Biocon Biologics' antibody drug unit in Bengaluru gets EU GMP certificate

Approval comes from Irish health regulator, which had flagged some deficiencies in the manufacturing process iin May

Biocon Biologics Ltd., a subsidiary of Biocon, has received a EU 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 company said.

The facility, spread across 340,000-square feet, will enhance Biocon Biologics' capabilities manifold to manufacture drug substances in its mAbs portfolio.

"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.

In May the company had said that Ireland's health regulator has reported some deficiencies in the manufacturing process at the company's plant.

"The inspection report contains no 'critical' observations and only one of the deficiencies is categorised as 'major' which is being addressed expeditiously in consultation with the regulatory agency," the spokesperson had said.

The facility will help the company address the additional requirements of products in the European Union market, the company had said.

Biocon Biologics has recently acquired Viatris’ biosimilars business in a $3.3 billion cash and stock deal. The transaction is expected to close in the second half of 2022, subject to satisfaction of closing conditions (including certain regulatory approvals). In February BBL executive chairperson Kiran Mazumdar-Shaw had said it is looking to launch an initial public offering in the next 18-24 months.