Title
Building a robust FIH biologics regulatory CMC package
Synopsis
When you enter the clinical trial stage of your molecule’s development, you must prepare a dossier to support conducting the clinical research. A critical component of this dossier is the package of documentation that supports the chemistry, manufacturing, and controls (CMC) of your molecule. A robust CMC package provides health authorities with the information to assess the quality of material entering clinical trials. Inadequate CMC supportive evidence or insufficient detail can delay the go-ahead to enter the clinic. At the same time, unnecessary granularity can impact the lifecycle management of the dossier.
Watch this on-demand webinar to learn how to develop a robust first-in-human (FIH) regulatory CMC package for recombinant biological molecules by integrating the following activities into your project plan.
The webinar will start after the introduction of Patheon pharma services’ integrated CDMO services offerings.
Learning points
- Progressively developing knowledge of the molecule’s critical quality attributes to justify the manufacturing and control strategy
- Planning for continuing development
- Identifying opportunities to enhance with scientific advice