CMC Biologics has signed an agreement with PATH Malaria Vaccine Initiative (MVI) for process development and manufacture of specific monoclonal antibodies to test for their capacity to protect humans from malaria.
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Under the deal, CMC will develop a CHEF1 production cell line and process to manufacture MVI’s monoclonal antibody, targeting circumsporozoite protein (CSP), for use by MVIin clinical research to study protection from P. falciparum infection.
MVI director Dr Ashley Birkett said: "We chose CMC Biologics as our CMO partner for their sophisticated technical capabilities, successful track record in the industry, and speed of antibody development and production."
Process development will be carried out at CMC’s facility located in Bothell of Washington and then it will be shifted to the firm’s facility in Berkeley of California for GMP manufacturing.
Based on successful outcome, the study is expected to help in the assessment of additional monoclonal antibodies, targeting different epitopes engineered to protect humans from infection.
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By GlobalDataCMC Biologics chief operations officer Dr Gustavo Mahler said: "By utilising CMC Biologics’ 2.012 accelerated monoclonal antibody development solution, we will help MVI achieve its mission to accelerate the development of promising malaria vaccines, for much-needed use in the developing world.
"We will deliver cGMP material for MVI’s preclinical and Phase I/II clinical studies in a remarkable 12 months, the fastest development timeline in the industry from DNA to delivery."
CMC provides monoclonal cell line based on the CHEF1 cell line development platform, which is claimed to be a cost-effective platform to deliver 500g monoclonal antibody manufactured under cGMP for Phase I/II clinical studies.
Image: This photomicrograph of a blood smear contains a macro and microgametocyte of the Plasmodium falciparum parasite. Photo: courtesy of CDC/Dr. Mae Melvin.
