Following a successful facility and equipment qualification at its biologics manufacturing site in Bangalore, Aragen will commence GMP manufacturing in July.
The contract research, development and manufacturing organisation (CRDMO) has demonstrated the productivity of its intensified fed batch cell culture manufacturing platform to deliver titers >25 g/L.
This news comes just before BIO Boston, and after several successful pharma customer audits.
The facility could house multiple 2KL single use bioreactors, set up for both fed batch and intensified fed batch production.
According to the company, it can deliver one batch ever 4–5 days at full capacity.
The bioreactors are configured with multiple 2KL units feeding into a single downstream purification suite, providing flexibility to run multiple client projects in parallel or scale up a customer's production to commercial levels.
Aragen's Bangalore facility complements the company's current biologics development and manufacturing infrastructure in Morgan Hill, California, which will together offer:
- Cell line development
- Process and analytical development
- QC and GMP monoclonal antibody manufacturing
- Biosimilar/recombinant protein production
The California site currently provides non-GMP manufacturing for batches from 1L to 50L across six separate suites.
“Our first customer programme will progress to GMP production as early as late July this year," noted Subodh Deshmukh, CEO, Biologics and President, Development.
"The Bangalore manufacturing facility will help seamless transition to GMP manufacturing using not only intensified fed batch production, but also, our proprietary high-yield CHO-GS and CHO-DG44 cell lines,”
"With cutting-edge infrastructure and deep technical expertise under one roof, the Bangalore facility is designed to seamlessly support our partners from early discovery through to commercial manufacturing," added Jamie Cascio, AVP, Biologics.
"It strengthens our ability to offer speed, scalability, and compliance — enabling our customers to accelerate the journey of their biologics molecules to market with confidence," he concluded.
