Biocon Biologics receives EU GMP certification for its new manufacturing unit for mAbs
Biocon Biologics, a subsidiary of Biocon has received EU GMP certificate from the Health Products Regulatory Authority (HPRA), Ireland, for its new monoclonal antibodies (mAbs) drug substance manufacturing facility (B3). The facility is located at the Biocon Park, Bengaluru, following a GMP inspection in April 2022.
The facility, spread across 3,40,000-square feet, will enhance our capabilities manifold to manufacture drug substance of our mAbs portfolio. It will enable us to serve patients across the globe. 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 (FOYA) with a mention by the International Society for Pharmaceutical Engineering
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