Successfully Managing The Unique Demands Of Cell Therapy Supply Chains

By Rachel Griffiths, Associate Director, Technical Services, PCI Clinical Services and Dr. Matthew Lakelin, Vice President, Scientific Affairs and Business Development, TrakCel

The cell therapy industry is advancing at significant pace with these novel therapies providing curative treatments to patients who previously had little hope of survival. The complexity associated with manufacturing a ‘living drug’ should not be underestimated and it is important to consider that although some general principles can be applied to cell therapies, each product will have its own specific challenges and complexities for managing its generation, manufacture and delivery.

There is a panoply of technical and scientific challenges associated with cell therapies but the patient’s wellbeing should always be at the centre of the decision-making process throughout the product’s development lifecycle. However, such is the technical complexity of the treatment process that the supply chain and manufacturing model may encounter risks which need to be addressed and actively managed to ensure consistent quality of product and safe treatment of patients.

To manage these risks, a robust understanding of the full cell therapy process and the consequences of out-of-scope activities is required. Identifying these consequences is not something which should be done in isolation; a multidisciplinary approach is required, involving all stakeholders – treating physicians, manufacturing experts and developmental scientists. Together these risks can be quantified and adequate mitigation steps developed to successfully manage the complex supply of these cell therapy products that may be difficult to manufacture and manage, but are so key to patient outcomes.

While cell therapy is playing an increasingly important role in the treatment of a variety of conditions, the real challenge in delivering it successfully is not necessarily in the manufacturing protocol alone, but in the administration and co-ordination of the complex supply chain as a whole. Therefore supply chain risk management (SCRM) becomes an essential part of the process. Risks associated with production and transportation need to be assessed in advance and formulated into a robust risk assessment strategy.

The efficient management (see image above) of both the incoming apheresis units and the final product is imperative due to their short shelf-life. An effective risk strategy needs to be employed to manage the chain from collection of cells through production to a final product and back to the patient.

A thorough and robust risk assessment can influence the approach in managing the cell therapy supply chain and help to identify which factors in that chain might in turn influence manufacturing decisions. Factors to be taken into account might include, for example, the decision as to whether to have centralised or localised manufacturing strategies; whether the planned supply chain is logistically feasible; any import and export requirements; and of course time scales.