Mumbai-based Glenmark Pharmaceutical Limited, which focuses on research to develop new chemical entities (NCEs) and new biological entities (NBEs), is launching a new cGMP-compliant monoclonal antibody manufacturing facility in Switzerland.
“We are working in the area of novel monoclonal antibodies and have several monoclonal antibody candidates and bispecific antibodies in the pipeline. This manufacturing facility would help us bring these antibodies to the clinic faster and position Glenmark as a leading innovative pharmaceutical company,” said Michael Buschle, president – Biologics, Glenmark Pharma.
The manufacturing facility has been designed for use of single use bioreactor system and also houses a suite for manufacturing cell bank. It is fully compliant with quality, environmental and safety standards for manufacturing clinical trial material, according to the release.
Glenmark’s Swiss research centre focuses on developing novel biologic entities for the treatment of pain, inflammatory, oncologic and respiratory conditions. The company currently has 69 employees working for this research centre.
This research centre is an integrated antibody discovery and development unit. It has earlier fully developed in-house capabilities and infrastructure for conducting antibody discovery, cell line development, in vitro testing and characterisation of antibodies, process development and analytical research, according to the stock exchange announcement.
According to the release, since its inception Glenmark’s Biologics research centre in Switzerland has filed several patents on novel biologic entities.
“GBR500 has been licensed to Sanofi and is currently in Phase 2 development. GBR 900 is in phase 1 and GBR830 is scheduled to enter the clinic later this year,” company said in the release.
Glenmark reported an increase in revenue by 20 per cent at Rs 6,007 crore for FY14. The net profit of the company stood at Rs 542 crore.
(Edited by Joby Puthuparampil Johnson)