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Jan 15, 2009 (Vol. 29, No. 2)

Identifying Best Practices for Advanced Therapies

U.K. Knowledge Transfer Network Initiates Dialogue on New Product R&D

  • Aesthetics and Utility

    Intercytex, a U.K.-based cell therapy company, has a number of products in development based upon allogeneic fibroblasts and autologous dermal papilla cells. The company and its products are governed by the rules of the European Human Tissue Directive and licensed by the Human Tissue Authority. It is through this route that the company has been able to progress Vavelta® to the marketplace in the U.K.  

    Vavelta is a skin repair and regeneration therapy developed specifically to treat skin damaged by scarring (e.g., acne scars) or the aging process. “With Vavelta, we are creating a working model for our cell-based products for the future,” said John Lovelady, Ph.D., vp, operations. Intercytex has also completed Phase III trials with Cyzact® for venous leg ulcers. Icx-Skna, a skin-replacement product, is also being evaluated.

    These products are temperature sensitive, with a shelf life of 2–21 days, which creates challenges for both packaging and transportation. “Their efficacy depends upon being a living product,” Dr. Lovelady added.

    Vavelta is currently distributed to a select number of highly qualified clinics in the U.K. “It must arrive in the best possible condition, and the clinic must understand and comply with the storage requirements on receipt. We are using packaging befitting the high-quality status of the product, which is independent of the clinic destination and the courier.”

    Intercytex is currently using NanoCool™ packaging, which can generate and maintain a cold temperature, is self-contained, and independent of external temperature and transport method, as well as being easy to use. The cells are also stored in a hypothermic solution.

    “We are committed to ensuring that all elements of the development program, including shipping, are such that we can deliver the product to the clinic in perfect condition—an expensive undertaking,” pointed out Dr. Lovelady. Aesthetics and utility go hand-in-hand to create a high-quality brand that supports this new technology.

    A further challenge for cell-based products is loss of cell viability during transportation, caused by a build-up of toxic components as a result of natural processes of the living cells, e.g., apoptosis or metabolic activity. This is linked to storage conditions as cycling of temperature is particularly detrimental to cell viability.

    Dr. Lovelady also believes that there should be a clear definition of when a cell-based product is no longer usable. “In the early stages of cell therapy, there is likely to be a lot of waste. However, this will get better with time and experience. In recent months with Vavelta, we have been able to provide a reasonable shelf life, facilitating easier treatment planning in the clinic,” he commented.

    As the business expands, Intercytex is considering how it will go global. Once the product is formulated, the clock is ticking. “To facilitate worldwide distribution,” explained Dr. Lovelady, “we may consider manufacturing in the country of use to shorten the supply chain.”

    Distributors would need to be able to guarantee delivery and demonstrate full traceability just as the parent organization does. This is indeed a challenge, but a positive step to take as cell therapies could become mainstream in the future.

    Packaging of a cell-therapy product must also be able to cope with the range of production—from small scale to bulk orders—and take into account that even something as simple as orientation of the product within the packaging could be crucial.

    Finally, cryoprotectants and cryopreservation issues may also be important for the future; how the product would be resuscitated, and the biocompatibility of the solutions are challenges yet to be solved.


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