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By Joshua S. Katz

Joshua Katz-finalMany protein-based drugs and drug candidates have a limited shelf life or never reach the clinic due to thermal-mechanical instabilities in formulation. Improving the formulation stability of such pharmaceuticals will reduce costs and broaden markets for those drugs, while reducing side effects caused by byproducts of instability. Although improved thermal stability has been a holy grail of many large NGOs, most notably the Gates Foundation, simple technologies that offer even modest improvements to shelf life are still hard to come by. The main reason for the lack of innovation in this space is the significant regulatory hurdles associated with bringing new, non-API (active pharmaceutical ingredient) technologies to market. Indeed the process requires new technologies to come to market as part of a drug application, but rarely do these technologies come with the financial rewards associated with the new drug product itself. While there are lobbying efforts to bring better clarity and process to reduce the regulatory burden, until action is taken by FDA, little is expected to change, which significantly increases the barrier for innovation. For these reasons, excipient innovations currently target enabling technologies as there is little incentive to innovate incremental improvements.

Despite these challenges, my colleagues and I recently developed a surfactant excipient built from common, inert building blocks all of which have well-established safety records in biological applications. We believe this could be a facilitating material, possibly allowing challenging biologic compounds to make it to the patients in need of these treatments. Early studies have demonstrated that this surfactant slows the rate of thermally induced aggregation (one of the most common destabilization mechanisms) of therapeutically relevant proteins by a factor of two to three (depending on the protein) compared to the incumbent technologies.

Our poster on this work will be presented at the upcoming AAPS National Biotechnology Conference. We are currently evaluating multiple paths to bring this novel excipient to market including potential collaboration with pharma companies as well as evaluating the potential to utilize industry consortia aimed at bringing new material options to formulators of biologic systems.

Joshua Katz, Ph.D., is an associate scientist at The Dow Chemical Company. His research interests are materials for improved performance of heterogeneous, multi-component formulations; he can be reached at jskatz@dow.com.