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BNT162b2 3.2.P.5.2 Analytical Procedures Capillary Gel Electrophoresis PFIZER CONFIDENTIAL Page 13.2.P.5.2. CAPILLARY GEL ELECTROPHORESIS 090177e195572e5e\Approved\Approved On: 24-Oct-2020 04:54 (GMT) (b) (4) FDA-CBER-2021-5683-1149273
BNT162b2 3.2.P.8.1. Stability Summary and Conclusion PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 2 3.2.P.8.1. STABILITY SUMMARY AND CONCLUS ION ................................ .................... 3 3.2.P.8.1.1. Drug Product Shelf Life at Recommended Storage Temperature ................ 3 3.2.P.8.1.1.1. I n-use Period of Drug Product…
BNT162b2 3.2.P.8.3. Stability Data Thermal –Stress and Cycling PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 3.2.P.8.3. STABILITY DATA – THERMAL – STRESS AND CYCLING ............................ 3 LIST OF TABLES Table 3.2.P.8.3-1. Summary of Drug Product Thermal Stability Studies ................................ 4 Table 3.2.P.8.3-2. Stability Data for Drug…
BNT162b2 3.2.P.8.3 .Stability Data Photostability PFIZER CONFIDENTIAL Page 13.2.P.8.3. STABILITY DATA – P HOTOSTABILITY Data from one stability study on a BNT162b2 process validation drug product subjected to ICH photostability conditions is presented. Drug product vials were exposed to a light source that provides an overall illumination of not less than 1.2 million lux hours and an integrated ultraviolet energy of not less than 200 watt hours/m2, per I CH Q1B. Dark control vials w ere…
BNT162b2 3.2.P.8.3 Stability Data Long Term PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 3.2.P.8.3. STABILITY DATA - LONG TERM ................................ ................................ ........ 3 LIST OF TABLES Table 3.2.P.8.3-1. Summary Table of Drug Product L ong Term Stability Studies ................. 4 Table 3.2.P.8.3-2. Stability Data for…
BNT162b2 3.2.P.8.3. Stability Data Accelerated TABLE OF CON TENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 3.2.P.8.3. STABILITY DATA – ACCEL ERATED ................................ ................................ ..4 LIST OF TABLES Table 3.2.P.8.3-1. Summary Table of Drug Product Accelerated Stability Studies ................ 5 Table 3.2.P.8.3-2. Stability Data for Drug Product EN6199 Stored at…
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 …
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) (b) (4) 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…
BNT162b2 3.2.P.5.4. Batch Analyses PFIZER CONFIDENTIAL Page 1TABLE OF CONTENTS LIST OF TABLES ................................ ................................ ................................ ..................... 1 3.2.P.5.4. BATCH ANA LYSES ................................ ................................ ................................ 3 LIST OF TABLES Table 3.2.P.5.4-1. Summary of BNT162b2 Drug Product Lots ................................ ............... 4 Table 3.2.P.5.4-2. Batch Anal…
BNT162b2 3.2.P.4 .6 Novel Excipients (Non -Com pendial) PFIZER CONFIDENTIAL Page 13.2.P.4.6. NOVEL EXCIPIENTS (NON -COMPENDIAL) The two novel lipid excipients used in the BNT162b2 drug product manufacturing are ALC-0159 (2 -[(poly ethylene glycol) -2000]- N,N-ditetradecy lacetamide) and ALC-0315 ((4-hydroxybutyl)azanediy l)bis(hexane -6,1-di yl)bis(2 -hexyldecanoate)). Additional information is provided in Section 3.2.A.3 Excipients [ALC-015 9] and Section 3 .2.A.3 Excipients [ALC-0315] ,…
BNT162b2 3.2.P.4 .5 Excipients of Human or Animal Origin PFIZER CONFIDENTIAL Page 13.2.P.4.5. EXCIPIENTS OF HUMAN OR ANIMAL ORIGIN There are no excipients of human or animal origin used in the manufacture of BNT162b2 drug product . 090177e195573da2\Approved\Approved On: 24-Oct-2020 06:17 (GMT) FDA-CBER-2021-5683-1149045
BNT162b2 3.2.P.3.1. Manufacturer(s) PFIZER CONFIDENTIAL Page 13.2.P.3.1. MANUFACTURER(S) Table 3.2.P.3.1-1 lists the sites that have responsibilities in the production of BNT162b2 drug product and their specified functions. Table 3.2.P.3.1 -1. Sites and Responsibilities for BNT 162b2 Drug Product Manufacture Site FEI / DUNS Numbers Responsibility Pharm acia & Upjohn Company LLCc 7000 Portage Road Kalamazoo, MI 49001 United StatesFEI: 1810189 DUNS: 618054084LNP production and bulk drug …
BNT162b2 3.2.S.4.3 Validation of Analytical Procedures Overvie w PFIZER CONFIDENTIAL Page 13.2.S.4.3. OVERVIEW Validation of anal ytical procedures was performed to ensure the composition, strength, identity , purity , and safety of BNT162b2 drug substance . All non- compendial and compendial anal ytical procedures were confirmed suitable for their intended use. 090177e19700b47a\Approved\Approved On: 12-May-2021 07:48 (GMT) (b) (4) FDA-CBER-2021-5683-1149294
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)…
BNT162b2 3.2.P.3.4 Control of Critical Steps and Intermediates In-Process Monitoring and Control –Overview PFIZER CONFIDENTIAL Page 13.2.P.3.4. IN-PROCESS MONITORIN G AND CONTROL –OVERVIEW This section provides a description of the controls of critical steps employ ed during manufacture of BNT162b2 d rug product to ensure that product qualit y and integrit y are maintained. Process parameters andin-process tests that are used to control the process and drug product qualit y are provided in…
BNT162b2 3.2.P.2 Pharmaceutical Development Introduction PFIZER CONFIDENTIAL Page 13.2.P.2. PHARMACEUTICAL DEVEL OPMENT –INTRODUCTION In this section, the formulation and process development and control strategy for BNT162b2 drug product are described. The pharmaceutical development of BNT162b2 The pharmaceutical development section for drug product is organized as follows: 1. Components of the Drug Product The components of the drug product including physicochemical characteristics of…
BNT162b2 3.2.P.1 Description and Composition of the Drug Product PFIZER CONFIDENTIAL Page 13.2.P.1. DESCRIPTION AND COMPOSITION OF THE DRUG PRODUCT The BNT162b 2 drug product issupplied as a preservative -free, multi- dose concentrate to be diluted for intramuscular injection , containing 6 doses. The drug product is a sterile dispersion of RNA -containing lipid nanoparticles (LNPs ) in aqueous cry oprotectant buffer . Each vial, containing 0.45 mL of the drug product at pH 7.4 is designed…
BNT162b2 3.2.A.3.1.2 Structure [ALC -0315] PFIZER CONFIDENTIAL Page 13.2.A.3.1.2. STRUCTURE [ALC -0315] 3.2.A.3.1.2.1. Chemical Structure The AL C-0315 novel excipient is a cationic lipid containing a tertiary amine and two ester moieties. The chemical structure is shown in Figure 3.2.A.3.1.2-1. Figure 3.2.A.3.1.2-1.Chemical Structure of ALC -0315 Asteri sks(*)indicate chiral centers . 3.2.A.3.1.2.2. Molecular Formula The molecular formula ofALC-0315 is C 48H95NO 5. 3.2.A.3.1.2.3.…
BNT162b2 3.2.A.3.1.2 Structure [ALC -0159] PFIZER CONFIDENTIAL Page 13.2.A.3.1.2. STRUCTURE [ALC -0159] 3.2.A.3.1.2.1. Chemical Structure The chemical structure of AL C-0159 is shown in Figure 3.2.A.3.1.2 -1. Figure 3.2.A.3.1.2-1. Chemical Structure of ALC -0159 3.2.A.3.1.2.2. Molecular Formula The molecular formula is (C2H4O)nC31H63NO 2. 3.2.A.3.1.2.3. Molecular Weight The molecular weight is approximately 2100-2700 Dalton s. The range is due to the polydispersit y of the PEG polymer…
BNT162b2 3.2.A.3.1.1 Nomenclature [ALC -0315] PFIZER CONFIDENTIAL Page 13.2.A.3.1.1. NOMENCLATURE [ALC -0315] Information on the nomenclature of AL C-0315 is provided in Table 3.2.A.3.1.1-1. Table 3.2.A.3.1.1-1. Nomenclature of ALC -0315 Nam e/code Description Company or Laboratory Code ALC -0315 IUPAC Chemical Name [(4-Hydroxybutyl)azanediyl]di(hexane -6,1- diyl) bis(2- hexyldecanoate) Chemical Abstract Service Chemical NameDecanoic acid , 2-hexyl -, 1,1’ -[[(4-hydroxybutyl)imino]di -…