Cell and tissue starting materials for ATMPs
Cell & Gene Therapy Insights 2019; 5(12), 1621-1632.
The recent, rapid expansion in the use of cellular therapeutics has vastly increased the need to collect and process suitable starting materials from cell or tissue samples. These materials vary from relatively simple peripheral blood cell populations to the more complex tissue materials or established cell lines or isolates. In an evolving regulatory environment, adhering to good practice for acquisition, transport and processing is increasingly complex. Also, to understand the outcome of variations introduced during the manufacturing process and to permit more efficient process development, extensive analysis and retention of samples of the starting material is essential. However, these critical early steps are often overlooked and not optimized or standardized. In this article, we address some of the main challenges for the supply of high quality, consistent starting materials including: transport and hold time, cryopreservation, initial processing and the analysis of tissue and cellular materials. Variation in current practise highlights opportunities to standardize handling and testing of some common starting materials in order to increase consistency and quality control during the manufacture of these technically challenging advanced therapy medicinal products.