Aragen, a Contract Research Development and Manufacturing Organisation (CRDMO) for small molecules and biologics, has announced that it has operationalised the first phase of its biologics manufacturing facility in Bangalore, India through its 100% subsidiary, Aragen Biologics.
The facility is being set up at an investment of USD $30m. It has also executed its first small-scale manufacturing project for a US-based organisation for manufacturing a novel anticancer monoclonal antibody (mAb).
The non-GMP facility can undertake batch sizes up to 50L 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, US.
Services include 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 advanced single-use bioreactors with capacities ranging from 50 to 2000L, and will offer integrated solutions including process development, process validation, analytical development, small-scale manufacturing, large-scale DS manufacturing and stability services.
