Phase III

JMPS is well equipped to help you prepare your API manufacturing process for commercial launch. Our goal is to give you the best process & analytical development support while enabling your Phase III clinical program and assisting you to prepare for your NDA submission.

Our process scientists will help to refine your manufacturing process with a view on what is needed for long-term production. We’ve found this approach reduces the need for expensive secondary filings and amendments. Once the best manufacturing process is defined, either a risk-based or failure-point approach to critical parameter evaluation will be conducted to prepare for process validation, depending on your approach to quality control. Throughout Johnson Matthey’s Fine Chemicals Division, we have a wealth of experience validating processes for commercialization of APIs.

Both of our research and manufacturing facilities are equipped to handle potent molecules. We have the technology to perform catalytic process screening to optimize catalyst type and loading, as well as process parameters around the catalytic chemistry. Utilizing our separations technologies, we will isolate and identify low-level impurities for use as qualified reference standards, solidifying the quality of your NDA.

During Phase III development and production, all API methods are validated and final product specifications are tightened. Analytical methods for key starting materials, intermediates, and critical in-process controls are validated at this stage, as well as cleaning method validation studies.

A gap analysis is performed to ensure process controls are appropriate in anticipation of the NDA filing. Throughout this process, the entire JMPS project team, including Process Development, Production, Analytical, QC, QA, and Regulatory Affairs, works closely with you to ensure that your project is ready for process validation and NDA filing.