World Cancer Day: Standardising T-cell therapies

04 February 2020

Today is World Cancer Day. Written into the Charter of Paris Against Cancer on 4 February 2000, the day offers an opportunity to consider developments that have taken place to better understand and treat cancer.  

4 February 2020

Marking World Cancer Day, we look at research published in SCI’s Journal of Chemical Technology and Biotechnology.

Chimeric Antigen Receptor T-Cell (CAR-T) therapies are novel cancer treatments that can provide therapeutic options for oncology areas with high unmet medical needs. CAR-T therapy is a type of treatment in which a patient’s T-cells are altered in the laboratory so that they will attack cancer cells.

FDA approvals have been given for two CAR-T therapies. One is for treatment of relapsed or refractory B-cell acute lymphoblastic leukaemia and the other for aggressive non-Hodgkin lymphoma. CAR-T therapies targeting other haematologic tumours associated with antigens are also in late stage clinical development.

The accelerated approval of the therapy is encouraging and underscores the potential for this novel technology platform. However, these powerful ‘living drugs’ are very different to conventional small molecule and biologic therapies. The highly complex nature and varied composition of CAR-T based products still requires considerable investigation to resolve the best approaches to ensure reproducible and cost-effective manufacture.

Researchers conclude that while two CAR-T based products have been approved, wider patient access and development of CAR-T therapies for more common cancer types is a priority.

The development of more closed and automated production units has been a major advancement for manufacturing, but GMP compliant manufacture is inherently challenging due to the emerging regulatory environment. Release testing for each lot is onerous and setting manufacturing criteria is complicated in many instances because of an incomplete understanding of the product’s mechanism of action. This means that standardisation is inherently difficult but should be an essential component if appropriately designed.

Journal of Chemical Technology and Biotechnology


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