Course Description:
This four-hour course will provide International Council for Harmonization , World Health Organization, and USP guidelines related to cell banking and characterization. Key cell banking concepts and usage will be covered including good manufacturing practices, preparation, and process flow. The course content applies to cell substrate for a recombinantly engineered biological product along with some vaccine-specific content. Participants will be engaged in practical exercises and Q&As to reinforce learning. Participants will better understand suitable development, cloning, and characterization of cell banks for the production of vaccines and other biologics as critical components for the licensure and consistency of these products.
The live version of this recording took place on May 2021
Upon completion of this course, you will be able to
- Explain cell banking
- Describe cell banking in terms of ICH guidelines and USP general chapters
- Explain the identification, qualification, and selection of primary cells
- Summarize the rationale for the analysis of cell construct
- Describe the most critical elements of the cell history that must be documented
- Summarize the characterization of cells and cell banks
- Describe storage, controls, and logistics as it pertains to cell banking
Who should participate:
- R&D Cell Biologists
- R&D Manufacturers
- Research Scientists
- Biotechnology Manufacturers
- Pharmaceutical Microbiologists
Access Duration:
Access to this course expires 60 days from the date of registration or until you mark the course ‘Complete’ – whichever occurs first.
USP Approved Instructor
Victor Maqueda
USP Consultant
Biologist/Professor of Biological Sciences
Maura C. Kibbey
USP Staff
Senior Scientific Fellow, Global Biologics