Bao Cai

Company: Sarepta Therapeutics

Job title: Executive Director, Process Development

Seminars:

Ensuring Critical Quality Attributes (CQA) Consistency in Oligo Drug Development: Managing Analytical Considerations Through Drug Comparability 3:30 pm

• Regulatory agencies expectations for comparability assessments to manage changes  in the manufacturing process and ensuring CQAs are maintained through the product  development process • Analytical comparability of drug substances, methods that not only compare CQAs in  the release specifications but also conduct additional in-depth characterization and  impurity profiling • The importance of comparability assessments…Read more

day: Day Two PM