Enzene, a fully integrated CDMO with services spanning discovery, development and commercial supply, today announced it is to launch its new EnzeneX™ 2.0 technology at the CPHI Milan show in Italy. The patented technology is a further evolution of the company’s fully-connected continuous manufacturing™ (FCCM™) platform for commercial biologics supply.

The EnzeneX™ 2.0 platform provides uninterrupted processing, from perfusion to final drug substance. By employing high titer clones, productivity and target protein concentrations are improved, production can be streamlined, and risks associated with batch-to-batch transfers are mitigated. Additionally, EnzeneX™ 2.0 will leverage optimized cell media to boost cell productivity and efficiency, while also incorporating process analytical technology (PAT) to enable real-time monitoring and control for consistent quality and optimized processing.

“Enzene continues to lead the industry in launching innovative approaches to maximize product yield while minimizing COGS. Our latest innovation in fully-connected continuous manufacturing™ can be tailored for a broad range of modalities and media formulations to boost cell productivity and efficiency,” said Himanshu Gadgil, CEO of Enzene. “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.”

First developed at Enzene’s facility in Pune, the EnzeneX™ 2.0 platform reduces the equipment footprint compared with conventional fed-batch systems. It is capable of clinical phase cGMP supply from as low as 30-liter scale, and its modular design with variable bioreactor capacity accommodates scale-on and scale-out expansion. Enzene’s launch of a new state-of-the-art $50-million manufacturing facility in Hopewell, New Jersey, ensures new opportunities for the biotech industry as the company introduces fully-connected continuous manufacturing™ in the U.S. The facility is expected to be fully operational by Q1 2025.