CMC Biologics, a global leader in clinical and commercial development and contract manufacture of therapeutic proteins, has entered into an agreement with the PATH Malaria Vaccine Initiative (MVI) for process development and manufacture of specific monoclonal antibodies to test for their capacity to protect humans from malaria infection.
Under this agreement, CMC Biologics 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. Process development will be conducted at CMC Biologics’ Bothell, Washington facility and transferred to its Berkeley, California facility for GMP manufacturing. Pending successful outcome, this study may lead to evaluation of additional monoclonal antibodies, targeting different epitopes, engineered to protect humans from infection.
“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,” said Gustavo Mahler, PhD, global chief operations officer, CMC Biologics.
“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.”
“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,” said Ashley J. Birkett, PhD, director, MVI.
“Assuming this initial study is successful, we will evaluate other antibodies targeting novel vaccine targets for their capacity to protect humans from infection and therefore inform future vaccine development efforts.”
CMC Biologics offers a stable, well characterized, monoclonal cell line based on the CHEF1 cell line development platform that is a cost-effective platform for delivering 500 grams monoclonal antibody manufactured under cGMP for phase I/II clinical studies, material that is scalable to large scale for late phase and commercial production in a remarkable 12 months.