CAR-T Manufacturing Challenges and How to Overcome Them

The fast, demonstrable and curative effects that several approved CAR-T therapeutics have had over the past decade have excited the advanced therapies and oncology communities, encouraging rapid research and development. Since the approval of Kymriah by the FDA in August 2017 for the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse [1], there have been seven CAR-T therapies approved and marketed around the world, across eight indications.

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As with any advanced therapy, time and expenditure are critical to delivering CAR-T therapies. Often, patients awaiting CAR-T treatments do not have long before their condition can deteriorate [4], as CAR-T therapies are often reserved for patients for whom other treatment options may not have been successful. Lengthy vein-to-vein times – time between sample collection to patient delivery – can be problematic for patients with rapidly progressing conditions. Should there be a hold-up at any stage of the process, there is a risk that end-stage patients may lose the opportunity to benefit from the therapy itself.

In addition to timelines for patient delivery, commercialization timelines also have to be considered so that they resist buckling under pressure. The impact of bottlenecks with supply chains  satisfying regulatory requirements and optimizing the workflow itself can be detrimental to the success of a CAR-T therapeutic, and therefore careful consideration when addressing potential challenges that may arise, is crucial. As more CAR-T therapeutic opportunities approach critical regulatory stages, manufacturing processes come under increasing scrutiny, and areas for improvement emerge. 

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This article has been produced in partnership with WuXi Advanced Therapies.