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news.Glenmark Pharmaceuticals (GPSA), a wholly-owned subsidiary of Glenmark Pharmaceuticals Limited (GPL), has opened its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland.
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This manufacturing facility supplements Glenmark’s existing in-house discovery and development capabilities and will supply material for clinical development.
Glenmark Pharmaceuticals’ Swiss research center is an integrated antibody discovery and development unit. The research center has fully developed in-house capabilities and infrastructure for conducting antibody discovery, cell line development, in vitro testing and characterization of antibodies, process development and analytical research.
The new manufacturing facility supplements the research and development capabilities and will facilitate production of clinical grade material.
The manufacturing facility has been designed for use of single use bioreactor systems and also houses a suite for manufacturing cell banks. The facility is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material.
Dr. Michael Buschle, President – Biologics, Glenmark Pharmaceuticals Ltd. commented, "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. The manufacturing facility would help us bring these antibodies to the clinic faster and position Glenmark as a leading innovative pharmaceutical company."
Glenmark’s biologics research center in Switzerland has a robust pipeline of monoclonal antibodies in various stages of development including bispecific antibodies.
The focus for the biologics R&D center is to develop novel biologic entities for the treatment of pain, inflammatory, oncologic and respiratory conditions. Glenmark currently has 69 employees at its biologic research center.
In its short existence of just about 10 years, Glenmark’s biologics research center has filed several patents on novel biologic entities. GBR 500, its most advanced candidate, has been licensed to Sanofi and is currently in Phase 2 development.
GBR 900, a first-in-class molecule for treatment of chronic pain, is currently in Phase 1 and GBR 830, an anti OX-40 antagonist, is scheduled to enter the clinic later this year. The scientists at Glenmark have also invented a best-in-class technology platform to manufacture bispecific antibodies, BEAT.