Aragen Life Sciences, a CDMO of small molecules and biologics, is proceeding with a biomanufacturing expansion. Dr. Subodh Deshmukh, CEO, Biologics & President, Development Services, Aragen Life Sciences, provided an update at the DCAT Member Company Announcement Forum held on March 18th, 2024, at DCAT Week. 

Aragen Life Sciences is investing $30 million for a cell-culture biomanufacturing facility in  Bengaluru (Banagalore), India. The process development laboratory has been operational since December 2023. The first manufacturing suite is scheduled to be operation by December 2024.

Key features of the facility include:

o          Purpose-built facility streamlined for end-to-end operations

o          Process development, analytical development, production suites, GMP quality control, and GMP warehouse under one roof

o          50-L to 5-KL single-use platform, up to 21 KL bioreactor capacity

o          Multi-product handling and unidirectional material/people movement

o          Facility design complies to global regulatory requirements – ICH Q7, EMA, PIC/S & US FDA guidelines for biopharmaceutical manufacturing

o          Proficient team for phase-appropriate development & GMP manufacturing with a commitment to safety and quality compliance standards by current regulations

o          Successful quality and regulatory track record (US, European Union, Australia, Japan, and the UK regulatory agencies).

Aragen currently offers discovery and development research services from its R&D labs in California. 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. The new facility will have advanced single-use bioreactors with capacities ranging from 50 L to 2,000 L and will offer integrated solutions, including process development, process validation, analytical development, small-scale manufacturing, large-scale drug-substance manufacturing, and stability services. It will have the capability to develop and manufacture monoclonal antibodies, therapeutic proteins, and fusion proteins to augment the company’s bioproduction capability in California.