Biocon Biologics Limited, a subsidiary of Biocon Limited, has received the European Union's good manufacturing practice (GMP) certificate from the Health Products Regulatory Authority (HPRA) Ireland for its new monoclonal antibodies (mAbs) drug substance manufacturing facility in Bengaluru.
The certification came after a GMP inspection of the plant in April 2022.
According to the company, the facility that spreads across 340,000 square feet will enhance the company's capability to manufacture the drug substance of mAbs portfolio and will enable it 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 with an Honorable Mention by the International Society for Pharmaceutical Engineering,” said a company spokesperson.