Michael Leek, PhD, on Manufacturing Challenges in Cell Therapy


The co-founder and executive chairman of TC BioPharm discussed his thoughts on the regulatory, logistical, and quality hurdles of manufacturing cell therapies.

"If cell therapies became mainstream, and there were 20, 30, 40 cell therapies being worked on in every center of excellence, they can't all have different freeze-thaw processes. So there has to be a degree of unification going forward in how we ship product to the clinic, how we thaw the product to make sure it's still viable, and how we then get it into the patient, either through a drip or through direct injection. Those end point questions around delivery to the patient are really important and we haven't really fully addressed those yet."

As the cell therapy industry continues to grow, companies, organizations, and healthcare professionals continue to encounter challenges in the processes of manufacturing, shipping, and ultimate delivery to patients.

Michael Leek, PhD, co-founder and executive chairman of TC BioPharm, presented on the manufacturing challenges and regulatory, logistics, and quality hurdles in cell therapy development at the Onco Cell Therapy Summit (OCTS) USA 2022, held June 29-30 in Boston, Massachusetts.

CGTLive spoke with Leek to learn more about his insights from 35 years of experience in the cell therapy space. He emphasized the importance of having control over the manufaturing process and of developing universal standards for the industry, and discussed future potential applications for cell therapies as the field continues to advance.

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