Biocon Biologics' antibody drug unit in Bengaluru gets EU GMP certificate

Approval comes from Irish health regulator, which had flagged some deficiencies in the manufacturing process iin May

Biocon Biologics Ltd., a subsidiary of Biocon, has received a EU GMP certificate from the Health Products Regulatory Authority (HPRA), Ireland, for its new monoclonal antibodies (mAbs) drug substance manufacturing facility (B3) at Biocon Park, Bengaluru, following a GMP inspection in April 2022, the company said.

The facility, spread across 340,000-square feet, will enhance Biocon Biologics' capabilities manifold to manufacture drug substances in its mAbs portfolio.

"This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing. Upon successful completion and qualification in 2021, it was awarded the Facility of the Year Award with an Honorable Mention by the