BioFrey has led CMC activities for early and late phase biologics as well as cell and gene therapies. BioFrey has experience in process development CDMO selection and tech transfer. Key highlights include:

- Successful transfer to Chinese CDMO for Phase III+ Covid therapeutic
- Identification of process changes leading to elevated HCP in BDS (Corrected batch was cleanest at CDMO and in line with other sites)
- Disaster recovery with support from supply chain (Column repacked in 3 weeks following CDMO error)
- Rapid identification of root cause driving differences in batch duration for 1st WCB batch (at phase III).
- Technical audit of CDMO sites
- Driving a company to CDMO selection in 6 months following 18 months of indecision for a marketed product

- Upstream and Downstream Processing
- Process Development
- Technology Transfer
- Creation of RFPs and selection of CDMOs/CROs
- Process extractables and Leachables
- Project management
- Authoring/reviewing module 3 sections
- Commercial planning (Demand, scale, COGs)
- Early Phase
- Late Phase