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.
Join us 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.
- 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