Course Description:
Understanding and controlling raw material variability requires a risk-based approach through the lens of deep technical experience and knowledge. For cell and gene therapies, the stakes have been raised significantly with more complex materials (including starting materials and biologic critical materials ), non-traditional suppliers, non-traditional supplier relationships, and DS/DP manufacturing processes that offer more limited (or certainly different) opportunities for control and risk mitigation for material variability. The talk will focus on opportunities, challenges, and differences with controlling raw material variability and starting materials variability for cell and gene therapy, with an emphasis on using material attributes, knowledge creation, and supplier collaboration as the foundation of risk-management and building a raw material control strategy.
The live version of this recording took place on April 16, 2021 and features
a presentation by Stefan Yohe, Ph.D.
Who should participate:
- Analytical chemists
- QA/QC analysts
- R&D scientists, managers
- Team members in CMC development projects
- Manufacturing scientists, managers
- Regulatory affairs specialists
- Contract research organizations
- Contract manufacturing organizations
Access Duration:Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.