Ensuring Critical Quality Attributes (CQA) Consistency in Oligo Drug Development: Managing Analytical Considerations Through Drug Comparability
Time: 3:30 pm
day: Day Two PM
Details:
• 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 that include representative batches
before and after process modifications, along with toxicology batches
