By Dr. Kashif Ghaffar, Pharmacist for Process Validation, Pfizer CentreOne
During early drug development there is a tendency to adopt a ‘fit-for-purpose’ strategy when producing formulations for clinical trials. This approach is understandable considering that only one in ten compounds that enter clinical trials will become registered products. Nevertheless, it is important to build in robustness for manufacture early in development and to prepare for scale-up.
There may be reasons for changing formulation or process strategy during early product development (e.g. direct compression to granulation approach). As a result, being agile through having access to a broad range of processing equipment with scale-up capability is extremely advantageous.
The use of continuous processing strategies, such as roller compaction and continuous mixing, offer great potential for batch size flexibility. For larger batch sizes you simply run the process for longer. The FDA’s ‘scale-up and post approval changes’ (SUPAC) guidelines1,2 provide a useful framework for manufacturing scale-up and it is highly beneficial if equipment of the same SUPAC class is available for development, scale-up and commercial manufacturing.
Throughout a drug product development program it is important to build robustness and flexibility into the manufacturing process. In this article, Dr. Kashif Ghaffar, process validation pharmacist at Pfizer’s Freiburg facility, discusses what needs to be considered during product development in preparation for commercial manufacture.