Enzene announced expanded plans for its biologics manufacturing facility in Hopewell, New Jersey.  This comes ahead of the official opening. 

The site will now incorporate a further 26,000 square feet of drug substance manufacturing suites, laboratories, storage, dispensing, and warehousing.

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 uses the first fully-connected continuous manufacturing (FCCM) technology and 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 a 30-liter scale, with variable bioreactor capacity to accommodate scale-on and scale-out 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.”