TOPICS TO BE COVERED:
1. Diverse modality of therapeutic biological products
2. Biologics CMC activities for regulatory filing (IMPD/IND)
3. Quality by design (QbD) concept, quality target product profile (QTPP), and critical quality attributes (CQA)
4. Cell line development, process development, and manufacture of biologics, CGT DS and DP
5. Current analytical technologies to characterize product variants/impurities, process impurities (e. g. HCP), and contaminants
6. Formulation development and compatibility with container closures and injection devices
7. Reference material characterization/qualification and justification of specifications for DS/DP release and ICH stability for product expiry
8. Process validation, analytical validation, and control strategy of cGMP manufacturing
9. Manufacturing process changes during product development lifecycle: CMC comparability exercise
WHO SHOULD ATTEND: The course is beneficial to individuals involved in biologics drug research/development, bioprocess development, analytical development, formulation development, quality control, quality assurance, regulatory affairs, project management, or related functional areas.