Enzene Introduces New Continuous Manufacturing Tech for Biologics

The platform also incorporates optimized cell media to boost cell productivity and includes process analytical technology (PAT) to monitor and control production in real-time.

Enzene, a contract development and manufacturing organization (CDMO), has unveiled its latest advancement in biologics manufacturing technology, the EnzeneX 2.0 platform. 

The EnzeneX 2.0 platform is an evolution of Enzene’s fully connected continuous manufacturing (FCCM) system. It aims to streamline biologics production by offering uninterrupted processing from perfusion to the final drug substance. 

One of the platform's key features is the use of high-titer clones, which enhance productivity and improve the concentration of target proteins. This, in turn, reduces production costs and minimizes the risks associated with batch-to-batch transfers. 

The platform also incorporates optimized cell media to boost cell productivity and includes process analytical technology (PAT) to monitor and control production in real-time. This enables consistent quality and efficiency throughout the manufacturing process.

Himanshu Gadgil, CEO of Enzene, said, “Lower operational costs and higher productivity can enable up to 50% reductions in overall production cost per gram, and we are on target to achieve a game-changing benchmark by 2025. We expect that our FCCM will be able to deliver 40 kilograms per thousand-liter batch at $40 per gram.”

About EnzeneX 2.0 platform

Developed at Enzene’s Pune facility, the EnzeneX 2.0 platform reduces the equipment footprint and improves scalability. Its modular design and variable bioreactor capacity accommodate both scale-on and scale-out expansion, making it adaptable for various production sizes. 

The system can provide clinical phase cGMP (current Good Manufacturing Practice) supply, starting from as low as a 30-litre scale. 

Enzene’s investment in continuous manufacturing includes the construction of a new $50 million facility in Hopewell, New Jersey. The state-of-the-art facility is designed to bring Enzene’s FCCM technology to the US market. 

The facility is expected to be fully operational by the first quarter of 2025, offering fresh opportunities for the biotech industry.

The EnzeneX 2.0 platform is set to further reduce the equipment footprint compared to conventional fed-batch systems. Enzene hopes to optimize the biologics supply chain while addressing industry demands for higher productivity and lower costs by allowing for uninterrupted processing and greater operational flexibility. 

“Our focus is on improving both cost-efficiency and productivity, and we are confident that this technology will set new standards in biologics manufacturing,” CEO Gadgil noted.

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