- Overview of types of biologic products (therapeutic proteins, antibodies, drug-antibody conjugates, vaccines, gene therapies, cell-based therapies)
- Regulation of Biologics
- Establishing the TPP and QTPP and cross-functional product teams
- Clinical-phase-appropriate regulatory compliance in the development and establishment of manufacturing and control strategies for biologics and biosimilars. Each of the topics that follow will be discussed in depth from an early- and late-phase perspective of regulatory requirements. Early stage requirements will be emphasized on Day 1 and later phase on Day 2:
- Cell substrates & source materials, cell banks (storage, testing and other requirements)
- Upstream processing (preparation of media, fermentation, harvesting/recovery, critical process parameters)
- Downstream processing (purification strategies, process impurities, clearance studies)
- Final product formulation (stability issues, considerations in choosing storage temp)
- Characterization Testing
- Determination of CQAs
- Release and Stability Testing (Control Strategy)
- Setting Specifications
- Validation of analytical methods