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.

The liver performs multiple essential functions and owing to its remarkable regenerative capacity, serves as a key target organ for cell and organ transplantation as well as regenerative medicine. Due to well-known species differences in key hepatic functions, such as drug and lipid metabolism, between humans and experimental animals, in vivo models with humanized livers are regarded as highly valuable tools for investigating human liver biology. PhoenixBio has been producing highly humanized liver chimeric mice for over 20 years by xenotransplanting primary human hepatocytes derived from healthy donors into liver-injured, immunodeficient host mice (uPA/SCID). In this model, the majority of host mouse hepatocytes are replaced by transplanted human hepatocytes, achieving an average repopulation rate exceeding 80% within 3-4 months following cell injection. The transplanted human hepatocytes preserve their native human phenotypic features in the host mouse livers. Consequently, this mouse model has been widely utilized in various research areas, including drug screening and toxicology, human liver-specific infectious diseases (such as viral hepatitis), inherited metabolic disorders, and metabolic dysfunction-associated fatty liver disease (MAFLD). In this session, two speakers will present advances in research on liver biology and hepatocyte transplantation using humanized liver chimeric mice and freshly isolated human hepatocytes derived from them.