StemCell Therapy

MOH approves Cocoon Platform to manufacture a CD19 CAR-T cell immunotherapy for Phase II clinical trial for B-cell malignancies.

Contract Pharma Staff09.09.20

Lonza and Sheba Medical Center announced the first patient has been treated at Sheba Medical Center with a CD19 CAR-T cell immunotherapy manufactured using Lonzas Cocoon Platform. The Cocoon Platform is an automated and functionally closed system for patient-scale cell therapy manufacturing, designed to overcome some of the manufacturing challenges of manually producing personalized medicines, including autologous CAR-T cell therapies.

Sheba Medical Center and Lonza have collaborated to translate Shebas open, manual manufacturing process into the Cocoon Platform since mid-2019. Teams from Lonza Personalized Medicine and Collaborative Innovation Center (CIC) in Haifa, IL worked closely with Sheba Medical Center to complete process development, tech transfer, training and a full clinical comparability study requiring regulatory approval before the first patient could be treated. The approval of the Cocoon Platform clinical comparability study illustrates the platforms flexibility and ability to manufacture a final cell immunotherapy which is comparable to the original manual process while meeting the extensive patient safety criteria.

Sheba and Lonza plan to treat additional patients under the same CD19 CAR-T cell immunotherapy protocol using the Cocoon Platform. The Cocoon Platform will enable Sheba to reduce immunotherapy manufacturing costs by lowering manpower, time, and space requirements. The goal is to ultimately allow Sheba to deliver potentially curative cellular immunotherapies to more patients.

See the article here:
CD19 CAR-T Therapy Manufactured Using Lonza's Cocoon Platform - Contract Pharma

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