This course covers:
*Background on raw materials as a critical component of good manufacturing practices
*Types of raw materials
– Starting materials for biotechnology-based manufacturing
– Materials used during purification and downstream manufacturing
– Critical raw materials for analytical testing and assays used for release and stability testing
*Considerations for quality control of raw materials (compendial and non-compendial)
– Including case studies: (1) animal-derived raw materials, (2) leachables from containers or tubing raw materials
*Changes to raw materials used in a licensed product and examples of types of filings required based on potential impact to product quality

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