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Syngene International, a global contract research, development,
and manufacturing organisation (CRDMO), reports that its newly upgraded
biologics facility (Unit 3) in Bangalore, India, will be operational for
clinical and commercial supply for U.S. and European clients in the second half
of 2024.
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 one million vials per day ranging from one to 100ml fill volumes. In
addition to the production capacity, the site has a development suite for
clinical supply of drug substance equipped with a 500L single-use bioreactor.
The facility triples Syngene’s biomanufacturing capacity and
adds to its existing commercial manufacturing Bangalore site (BMP 1), which has
been approved by the FDA and EMA, as well as a PROTAC research site in
Hyderabad, India.
Syngene officials say the company has further expansion
plans for two additional vial filling isolator lines with capacity for six
hundred vials/minute and one hundred 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,” said Jonathan Hunt, MD, CEO,
Syngene International. “In particular, there is demand from commercial clients
looking for immediately available capacity.”
The $98 million manufacturing site is integrated with other
biologics capabilities in the city including around 170 R&D scientists. 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, according to Alex Del Priore,
senior vice president, manufacturing services, Syngene International.
“Unit 3 provides the capacity to support our customers’
growth and will become our flagship location for both our core business and the
emerging growth areas in ADCs or cell and gene therapy,” he continued.
“The site is integrated with nearby R&D, drug substance
and drug product capabilities to improve our time to clinical trials and reduce
cost per gram.”
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INDUSTRIAL PRODUCTS FINDER (IPF) is India’s only industrial product portal. Referred to as the ‘Bible’ of the manufacturing sector in India,
INDUSTRIAL PRODUCTS FINDER (IPF) is India’s only industrial product portal. Referred to as the ‘Bible’ of the manufacturing sector in India,
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