Quality control testing in CAR-T cell manufacture

July 23, 2018

Sagentia recently sponsored the Cell and Gene Therapy Strategy Meeting, held in Boston on 12th June 2018. Rob Morgan, VP Medical, chaired a round table discussion of quality control testing in CAR-T manufacturing focused on current challenges, the changing needs of emerging therapies and opportunities for the adoption of new technology.

A clear roadmap for the production and testing of CAR-T therapies will be vital for the stakeholders engaged in the delivery of these exciting new therapies in order to realize their full potential for patients.

CAR-T therapies are complex biological materials and because they are autologous they are inherently variable due to differences in sampled patient cell populations and their responses to processing. The production process is complex, requires high levels of operator skill and involves complex biological materials, not least the viral vectors used in genetic modification. Consequently, during the assessment of these therapies in the clinic, regulators have required an array of release tests to be performed on each single lot, single patient therapy. These release tests are required in order to show satisfactory identity, safety, purity and potency. CAR-T therapies have been shown to be highly effective in certain patient populations but also to have significant side effects, for example cytokine release syndrome, so the high burden of testing is understandable.

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