Pilot Scale Production
Pharmaron has established a dedicated non-GMP pilot-scale production facility with floor areas of more than 10,000 ft2. The facility has been equipped with two 200L single-use fed-batch production lines, one downstream purification line and non-GMP product filling capabilities.
- IND-enabling toxicology study material production
- Process scale-up studies
- Technology transfer support
- Non-GMP batch production to meet NMPA filing requirements for process consistency and scalability
- Process characterization studies