Biocon Biologics gets EU GMP certification
The Health Products Regulatory Authority (HPRA), Ireland, has certified Biocon Biologics, a Biocon Ltd. biotechnology subsidiary based in Bengaluru, that its new monoclonal antibodies (mAbs) drug substance manufacturing facility at Biocon Park, Bengaluru, complies with EU Good Manufacturing Practices (GMP).
Pharmaceutical companies are eligible for Good Manufacturing Practices (GMP) accreditation from the European Union if they follow a strict set of production guidelines.
The 340,000 square foot facility, according to the company’s regulatory filing, will greatly enhance its capacity to create the therapeutic ingredients for its portfolio of mAbs, enabling it to serve patients all over the world. According to information provided by the corporation, the building is also set up to house manufacturing suites, labs for analytical testing, and warehousing.
According to a statement made by a representative for Biocon Biologics, the facility was also given the Facility of the Year Award (FOYA) with an Honorable Mention by the International Society for Pharmaceutical Engineering (ISPE) upon its completion and qualification in 2021.