To help you speed up the time to initiate clinical trials, CBio can work with your team to develop a robust and efficient manufacturing and release process for your T-cell based therapiesincluding CAR-T, TCR and TILs.
All development work is performed according to GLP and cGMP standards in order to secure a state-of-the-art Chemistry, Manufacturing and Control (CMC) section for your regulatory filings.
As patients are enrolled in your clinical trials, CBio will secure timely delivery of high-quality named patient material in accordance with the agreed upon processes. After approval of your therapy, CBio can help assuring a smooth transfer to commercial scale manufacturing and delivery of products
Managing time, quality and cost is dritical for a good and efficient collaboration. CBio will work closely with your team to secure a good and efficient collaboration meeting and/or exceeding expectations
CBio will secure that all regulatory and clinical demands are met with appropriate documentation
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