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Manufacture Advanced Medicine

CAR T Cell Therapy: Redefining Quality

Bethany Dudek is Executive Director, Quality Head Europe, Kite, USA

I have worked in quality for both traditional biotech and pharma companies (as well as in manufacturing and technology transfer), and I’ve found that there is often a disconnect between what quality does and what the other departments do – they’re seen as very separate parts of the business. With CAR T cell therapy, everything is connected and the role is much broader. For example, at Kite, I am responsible for all aspects of quality for the cell therapy products that we supply in Europe. My role spans QC release, qualifying the infusion centers that administer the product, various aspects of building the new manufacturing plant, various records and documents, as well as oversight of the distribution networks. This presents many challenges. When thinking about the quality journey of a CAR T cell therapy, the first and most obvious challenge is that each batch is autologous (specific to each patient). This means ensuring that the chain of custody is watertight from the moment the product leaves the patient to the moment it is reintroduced to the patient. 

Digitalization of this supply chain information can be a significant help from a quality perspective. We’ve created a patient portal for our products, which we use to track patient material and interface with our customers. This gives us oversight of the whole process. We understand how the chain links together and have identified key performance indicators that we check to ensure everything is happening as it should be along the supply chain. We also use qualified vendors to transport products from our approved hospitals to the manufacturing site. The infusion centers know how to receive the product, how to confirm that it has been shipped without issue and that they can receive it safely and prepare the patient for administration of our product. All of this is integrated into the patient portal, which interfaces with our internal IT system, allowing us to track everything along the way and react to anything unexpected.

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About the Author

Bethany Dudek

Executive Director, Quality Head Europe, Kite, USA

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