Raw materials and supplies for cell therapies: end to end expectations and best practices

Cell & Gene Therapy Insights 2024; 10(4), 513–524

DOI: 10.18609/cgti.2024.064

Published: 15 May
Expert Insight
Lili Belcastro

Ancillary materials are the raw materials and single-use systems that are used during the manufacturing of cell and gene therapies. Selecting, evaluating, and qualifying these materials require careful consideration. In this article, the aim is to provide readers with an overview of available guidance documents, best practices, and points to consider for raw material and supplier qualification from the point of view of a CAR-T drug product manufacturer.