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Aragen Operationalizes Biologics Manufacturing Facility in India

Executes the first project for developing and manufacturing a novel anticancer mAb.

By: Kristin Brooks

Managing Editor, Contract Pharma

Aragen, a Contract Research Development and Manufacturing Organization (CRDMO) for small molecules and biologics, has operationalized the first phase of its biologics manufacturing facility in Bangalore, India through its subsidiary, Aragen Biologics Pvt Ltd. The facility is being set up with an investment of $30 million and has executed its first small-scale manufacturing project for a U.S.-based organization for an anticancer monoclonal antibody (mAb). The non-GMP facility can undertake batch sizes up to 50 Liters and includes process development and analytical labs to support the manufacturing activities. 
 
Manni Kantipudi, CEO Aragen Life Sciences and Director of Aragen Biologics Pvt Ltd. said, “We are happy to announce the commissioning of the first phase of our biologics manufacturing facility at Bangalore, India as per schedule and the successful completion of the first project at this facility. This brings us one step closer to offering full-scale Gene-to GMP solutions to our customers. Once the facility’s expansion is fully operational by the end of this calendar year, we will be able to do internal tech transfer from our R&D labs in California to the manufacturing site in India, thereby enabling end-to-end integrated service offering to customers.”
 
Aragen currently offers discovery and development research services from its R&D labs in California, including cell line development, upstream and downstream development, protein science, and antibody discovery. The biologics manufacturing facility at Bangalore will complement these services and will enable GMP and non-GMP manufacturing. It will have single-use bioreactors with capacities ranging from 50 to 2000 Liters and will offer process development, process validation, analytical development, small-scale manufacturing, 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.

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