Enzene launches EnzeneX™ 2.0 technology for biologics at CPHI Milan 2024

New Delhi: Enzene, a leading contract development and manufacturing organization (CDMO), has announced the launch of its latest innovation, EnzeneX™ 2.0, at the upcoming CPHI Milan show in Italy. The new platform represents an advanced iteration of its patented Fully-Connected Continuous Manufacturing™ (FCCM™) technology, designed to enhance the commercial production of biologics.

EnzeneX™ 2.0 offers uninterrupted processing, from perfusion to the final drug substance stage, utilizing high-titer clones to significantly improve productivity and target protein concentrations. By streamlining production and reducing risks associated with batch-to-batch transfers, the new technology aims to minimize costs while boosting efficiency. In addition, EnzeneX™ 2.0 integrates optimized cell media and Process Analytical Technology (PAT), allowing real-time monitoring and control for consistent quality output.

“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.

He added, “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 Pune facility, the EnzeneX™ 2.0 platform is also highly adaptable. It features a modular design and variable bioreactor capacity, accommodating scale-on and scale-out expansion, making it suitable for clinical phase cGMP supply as small as 30 liters. Moreover, it significantly reduces equipment footprint compared to traditional fed-batch systems.

As part of its expansion into the U.S. market, Enzene is launching a $50-million manufacturing facility in Hopewell, New Jersey, set to be operational by Q1 2025. This state-of-the-art facility will further promote the adoption of continuous manufacturing technologies in the American biotech industry.

Enzene will showcase EnzeneX™ 2.0 at CPHI Milan from October 8–10, 2024, at stand 5D63, Hall 5, Fiera Milano, Italy. The event will highlight the company’s commitment to innovation and its impact on biologics manufacturing on a global scale.