Anyone responsible for the management of the supply chain to support a pharmaceutical or biologic clinical trial can appreciate the challenges associated with an unexpected or otherwise urgent need to produce clinical drug products. Many factors can conspire to make a rapid response to an urgent supply situation challenging. What measures then can a CMO take to help its clients respond when time is of the essence?
Current trends in drug development point toward a growing number of therapies that are targeting smaller patient populations. Rethinking aseptic filling from technology to process to service while meeting shifting market demands will help all participants in the pharmaceutical industry, and ultimately help the smaller patient populations who need targeted therapies.
A small, research-focused biotechnology company received incredibly positive results in the clinic for their current program and was instructed by leadership to push ahead quickly with an aseptic fill for another trial. They urgently needed help to get their finished drug product clinical supplies to their distributor by December to make it in the clinic by January 2020.
The advantages of contract manufacturing come with certain practical risks. Many of those risks are associated with inadequate communication and knowledge transfer between the drug’s originator and the CMO. This article approaches the subject from the perspective of a sterile drug product CMO and establishes methods to reduce project risks when moving from the laboratory to a GMP manufacturing setting.