In-house manufacture of plasma-derived human AB serum for use in cellular therapeutics.

Abstract

Successful manufacture of cellular therapeutic products requires a medium containing key nutrients to support cell expansion. Some of the most common supplements to cell culture media include serum products such as fetal bovine serum, human serum albumin, and human AB serum. Medium supplementation with human AB serum provides critical growth factors, lipids, proteins, and hormones without the risk of cross-species antigenicity or anti-AB antibodies. In this report, we describe the use of pooled defibrinated plasma, sourced from a US blood bank, to produce serum in-house that complies with blood product, cell therapy, and current Good Manufacturing Practice (cGMP) regulations. We are currently using this product as a culture supplement for the in-house manufacture of chimeric antigen receptor T cell (CAR-T) and tumor-infiltrating lymphocyte (TIL) therapeutics under IND. Our current validated clinical laboratory procedure is included as supplementary material.