Enzene has launched a biomanufacturing model designed to help governments and biopharma companies establish local facilities for producing biologic medicines.

Enzene launches NeX for local biomanufacturing

Enzene has launched NeX, an end-to-end partnership model designed to help governments, institutions and biopharma companies establish local biomanufacturing capabilities.

The programme is built around Enzene’s EnzeneX fully connected continuous manufacturing platform and is intended to support the development of biologics manufacturing facilities closer to patients and regional supply chains.

Enzene said the model is designed to reduce the capital requirements associated with conventional fed-batch biologics manufacturing facilities while supporting local production of biologic medicines.

The company said NeX can provide support across the development and launch of a manufacturing facility, including facility design and build-out, technology transfer and intellectual property licensing for its continuous manufacturing platform.

The programme also includes workforce training through Enzene’s structured training curriculum and operational support during facility start-up and commercialisation.

Where required, participating organisations may also receive access to selected products from Enzene’s biosimilar portfolio for manufacture within their own regions.

Continuous manufacturing could reduce facility costs

Enzene said its fully connected continuous manufacturing approach could significantly reduce the capital required to establish a biologics manufacturing facility compared with conventional fed-batch plants.

“A conventional biologics plant often requires between $300 million and $400 million to build,” Himanshu Gadgil, CEO of Enzene, said. “With our fully-connected continuous manufacturing platform, the same output can be achieved for $60–$80 million.”

Gadgil said the lower cost was linked to the platform’s compact and integrated system architecture, which the company said avoids some of the scale-intensive layouts associated with traditional fed-batch facilities.

“The efficiency comes from a compact, integrated system architecture rather than the scale-intensive layouts of fed-batch facilities, allowing for long-term cost advantage and high product yields for locally manufactured biomedicines,” he added.

The company said the approach could help address the high capital costs associated with building biologics manufacturing infrastructure, while also supporting regional production and potentially improving access to medicines.

Programme targets supply chain resilience

NeX is intended to support countries and organisations seeking to develop domestic biopharmaceutical manufacturing capabilities and reduce reliance on geographically concentrated supply chains.

The programme could also support the development of local scientific and manufacturing expertise through workforce training, while allowing participating organisations to establish production capabilities using Enzene’s continuous manufacturing technology.

Enzene said the model is designed to help regions build more resilient biopharmaceutical supply chains and reduce long-term manufacturing costs for patients.

The company is already in discussions with governments and corporations about the programme, according to Gadgil.

“We are already engaged in discussions with multiple governments and corporations all around the world and are looking forward to helping deliver affordable medicines to patients worldwide,” he said.

Enzene estimates that facilities established through the NeX programme could reach validation and commercial readiness in under three years.

The launch comes as biopharmaceutical manufacturers and governments continue to explore ways to strengthen domestic production capabilities and improve the resilience of medicine supply chains.

For biologics, manufacturing infrastructure can require significant investment, while production processes are often complex and highly regulated. Enzene’s model is therefore aimed at organisations looking to establish local manufacturing without investing in the scale of a conventional facility.

The company said NeX is designed to make its continuous manufacturing technology and associated expertise available to organisations seeking to develop regional biologics manufacturing capabilities.