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EU GMP certification received by Biocon Biologics for a new facility in Bengaluru

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Peeyush Ghalot
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(Image Courtesy: - Biocon)

The new monoclonal antibodies (mAbs) drug substance manufacturing facility at Biocon Park, Bengaluru, has received certification from the Health Products Regulatory Authority (HPRA), Ireland, that it complies with EU Good Manufacturing Practices. Biocon Biologics is a Bengaluru-based biotechnology subsidiary of Biocon Ltd. (GMP). Pharmaceutical businesses that adhere to a tight set of manufacturing requirements are eligible for Good Manufacturing Practices (GMP) accreditation from the European Union. According to the company's regulatory application, the 340,000 square foot facility would significantly increase its ability to produce the therapeutic components for its portfolio of mAbs, enabling it to serve patients all over the world. The structure is also configured to incorporate production suites, labs for analytical testing, and warehouses, according to information given by the firm. The facility was also given the Facility of the Year Award (FOYA) with an Honourable Mention by the International Society for Pharmaceutical Engineering (ISPE) upon completion and qualification in 2021, according to a statement issued by a spokesman for Biocon Biologics.

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