How to effectively manage critical raw materials to support clinical development in CAR-T cell therapy

Published: 28 March 2019
Emilie Gauthy,
Emilie Gauthy
Industrialization Manager
Emilie Gauthy is Industrialization Manager at Celyad Oncology and a Bioengineer by training with a PhD in immunology. In her role at Celyad, Emilie oversees CMOs & CROs work and acts as the Raw and Starting Materials Site Matter Expert in the context of autologous and allogeneic CAR-T manufacturing.
Laure Lambricht,
Laure Lambricht
QA Associate at Celyad SA
Sarah Snykers
Sarah Snykers
QC Manager at Celyad SA
Sarah is Director of the Cell Therapy Manufacturing Unit at Celyad, a clinical-stage biotechnology company focused on the discovery and development of chimeric antigen receptor T cell (CAR T) therapies for cancer. She has over 10 years of experience in cell therapy, biomedical research, development and quality control.She is a pharmacist from education and has a PhD in pharmaceutical and biomedical sciences, specialised in stem cell biology. In 2010, she joined Promethera BioSciences, a biopharmaceutical company dedicated to the development of cell therapy products based on allogeneic adult stem cell technology to treat liver diseases. She headed the R&D, QC and Preclinical Departments. In 2015, she joined Celyad. Sarah initially led the immune-oncology program at R&D level, focused on technology transfer, product characterization and optimization. In 2016, she became Head of the QC Department, covering release of clinical products and raw material, analytical method development and translational research activities. In 2020, all operational activities including Production, QC, Validation and Tech transfer of processes, methods, equipment, raw material and viral vector became under her responsibility.

In CAR-T cell therapy, one of the main challenges to obtaining a consistent, reproducible manufacturing process and therapeutic product is the variation of the cellular starting material. However, one should not overlook the importance of raw materials. Proper selection and control of raw materials and their suppliers/manufacturers are critical moving forward during clinical development. It will impact process and product quality, safety, consistency, but also support continuous manufacturing and cost of goods control. In this opinion piece, we describe based on our experience a practical and effective risk-based tool to prioritize effort towards raw materials during clinical development. This approach should help identifying weaknesses and establish an action plan to prepare for commercial raw material readiness.

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