Glenmark Pharmaceuticals inaugurates new Antibody Manufacturing Facility in La Chaux-de-Fonds, Switzerland
Glenmark opens a new cGMP-compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland
• State of the art manufacturing facility for supply of clinical trial material
• With the facility Glenmark has end-to-end capabilities for the development of novel, state-of-the-art monoclonal antibodies including bi-specific antibodies
La Chaux-de-Fonds, Switzerland, June 4, 2014 – Glenmark Pharmaceuticals S.A (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited, India (GPL), announced the opening of its new cGMP compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland. This manufacturing facility supplements Glenmark’s existing in-house discovery and development capabilities and will supply material for clinical development.
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.
4th-Jun-2014 10:33Source: BSE
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
La Chaux-de-Fonds, Switzerland ………city