"Biopharmaceuticals, an emerging opportunity for Indian drug companies, need to undergo safety assessment for regulatory clearance. Our tie-up with Texcell SA will enable us to provide testing facilities closer to their manufacturing entities in India," said Ajit Kamath, chairman and managing director, Arch Pharmalabs.
The 21-year old Texcell SA has in-depth experience of providing quality viral safety testing and virus validation studies and has provided support to a large number of products now licensed by regulatory authorities, they said.
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, is a major requirement as a part 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, explained sources.
The Indian biotech industry is growing at 34.5 per cent and is expected to touch the $5 billion mark by 2010. Biopharmaceuticals comprises of recombinant therapeutics and vaccines constitute the largest segment of the biotech industry.
