Enzene, a pioneer in continuous biologics manufacturing technology, has announced a significant expansion of its upcoming biologics manufacturing facility in Hopewell, New Jersey, adding 26,000 square feet to the originally planned 54,000 square feet before the site's official opening later this year.
The expansion will incorporate additional drug substance manufacturing suites, laboratories, storage, dispensing and warehousing capabilities at the facility located in the heart of the Northeast's biopharma corridor near Princeton.
Strong Market Demand Drives Expansion
"We will officially open our site later this year but are already producing non-GMP batches and seeing strong demand from U.S.-based small- and medium-sized innovators as we look ahead to GMP readiness," commented Norm Stoffregen, SVP and site head at Hopewell. "With construction already well advanced, it made sense to seize the opportunity to add to the 54,000 square feet we had already planned, so that we could include additional capacity, larger dedicated quality control and development laboratories, and the space we will need for materials and finished goods."
Advanced Manufacturing Technology Platform
The expanded facility will feature both conventional fed-batch drug substance manufacturing and extensive use of Enzene's modular EnzeneX 2.0 platform, which occupies a smaller footprint than conventional systems. The platform utilizes the first fully-connected continuous manufacturing (FCCM) technology, leveraging optimized cell media to boost cell productivity and efficiency.
The EnzeneX 2.0 platform incorporates process analytical technology (PAT) to enable real-time monitoring and control for consistent quality and optimized processing. The system is capable of clinical phase GMP supply from as low as 30-liter scale, with variable bioreactor capacity to accommodate scale-on and scale-out expansion.
Cost Reduction Goals
As part of its mission to disrupt the existing biologics manufacturing paradigm, Enzene is committed to pushing the boundaries of biologics manufacturing innovation and is striving to reduce monoclonal antibody production costs to below $40 per gram by 2025.
The company operates as a fully integrated, end-to-end CDMO with services spanning discovery, development, and commercial supply, operating integrated sites in Pune, India and New Jersey, USA. Enzene partners with innovators and biosimilar developers to deliver accelerated time-to-market, increased production yields, and cost reductions across a broad range of biologic modalities.
