Canton Biologics provides formulation development services for all sorts of protein drugs (e.g. monoclonal antibodies, bispecific antibodies, fusion proteins, recombinant proteins, and ADC etc.). The team leader has >10 years of experience in biologics formulation development and has successfully completed 9 biologics formulation development projects(including antibodies and recombinant proteins, of which 2 projects have reached the BLA approval) during the past 3 years, including 1 project has successfully obtained the FDA IND approval.
- Antibody/recombinant protein formulation development
- Strategies to solve stability issues related to the molecule
- High-throughput stability screening platform
- 384 samples can be assessed within 1 hour
- Formulation excipients and packaging materials quality standard platform
- Excipients and packaging materials meet the targeted country pharmacopoeia standards as wellas the regulatory requirements
- DP process development platform
- Ensure DP stability throughout the entire manufacturing process