Biocon Biologics Ltd, a subsidiary of Biocon Ltd, has received a European Union (EU) goods manufacturing practice (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 340,000 square feet facility, will enhance our capability to manufacture drug substances of our mAbs portfolio and will enable us to serve patients across the globe. This facility integrates manufacturing suites, analytical testing laboratories, and warehousing,” said a spokesperson from Biocon Biologics.
In 2021, it was awarded the Facility of the Year Award (FOYA) with an Honorable Mention, by the International Society for Pharmaceutical Engineering (ISPE).
The good manufacturing practice certificate (GMP) describes the minimum standards that pharmaceutical manufacturers must meet in their production processes.