Aragen, a Contract Research Development and Manufacturing Organization (CRDMO) for small molecules and biologics, is setting up a new biologics manufacturing facility in Bangalore, India.
The state-of-the-art facility is part of a $30m investment, spanning nearly 160,000 sqm, and includes process development labs and multiple GMP manufacturing suites with supporting functions like quality control labs (analytical and microbiology).
The manufacturing suites will be equipped for intensified processing using single-use bioreactors and advanced downstream purification capability to serve it’s rapidly expanding biologics customer base.
The facility will offer integrated solutions from process development, process validation, analytical development, pilot production, large-scale DS manufacturing and stability services. It will have the capability to develop and manufacture mAbs, therapeutic proteins and fusion proteins to augment the company’s bioproduction capability in California.
Subodh Deshmukh, CEO, Aragen Bioscience Inc, said: “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.
“With the opening of our bio-manufacturing 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.”
Manni Kantipudi, CEO, Aragen Life Sciences, added: “Setting up of a biologics manufacturing facility in India is part of our forward integration strategy for our US-based biologics business, allowing Aragen to offer integrated Gene-to-GMP solutions to our customers.
“Once this facility is commissioned, Aragen will offer a unique value proposition to our biologics customers where the early-stage discovery will be executed in our R&D labs in California, where we have access to the top scientific talent and have proximity to our customers. As the molecule advances, Aragen can tech-transfer the program to our world-class manufacturing facility in Bangalore, offering better COGS to our customers.”
The process development laboratory is scheduled to be operational by the third quarter of FY 24 while the first manufacturing suite will open in the third quarter of FY 25. The facility is designed to include plasmid DNA, mRNA, cell and gene therapy, microbial manufacturing and additional GMP manufacturing suites in the future as demand ramps up.
