Contract development and manufacturing organisation (CDMO) Enzene has expanded its plans for its new US biologics manufacturing facility in Hopewell, New Jersey.
Following this announcement, the company has committed to incorporating a further 26,000 sqft of drug substance manufacturing space.
This will include manufacturing suites, laboratories, storage, dispensing and warehousing.
The site is anticipated to open later this year, though it is already producing non-GMP batches — with demand rising from US-based small and medium-sized biotech companies.
“With construction already well advanced, it made sense to seize the opportunity to add to the 54,000 square feet we had already planned," noted Norm Stoffregen, SVP and site head at Hopewell.
"This meant that we could include additional capacity, larger dedicated quality control and development laboratories and the space we will need for materials and finished goods," he added.
Located in the Northeast's biopharma corridor, the site is Enzene's first direct foray into the US market, offering end-to-end, continuous biologics manufacturing services to its North American clients.
As well as conventional fed-batch drug substance manufacturing, the expanded scope of development will make use of the EnzeneX 2.0 platform, which has a smaller footprint than conventional systems.
The platform uses the first fully-connected continuous manufacturing technology — leveraging optimised cell media to boost cell productivity and efficiency, while incorporating process analytical technology (PAT) to enable real-time monitoring and control.
The system is also capable of clinical-phase GMP supply from as low as a 30L scale, with variable bioreactor capacity to accomodate scale-on and scale-out expansion.
“We will officially open our site later this year, but we're already producing non-GMP batches and seeing strong demand from US-based small- and medium-sized innovators as we look ahead to GMP readiness,” stated Stoffregen.
"We look forward to inaugurating this further capacity," he concluded.
