GABRIELA SILVIA MEZOÑA (asker) Mar 5, 2023:

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TABLE OF CONTENTS
LIST OF FIGURES
1 RUBELLA STOCK SEED MANUFACTURED WITH FETAL BOVINE
SERUM
2 DESCRIPTION OF CHANGE
2.1 Manufacturing Process Changes
2.1.1 Current Process
2.1.2 Proposed Rubella Stock Seed Process
2.1.3 BSE/TSE and Adventitious Agents Analysis for Replacement of HAS with FBS in Rubella Stock Seed Manufacturing
2.2 Analytical Methods Supporting the Rubella Stock Seed with FBS
3 ANALYTICAL COMPARABILITY STRATEGY AND SUMMARY OF CONCLUSIONS FOR RUBELLA STOCK SEED WITH FBS
3.1 Introduction
3.2 Manufacture of Demonstration Lots
3.3 Analytical Comparability Methods, Acceptance Criteria, and Results
3.4 Detailed Analytical Comparability Results
3.4.1 Infectivity Titration (Potency) for Rubella Stock Seed Lot 0000699461
3.4.2 Infectivity Titration (Potency) for Rubella Drug Substance HVF
3.4.3 Infectivity Titration (Potency) for Stock Seed Potency, taken during Rubella Drug Substance HVF
3.4.4 Western Blotting for Rubella Surface Proteins
3.4.5 Infectivity Titration (Potency) for Rubella Drug Substance Pre-clarified Bulk
3.4.6 Infectivity Titration (Potency) for Rubella Drug Substance