Macrogenics has developed its cell line for the biologic product, and is transferring it to CMC for optimization, to be followed by process development and clinical manufacturing of the drug, CMC told BioPharma-Reporter.com.
The company will manufacture the mAb (monoclonal antibody) using a stainless steel bioreactor suite rather than single-use systems, said Stacie Byars, Global Marketing, CMC.
CMC had been chosen for the task, she said, because Macrogenics was looking for an “innovative partner” CMO which would act as “an extension of their own technical team.”
OncoSynergy deal
The latest deal is one of several CMC has signed this year for mAb and complex protein development and manufacturing. Most recently it announced an agreement with OncoSynergy for development of its “OS2966” mAb programme, a strategy that aims to inhibit several cancer growth mechanisms with a single drug.
For OncoSynergy, CMC will perform cell-line development, process development, analytical development and manufacturing of non-GMP material, to enable early toxicology testing and cGMP material for IND (investigational new drug) authorization toxicology studies and Phase I clinical trials.
ICH compliance vital for clients
CMC’s Byars told BioPharma-Reporter.com biologics makers turn to outsourcing because of a lack of facilities. “Most biopharmaceutical companies, large and small, do not have the resources – both equipment and technical expertise on staff – to conduct PD [pharmacodynamics] and manufacturing.
“However, they are very choosy (and should be) about the CMO they choose – ensuring that the CMO of choice has exceptional quality systems and is in compliance with ICH [International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use] regulatory requirements for development and production.”
CMC has facilities in Copenhagen, Denmark and Seattle, Washington.