Quality by Design— An Indispensable Approach to Accelerate Biopharmaceutical Product Development M. [...] Critical Quality Attributes and Ranges for a Glycoconjugate-Based Vaccine in Development: A Case Study 72 Section 2: Formulation Development 91 6. [...] Formulation and Product Development of a mAb1: A Case Study in Acceleration at Various Stages of Product Development 112 Section 3: Stability Modeling 131 8. [...] Comparability Assessment for Vaccines Development and Lifecycle 228 PART III: PROCESS UNDERSTANDING AND MODELING 238 Section 5: Process Understanding and Modeling 239 12. [...] Accelerating Product and Process Development Through a Model-Centric Approach 285 PART IV: ANALYTICAL STRATEGY AND MODELING 339 Section 6: Analytical Strategy and Modeling 340 15.
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- United States of America
