PATH Malaria Vaccine Initiative (MVI) and CMC Biologics have agreed to partner in the development of monoclonal antibodies to protect humans from malarial infection. CMC Biologics will manufacture the monoclonal antibodies developed by MVI in a CHEF1 cell line.
The antibody was designed to target circumsporozoite protein (CSP) produced by P. falciparum, the parasite that causes malaria. Once CMC begins production of antibodies they will be used by MVI in a clinical trial to study their potential as an antimalarial.
“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,” says Dr. Ashley Birkett, director of MVI.
Development of the expression system will be performed at one of CMC’s facilities in Bothell, Washington. GMP manufacturing of the antibodies will be conducted at the company’s facility in Berkeley, California.
Dr. Gustavo Mahler, CMC Biologics chief operations officer 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.”
He added: “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 CHEF1 cell line development platform designed by CMC promises to generate 500g of monoclonal antibodies in a cost-effective manner under cGMP guidelines. The monoclonal antibodies will be used in Phase I/II clinical trials performed by MVI.
“We will help MVI achieve its mission to accelerate the development of promising malaria vaccines, for much-needed use in the developing world,” declared Mahler.
- CMC and PATH MVI to develop monoclonal antibodies for malaria infection – http://www.pharmaceutical-technology.com/news/newscmc-path-mvi-develop-monoclonal-antibodies-malaria-infection-4647076