Cold Chain, Hot Topic: Cell Therapy and Biopharmaceutical Distribution.

The Challenge and Opportunity of Cell Therapy and Biopharmaceutical Distribution with Rachel Griffiths, Samantha James, and Rich Nelson

Sensitive cell therapy and biopharmaceutical distribution is a complex challenge that calls for detailed understanding of the product, access to the latest technologies, and global reach combined with local knowledge.

Pharmaceutical industry interest in biopharmaceuticals, cell therapies and, more recently, biosimilars has increased significantly. In addition to targeting and treating disease more effectively than small molecule medicines, such products have the potential to generate higher revenues and are less likely to face competition when they go off patent.

However, unlike small molecule drugs, which can be easily trans-ported, large molecule biopharmaceuticals are highly sensitive to temperature fluctuations and require special handling. Large molecule drugs are also more expensive to develop and manu-facture than small molecule products, which means any lost as a result of problems during transportation have a higher financial impact.

Similarly, transporting cell therapies is a challenge. While hydrogel-based alternative technologies are being developed, the vast majority of cell therapies are still shipped as frozen stocks.

Failure to protect frozen cells against temperature fluctuations can be disastrous, particularly for autologous therapies derived from cells extracted from the patient.

Effective Cold Chain Cell and Biopharmaceutical distribution requires knowledge of the product being transported. Everything from the physical charac-teristics of the molecule or cell and the temperature range over which it is stable to how it is packaged must be understood. The various touch points within the manufacturing, packaging, and distribution network also warrant considerable understanding to maximize the effectiveness of the successful end-to-end Cold Chain.

But beyond the product, other factors also need to be considered. Choosing the correct container and monitoring technology is vital, as is knowledge of the environmental conditions and customs procedures used at the destination. A detailed understanding of the regulatory requirements is criti-cal, as is having a courier network capable of ensuring the safe transportation of such high value shipments.

Rachel Griffiths, Samantha James, and Rich Nelson explore the unique challenges and opportunities of Cell Therapy and Biopharmaceutical Distribution.

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    PCI offers over 30 years’ experience in the storage and distribution of clinical trial materials, effectively storing and distributing thousands of patient kits to over 100 countries world-wide.

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