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news.CMC Biologics has entered into an agreement with the PATH Malaria Vaccine Initiative (MVI) for process development and manufacture of specific monoclonal antibodies to test their capacity to protect humans from malaria infection.
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As part of the deal, CMC will develop a CHEF1 production cell line and process for manufacture of MVI’s monoclonal antibody, targeting circumsporozoite protein (CSP), for use by MVI in clinical research to study protection from P. falciparum infection.
CMC will carry out process development at its Bothell, Washington facility and transferred to its Berkeley, California facility for GMP manufacturing.
CMC Biologics global chief operations officer Gustavo Mahler said: "By utilizing 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."
The company noted that pending successful outcome, the study may lead to evaluation of additional monoclonal antibodies, targeting different epitopes, engineered to protect humans from infection.