Arch Pharmalabs Ltd. announced that it will represent Texcell SA, a world-renowned service company based in France providing viral safety and immunology services in full compliance with GLP and GMP standards in India. Arch Pharmalabs Ltd. will ensure that the Biopharmaceutical industries in India get their viral safety testing and viral validation studies done rapidly and efficiently.
Commenting on the collaboration, Ajit Kamath, chairman and MD, Arch Pharmalabs Ltd. said "Indian biotech industry is growing at 34.5 per cent and is expected to touch the $5 billion mark by 2010. All Biopharmaceuticals need to undergo safety assessment (viral safety and clearance assessment).This representation of Texcell SA in India will enable us to provide long term partnerships to customers for providing testing facilities closer to their manufacturing entities in India".
Texcell SA has been operating since 1987 and has in-depth experience of providing quality viral safety testing and virus validation studies. It has provided support to a large number of products now licensed by the FDA, the EMEA and the MHW: recombinant proteins, monoclonal antibodies, vaccines, gene therapy products, medical devices and other products of human or animal origin, such as blood derived products, heparin, hyaluronic acid and collagen. Texcell SA also has a central lab for pre-clinical and clinical trials. It offers a dedicated technology platform in immunology, together with comprehensive assay development under GLP conditions for monitoring humoral or cell-based immune responses.
Biopharmaceuticals comprises of recombinant therapeutics and vaccines which constitutes the largest segment of the bio-tech industry both in terms of domestic and export revenues. The safety assessment of biopharmaceuticals products that are derived from a human or animal source (such as human blood or plasma, monoclonal antibodies, and other recombinant products manufactured in mammalian cell cultures) is a major requirement as a part of the CMC sections of the regulatory submissions.
Viral safety and clearance studies of the manufacturing processes, represents the critical component of this documentation. Such studies need to be performed under GLP (Good Laboratory Practice) compliance in pre-inspected and approved virology laboratories.