Containment In A High Potent Manufacturing Facility

By David O’Connell, Director of Scientific Affairs PCI Pharma Services

As the market continues to evolve with increasing numbers of highly potent molecules in development, it is important to understand the requirements for the safe processing of such molecules, the differing regulatory requirements across the world, and the safety of employees and the environment.

When manufacturing drug products containing HPAPIs, processes carried out under negative pressure process rooms isn’t enough. High-grade specialized containment equipment is also required in order to protect employees from the API itself, and to ensure drug product integrity in a multi-product facility. A strategy based on Quality by Design (QbD) is necessary to ensure process reliability and reproducible product quality, with scientifically designed products and processes, and the control of Critical Process Parameters (CPP) with respect to the Critical Quality Attributes (CQA) and Quality Target Product Profile (QTPP).

Partnering with a CDMO can help drug sponsors efficiently utilize the right technical capabilities, knowledge and experience to successfully manage the project. Examine how to assess a CDMO’s capabilities and experience in the handling of potent drug substances, their regulatory expertise and compliance history, and their capacity to provide long-term support for clinical and commercial supply.