By Bernat Busquet, Head of Project Management, and Maria Lloris, Head of R&D, UQUIFA
Drug companies seeking an advantage in today’s market must find ways to increase efficiency in R&D in order to retain profit margins while still maintaining a pursuit for innovative novel drugs. A common strategy for doing so is to turn to outsourcing, where they can work with a CDMO for the early phase development and manufacture of small molecule active pharmaceutical ingredients (APIs), which can help tremendously with reduced time and costs. Yet, while these CDMOs have attributes and qualities that make them exceptional for early phase work, they are not always equipped to support a drug program past Phase 2 when there is a considerable increase in scale to accommodate larger clinical trials. This requires a new partnership with a CDMO that can accommodate late-stage development, beginning with a tech transfer of the body of knowledge for a pharmaceutical product and process.
With time being of the essence, though, it is critical this transfer is executed properly to ensure optimal process reproducibility that preserves the intended quality, efficacy, and safety of a drug product. Any mistakes or setbacks could create costly delays in your path to market. So, how can you be sure the CDMO you select is prepared to successfully execute your tech transfer?