The upcoming Indian facility will be used to develop and manufacture therapies including monoclonal antibodies, therapeutic proteins, fusion proteins and cell and gene therapies. As part of the development, the services will include process validation, analytical development, pilot production, and more.
Within the facility, there will be process development and quality control labs in addition to Good Manufacturing Practices (GMP) manufacturing suites equipped with single-use bioreactors and downstream purification equipment. The process development laboratory is scheduled to be operational by late 2024 and the first of the manufacturing suites is planned to open in late 2025.
“Aragen has been a leader in biologics discovery and development services for nearly three decades from our California site, spanning cell line and antibody development. Our platform technology has so far enabled our partners to rapidly advance biotherapeutics to the clinic and several successful commercial products use Aragen-derived CHO cell lines,” said Subodh Deshmukh, CEO of Aragen’s subsidiary Aragen Biosciences, in a public release.
“With the opening of our biomanufacturing facility, we will empower our customers with even faster development timelines and support their full lifecycle journey from clone development to cell culture manufacturing making Aragen a ‘one-stop’ solution provider for large molecules.”
According to Manni Kantipudi, CEO of Aragen Life Sciences, early-stage discovery would take place in the CDMO’s U.S. facilities and then transfer the program to its Bangalore premises to manufacture the product at scale.
The CRDMO works with customers from a range of sectors including pharma, biotech, agrochemical, and animal health industries. According to the company, it has helped 400 customers, including 6 of the top 10 pharmaceutical companies globally, to progress their therapies from preclinical to clinical development and beyond.
The latest investment comes just weeks after Aragen commissioned a $3 million formulations manufacturing facility in Hyderabad. It also happens as many CDMOs invest in more manufacturing facilities worldwide, including a $1.5 billion plant to be opened by Samsung Biologics in 2025.