Enzene Set to Unveil Continuous Manufacturing Technology at CPHI Milan 2024

Enzene, a leading contract development and manufacturing organization (CDMO), is poised to launch its cutting-edge fully-connected continuous manufacturing platform for biologics at the upcoming CPHI Milan show, scheduled for October 8–10, 2024, in Milan, Italy. The EnzeneX 2.0 platform represents a significant advancement in manufacturing technology, featuring a patented design that facilitates uninterrupted processing throughout the entire production cycle, from the initial perfusion stage to the completion of the final drug substance. This innovative approach aims to enhance efficiency and reliability in the production of biologics, showcasing Enzene's commitment to advancing biopharmaceutical manufacturing.

The EnzeneX 2.0 technology utilizes high titer clones to enhance productivity and optimize target protein concentrations, streamlining the production process while reducing risks related to batch-to-batch transfers. Additionally, the platform increases cell productivity by employing optimized cell media. To ensure quality control, it incorporates process analytical technology, which allows for real-time monitoring and management of production parameters.

Enzene remains at the forefront of the industry by introducing innovative strategies to enhance product yield while reducing cost of goods sold (COGS),” stated Himanshu Gadgil, CEO of Enzene, in a press release. “Our latest advancement in fully connected continuous manufacturing can be customized for a wide array of modalities and media formulations, significantly improving cell productivity and operational efficiency. This approach could lead to reductions of up to 50% in overall production costs per gram, and we are on track to set a groundbreaking benchmark by 2025. We anticipate that our FCCM will achieve a capacity of 40 kilograms per thousand-liter batch at a cost of $40 per gram.”

According to the company, EnzeneX 2.0 also offers the advantage of a smaller equipment footprint compared to traditional fed-batch systems. It can manage clinical-phase supplies under current good manufacturing practice (cGMP) starting from a 30-liter scale. The platform features a modular design that allows for adjustable bioreactor capacity and supports both scale-up and scale-out expansions, making it versatile for various production needs.

Enzene is preparing to launch a new facility in Hopewell, NJ, which is anticipated to begin operations in early 2025, offering a fully connected service to its clients. “Enzene Biosciences is thrilled to establish our manufacturing operations in New Jersey, as it allows us to enhance our local manufacturing capabilities for our valued North American clients,” stated Gadgil during the facility announcement. “We are eager to provide them with access to our cutting-edge continuous manufacturing platform, which streamlines and improves production processes. New Jersey’s highly skilled workforce, advanced infrastructure, and prestigious academic institutions make it an ideal location for Enzene, ensuring that we can offer exceptional services and robust support to our clients across the United States.” This new facility is expected to significantly boost Enzene's capacity to meet the growing demands of the biopharmaceutical industry.