Practical Considerations for your Sub-contracted Process Characterization (PC) Study
Dr. Ian Brown, Senior Director PC & PV Sciences, FUJIFILM Biotechnologies, Billingham, UK
Process characterization… an outsourced activity?
This white paper offers concise, practical guidance for biopharma teams outsourcing Process Characterization (PC) to strengthen CMC packages and accelerate commercialization. Subcontracting Process Characterization (PC) can strengthen CMC submissions and streamline regulatory review when supported by deliberate planning in three areas: feed materials (representative, sufficient, stable, with options for intermediate-scale and worst‑case feeds), small‑scale models (risk‑based justification, ranges aligned to manufacturing capability, and compatibility with high‑throughput contractor equipment), and analytics (early CQA assignment, fit‑for‑purpose assay qualification, comprehensive sampling, and pre‑agreed statistical/reporting methods). With robust tech transfer and modular, parallel work packages, timelines can be compressed. Partnering with experienced providers such as FUJIFILM Biotechnologies provides the expertise, tools, and workflows to minimize rework and enable a smooth transition through PPQ to licensure.