Glenmark Pharmaceuticals, on Wednesday, said its wholly-owned subsidiary, Glenmark Pharmaceuticals S.A., opened its new cGMP (current good manufacturing practice)-compliant monoclonal antibody manufacturing facility in La Chaux-de-Fonds, Switzerland.
An antibody or immunoglobulin is a protein produced by human plasma cells, and is used by the immune system to identify and neutralise foreign bodies such as virus and bacteria. The facility has been designed for use of single use bioreactor systems. It also houses a suite for manufacturing cell banks. It supplements Glenmark’s existing in-house discovery and development capabilities, and will supply material for clinical development, the company said in a statement.
Glenmark’s Swiss research centre is an integrated antibody discovery and development unit with infrastructure for conducting antibody discovery, cell line development, in vitro testing and characterization of antibodies, process development and analytical research.
Since being set up a decade ago, the centre is focused on developing novel biologic entities for treatment of pain, inflammatory, oncologic and respiratory conditions. It has filed several patents on novel biologic entities. GBR 550, its most advanced candidate, has been licensed to Sanofi and is now in Phase 2 development. GBR 900, a molecule for the treatment of chronic pain is in Phase 1 and GBR 830 an anti OX-40 antagonist, is to enter the clinic later this year.
Glenmark at present has 69 employees at the research centre and they have invented a technology platform to make bispecific antibodies — BEAT.
“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,’’ Michael Buschle, President, Biologics, Glenmark Pharmaceuticals, said in a statement, adding, “The manufacturing facility would help us bring these antibodies to the clinic faster and position Glenmark as a leading innovative pharmaceutical company.’’
