Under the 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.
"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 Birkett, Director, MVI.
Process development will be conducted at CMC’s Bothell, Washington facility and transferred to its Berkeley, California facility for GMP manufacturing. Depending on the initiative’s success, the study may lead to the evaluation of additional mAbs targeting different epitopes.
"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," said Gustavo Mahler, 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."