Adapting to Fast-Emerging Medical Threats with Optimized Biotherapeutic Stability

SelectScience® spoke to Rebecca Gentile, Senior Specialist in Quality, Vaccine and Biological Stability at Merck,

Unlike chemical drugs, many biotherapeutics may be unstable due to their sensitivity to heat and light, as well as container materials or other components in the mixture. Ensuring long-term stability to optimize their therapeutic action is therefore an important part of vaccine development.

SelectScience spoke to Rebecca Gentile, a scientist at Merck, one of the largest companies involved in the commercial development of therapeutics, who is also giving a talk on 'Creating a Stability Budget to Support the Packaging and Distribution of Biological Products' at the 4th BioLogistics Summit in San Francisco, June 27-29.

Q: What are the current challenges in ensuring the stability of newly developed vaccines and biologics?

A: The products by default tend to not be particularly stable. Ensuring that the appropriate formulation and packaging is leveraged in the product design during development is a priority to being able to demonstrate appropriate stability for the commercial product. Designing stability studies to support the label storage condition and expiry, as well as supporting a stability budget for planned and unplanned time out of storage is important for managing the life cycle of the commercial product as well.

Q: What does the future hold for vaccine and biologics development?

A: I think faster design to meet emerging medical threats (Ebola, Zika virus) may become more common. Finding fast ways to optimize the program development will be critical, rather than leaving problems to be solved later after a first pass product is filed. Also, new platforms to establish more stable (possibly even room temperature) vaccines and biologics are intriguing and would enable improved delivery to more of the world’s population, especially in the developing world, as well as reduce shipping and storage cost and discard due to excursions.

Q: What new innovative projects or clinical trials have you been a part of and what are your day to day challenges?

A: Daily challenges include educating product teams as to the value of supporting the additional stability studies in Phase III development, prior to filing, to allow more flexibility to commercial product, as well as interpreting the stability data in a way that agencies will understand and accept.

Q: What other technology and products you would like to use in the future?

A: Development of lower cost shipping options for refrigerated products that maintain temperature ranges more reliably is always a benefit. Continuing to improve the design of the shippers themselves is beneficial in this area.

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