Manufacture of monoclonal antibodies to the malaria parasite scheduled for CMC Biologics’ Berkeley facility
Seattle, Wash. and Berkeley, Calif. – August 12, 2015 – CMC Biologics, a global leader in clinical and commercial development and contract manufacture of therapeutic proteins, announced today it 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 MVIin 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 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, 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.”
About 2.012 Accelerated Antibody Development Solution 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.
About CMC Biologics
CMC Biologics is leading the industry among CMOs in customer satisfaction, technical excellence, and quality – Right and On Time. With three facilities in the USA and Europe, the Company provides fully integrated biopharmaceutical development and manufacturing solutions to clients globally. The Company has proven expertise in delivering custom solutions for the scale-up and cGMP manufacture of protein-based therapeutics for pre-clinical, clinical trials and commercial production. The Company’s wide range of integrated services includes cell line development, bioprocess development, formulation and comprehensive analytical testing. Clients can also benefit from CMC Biologics’ proprietary CHEF1® expression system for mammalian production. CMC Biologics has fully segregated microbial fermentation and mammalian cell culture suites and offers both fed-batch and perfusion production processes. More detailed information can be found at www.cmcbiologics.com.
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