Syngene International is set to announce that its newly upgraded biologics facility – Unit 3 – would be operational for clinical and commercial supply in the second half of 2024, at DCAT 2024.

The facility triples Syngene’s bio manufacturing capacity and adds to its existing commercial manufacturing site in Bangalore, India – BMP 1 – which has been approved by the US FDA (with no 483 observations) and EMA, as well as a PROTAC research site in Hyderabad, India.

The new facility includes 20KL of single-use drug substance capacity coupled with drug product filling capacity of up to one million vials per day. Syngene has further expansion plans for two additional vial filling isolator lines with capacity for 600 vials/minute and 100 vials/minute respectively and drug substance expansion into perfusion cell culture processing.

“We see interest not only from existing partners looking to move innovative biologics into clinical and commercial manufacturing, but also from new biotechs and big pharma companies. In particular, there is demand from commercial clients looking for immediately available capacity. With US FDA and EMA approvals in place, Unit 3 is a very attractive option, so we are preparing for a busy week at DCAT,” commented Jonathan Hunt, MD & CEO, Syngene International Ltd.

The $98 million manufacturing site is integrated with other biologics capabilities in the city including around 170 R&D scientists located nearby.

Alex Del Priore, Senior Vice President – Manufacturing Services, Syngene International added that Unit 3 will become their flagship location for both the core business and emerging growth areas in ADCs or cell and gene therapy, pointing out that integration with nearby R&D, drug substance and drug product capabilities will improve time to clinical trials and reduce cost per gram.