Enzene, a pioneer in fully-connected continuous biologics manufacturing technology, announced that ahead of the official opening of its biologics manufacturing facility in Hopewell, close to Princeton in New Jersey, it has expanded its plans for the site. Located in the heart of the Northeast’s biopharma corridor, the site will now incorporate a further 26,000 square feet of drug substance manufacturing suites, laboratories, storage, dispensing and warehousing.

“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.”

As well as conventional fed-batch drug substance manufacturing, the expanded scope of development will make extensive use of the modular EnzeneX™ 2.0 platform, which occupies a smaller footprint than that of conventional systems. The platform, which uses the first fully-connected continuous manufacturing™ (FCCM™) technology, leverages 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. It 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.