Glenmark Opens New Antibody Manufacturing Facility In Switzerland
Glenmark Pharmaceuticals S.A. announced the launch of its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland. The new facility will supply clinical grade trial material and support the company’s existing in-house discovery and development capabilities.
The company’s Swiss research center currently operates as an integrated antibody discovery and development unit. The site is equipped with capabilities and infrastructure for conducting antibody candidate identification, in vitro testing and characterization of antibodies, process development, and analytical research. The site employs nearly 70 people for its biologics research.
The manufacturing facility, which houses a suite of cell banks, is built to utilize single use bioreactors. It is fully compliant with quality, environmental and safety standards for the manufacture of clinical trial material. Glenmark focuses operations of the biologics research center on developing monoclonal antibodies as well as bispecific antibodies. The new biologic entities are targeted against inflammatory, pain, oncologic and respiratory conditions. Indeed, Glenmark recently announced that its monoclonal antibody, GBR 900, was entering clinical trials to be investigated as a treatment for chronic pain.
Dr. Michael Buschle, President of Biologics at Glenmark Pharmaceuticals, said, “This state-of-the-art manufacturing facility is a testimony for Glenmark's commitment to growing its R&D and manufacturing facility in the canton of Neuchâtel. We have been doing cutting-edge work in the area of novel monoclonal antibodies and have several monoclonal antibody candidates and bispecific antibodies in the pipeline.” Buschle said that the new plant will help advance the company’s portfolio of antibodies into clinical development faster.
One of the research center’s several patents on novel biologics entities includes GBR 500. The drug is presently licensed to Sanofi and undergoing Phase II development. First-in-class molecule GBR 900 is in Phase I for treatment of chronic pain while GBR 830, an anti OX-40 antagonist, is set to begin clinical trial and development later this year. Company scientists have also built the technology platform, BEAT, to produce bispecific antibodies.
The Swiss site joins the list of Glenmark’s 13 manufacturing facilities and 6 R&D centers in four countries.