VitaCyte is sponsoring a Symposia.
ISO 20399 Standard for Ancillary Materials:
Relevance to Tissue Dissociation Enzymes
Robert McCarthy
Thursday, October 23 | 12:30-13:30
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 the AM manufacturer should conform to for qualification as a supplier. The AM supplier is responsible for controlling, documenting, and communicating known aspects of the AM manufacturing process that impact the quality and consistency of the product. 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 that demonstrates how the biochemical characteristics of collagenase enzymes affected human islet yields, leading to fewer islet transplants being performed in 2007 as part of the Clinical Islet Transplantation Consortium clinical trial.