India-headquartered contract development and manufacturing organization Enzene has announced that it has expanded plans for its biologics manufacturing facility in Hopewell, New Jersey, near Princeton, which will officially open later this year.
The site will now incorporate an additional 26,000 square feet of drug substance manufacturing suites, laboratories, storage, dispensing and warehousing.
“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,” Norm Stoffregen, Enzene senior vice president and site head at Hopewell, said in a statement.
In addition to conventional fed-batch drug substance manufacturing, Enzene said the expanded scope of development will make extensive use of the CDMO’s modular EnzeneX 2.0 platform, which the company contends 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,” according to Enzene, which said 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.
In March, Enzene secured European Union (EU) Good Manufacturing Practice (GMP) certification for its two facilities in Pune, India, allowing the company to supply microbial and mammalian drug substances — as well as drug product fill-finish and packaging — for commercial use in the EU markets.
The certification confirmed compliance with the European Medicines Agency’s (EMA) quality and safety standards and enabled Enzene to expand its reach in global biologics manufacturing.