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Formulation Process Development

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
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