Indian CDMOs expand capacities: Syngene and Aragen lead the way

Making good on its promise, contract development and manufacturing organization (CDMO) Syngene has confirmed its Bengaluru biologics facility will be operational in the second half of 2024 to support US and European customers.

As reported by this publication in July 2023, the manufacturing facility includes 20 kL of single use drug substance capacity. According to the firm, the facility will also include two high-speed vial filling lines capable of filling up to one million vials per day. The site will deliver two oRABS (open Restricted Access Barrier System) lines running at 520 vials per minute.

Moreover, it is dedicated to the CDMO’s new biotech and pharma customers – with existing commercial manufacturing underway in Mangalore and Hyderabad.

“Indian CDMOs have moved up the value chain and I think most analysts agree we are likely to be among the big winners in the outsourcing space over the next few years,” Sridevi Khambhampaty, vice president, biopharmaceutical development at Syngene International told BioProcess Insider.

“So, while macroeconomic and supply side dynamics are part of the story - it’s really just a reflection of the quality of chemistry, biology and production.”

The INR 702 Crores ($86 million) cGMP and mammalian cell manufacturing facility will provide chemistry, manufacturing and control (CMC) development solutions for its global clients and will have around 100 staff for quality assurance and manufacturing.

“We have seen a change in perception in the last few years, accelerated by our Zoetis deal, and there is now a great deal of trust in not only undertaking development projects at Syngene, but also, in our potential as a commercial manufacturing partner. So, we are very much leading India forward as a global player in commercial biologics production,” said Khambhampaty.

The Unit 3 facility was previously owned by Stelis Biopharma and focused on the to produce Covid vaccine Sputnik Light. However, following decreased demand due to both the wain of the pandemic and the Russia-Ukraine conflict, parent company Strides agreed to offload the plant to the Biocon subsidiary Syngene.

In 2023, Syngene added the plant to its biologics network, paying INR 702 Crores ($86 million) and pledging a further INR 100 Crores ($12 million) to convert the facility into a monoclonal antibody manufacturing plant.

Aragen breaks ground on manufacturing facility

In other news, CDMO Aragen has begun the first phase of its biologics manufacturing facility in Bangalore, India. Through its subsidiary, Aragen Biologics Pvt Ltd, the facility will execute its first small-scale manufacturing project for a U.S.-based organization for an anticancer monoclonal antibody (mAb).

In 2023, BioProcess Insider reported that the facility spans over 160,000 square feet and will include process development labs and multiple manufacturing suites with supporting functions like quality control labs for analytical and microbiological purposes.

Announced in 2022, the facility will provide comprehensive solutions ranging from large-scale drug substance (DS) manufacturing, analytical development, pilot production, process development, and validation to stability services and pilot production.