Cold Chain Complexities Of Distributing Temperature-Sensitive Biopharmaceuticals And Cell Therapies
Distributing sensitive biopharmaceuticals and cell therapies 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 transported, large molecule biopharmaceuticals are highly sensitive to temperature fluctuations and require special handling.
Large molecule drugs are also more expensive to develop and manufacture 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 distribution requires knowledge of the product being transported. Everything from the physical characteristics 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 critical, as is having a courier network capable of ensuring the safe transportation of such high value shipments.
Source: Pharmaceutical Online