- Syngene International announces its upgraded biologics facility, Unit 3, in Bangalore, India.
- The facility includes 20KL of single use drug substance capacity and drug product filling capacity of up to one million vials per day and is set to be operational for clinical and commercial supply in H2 2024.
Syngene International, a contract research, development and manufacturing organisation (CRDMO) has announced that its newly upgraded biologics facility ‘Unit 3’ would be operational for clinical and commercial supply in the second half of 2024.
The facility will be available for biotech and pharma customers seeking drug substance and drug product contract manufacturing. The drug substance capacity includes two production suites with five 2KL single use bioreactors each, for a total capacity of 20KL. The facility also includes two high-speed vial filling lines capable of producing up to 1 million vials per day ranging from 1 to 100mL fill volumes.
“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.” commented Jonathan Hunt, MD & CEO, Syngene International Ltd.
The $98m manufacturing site is integrated with other biologics capabilities in the city including around 170 R&D scientists located nearby offering clients a seamless transition from discovery biology services into clinical and commercial manufacturing. The Company also has a microbial cGMP facility and a mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients.
In total, Unit 3 will have around 100 staff for Quality Assurance and Manufacturing, part of Syngene’s 600-strong team across its biologics manufacturing services and supporting specialist functions. This expansion not only triples Syngene’s bio manufacturing capacity but also 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.
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