The state-of-the-art facility, Aragen said, is part of a $30 million investment, spanning nearly 160,000 m², and includes process development labs and multiple GMP manufacturing suites with supporting functions like quality control labs. The manufacturing suites will be equipped for intensified processing using single-use bioreactors and advanced downstream purification capability.

The facility will offer integrated solutions from process development, process validation, analytical development, pilot production, large-scale drug substance manufacturing and stability services. It will have the capability to develop and manufacture monoclonal antibodies (mAbs), therapeutic proteins and fusion proteins to augment the company’s bioproduction capability in California, USA.

“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,” commented Subodh Deshmukh, CEO of Aragen Bioscience.

Manni Kantipudi, CEO of subsidiary 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.”

According to Aragen, the process development laboratory is scheduled to be operational by the third quarter of fiscal year 2024 while the first manufacturing suite will open in the third quarter of fiscal year 2025. 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.