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.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
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