Sterility assurance in cell therapy products

Cellular therapy products represent a new wave in pharmaceuticals and include cellular immunotherapies, cancer vaccines and other types of both autologous and allogeneic cells for certain therapeutic indication. While the products are novel, sterility assurance concerns remain fundamental.

Topic areas we cover include:

• Sterility assurance principles
• Sterility testing
• Rapid microbiological methods
• Environmental monitoring
• Facility, equipment, raw materials, test system, and personnel
• Control of the collection, processing, packaging, and distribution of cell products

Dr. Tim Sandle has over twenty-five years’ experience of microbiological research and biopharmaceutical processing. He is a member of several editorial boards and he has written over six hundred book chapters, peer reviewed papers and technical articles relating to microbiology. Dr. Sandle works for a pharmaceutical manufacturer in the UK, and is a visiting tutor at both the University of Manchester and UCL.