Thursday, December 11, 2025 | 11 AM ET
Presented by
Robert McCarthy, PhD
Two published Standards on ancillary materials (AMs) are the US Pharmacopeia (USP) <1043> and ISO 20399 International Standard. The ISO Standard defines AMs as “materials that come in contact with the cellular therapeutic product during cell processing but are not intended to be part of the final product formulation.” This Standard outlines the requirements that the AM manufacturer should meet to qualify as a supplier. The AM supplier is responsible for controlling, documenting, and communicating the known aspects of the AM manufacturing process that affect product quality and consistency. VitaCyte has designed manufacturing processes and product testing that align with the criteria that impact AM performance for the intended application. A case study will be presented demonstrating how the biochemical characteristics of collagenase enzymes affected human islet yields, leading to fewer islet transplants in 2007 as part of the Clinical Islet Transplantation Consortium clinical trial.
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Meet the Presenter
Robert McCarthy, PhD
VitaCyte, President & Co-Founder
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.