Certificates of Analysis for Tissue Dissociation Enzymes: Practical Utility
Thursday, May 11th, 2023 | 11 AM ET
Enzyme suppliers provide Certificates of Analysis (CoAs) for each lot of product purchased by the customer. The primary enzyme manufacturer or the companies re-selling the manufacturer’s product use these CoAs to report the results of quality testing and acceptance criteria used to release the product for sale. The specification limits set internally by the manufacturer are guided by customer feedback or by internal decisions to ensure the majority of lots pass specifications. The topics addressed in this webinar are the practical utility of the CoAs when selecting a new lot of product; the correlation human islet isolation outcomes with CoA assay values; the use of CoAs for troubleshooting a failed islet isolation.
The webinar will review the assay results reported on CoAs from the three manufactures of enzymes for human islet isolation; identify the strengths and limitations of each assay to reflect the true function of collagenase to degrade native collagen; and provide recommendations for getting the most value from these documents.
About the Presenter
Bob McCarthy received a Ph.D. in immunology from Indiana University and did post-graduate training at the Mayo Clinic in Rochester, MN, on immunological research and development of clinical immunoassays. He joined Boehringer Mannheim Biochemicals in Indianapolis in 1987 as a Research Investigator and moved to Business Development and later Strategic Planning after the Roche acquisition of Boehringer Mannheim in 1998. In 1992, he led the R&D team that developed the Liberase HI Purified Enzyme Blend product to improve human islet recovery. In 2004, Francis Dwulet and Bob co-founded VitaCyte to improve the manufacture and characterization of collagenase and protease enzymes used for cell isolation and other biomedical applications. VitaCyte’s mission is to develop products that increase research productivity or improve clinical outcomes.