Practical Considerations For Your Sub-Contracted Process Characterization (PC) Study

By Dr. Ian Brown, Senior Director PC & PV Sciences, FUJIFILM Diosynth Biotechnologies, Billingham, UK

Subcontracting a Process Characterization (PC) study can be an expedient and practical undertaking for a biopharmaceutical company. Utilizing the services of an experienced PC team with proven workflows that have been used successfully to support licensure of products will strengthen the robustness of the Chemistry Manufacturing and Controls (CMC) section of any license application and should return its investment, with a smooth transit through the regulatory approval process, avoiding costly delays to the commencement of Commercial manufacturing due to re-work at the ‘reviewer questions’ stage.

To maximize the benefit of outsourcing a PC program, special attention should be paid to specific considerations that will help to ensure that the program runs well at your chosen contractor without a requirement for rework or changes of scope throughout the program. This article discusses in-depth the three principal areas to consider:

• Feed materials
• Small Scale Model (SSM) and experimental range requirements
• Sample analysis and data interpretation