Glenmark Pharmaceuticals SA (GPSA), a subsidiary of Glenmark Pharmaceuticals Limited, India (GPL), has opened a new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland.
The company says the facility supplements existing in-house discovery and development capabilities and will supply material for clinical development.
Glenmark Pharmaceuticals' Swiss research centre is an integrated antibody discovery and development unit with in-house capabilities and infrastructure for conducting antibody discovery, cell line development, in vitro testing and characterisation of antibodies, process development and analytical research. The new manufacturing facility supplements the research and development capabilities and will enable production of clinical grade material.
Single-use bioreactor systems and a suite for manufacturing cell banks are included in the new facility, which is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material.
Michael Buschle, President – Biologics, at Glenmark Pharmaceuticals, said: 'This state-of-the-art manufacturing facility is a testimony to 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 will help us bring these antibodies to the clinic faster.'
There are currently 69 staff at the research centre developing biologics for the treatment of pain, inflammatory, oncologic and respiratory conditions.
In 10 years, the centre has filed several patents on novel biologic entities: GBR 500, its most advanced candidate, has been licensed to Sanofi and is currently in Phase II development; GBR 900, a molecule for the treatment of chronic pain, is currently in Phase I; and GBR 830, an anti OX-40 antagonist, is scheduled to enter the clinic later this year.
