Enzene opens its first US biomanufacturing site, touts continuous manufacturing capabilities

Indian contract development and manufacturing organization Enzene has officially opened its 80,000 square-foot biologics production facility in Hopewell, New Jersey, near Princeton. The site, the CDMO’s first plant in the United States, includes drug substance manufacturing suites, laboratories, storage, dispensing, and warehousing.

The Hopewell facility features what the company contends is the first fully connected continuous manufacturing technology — the EnzeneX 2.0 platform, offered as an alternative to traditional batch processing and designed to produce high-quality biologics with increased precision and efficiency as well as lower cost of goods.

The platform incorporates process analytical technology (PAT) to enable real-time monitoring and control for consistent quality and optimized processing, according to Enzene.

“We’ve successfully taken our first trial batch and we’ve manufactured four kilograms of material in just 200 liters,” Enzene CEO Himanshu Gadgil said at Wednesday’s opening ceremony for the biomanufacturing plant. “With a conventional process, you need at least 2,000-liter capacity to do this. We’ve done it in 200 liters.”

When Enzene eventually runs the process “full throttle” at the Hopewell site, Gadgil claims the CDMO “should be able to get around 15 to 20 kilograms from 400 liters,” which typically requires up to a 5,000-liter bioreactor capacity. The facility is expected to go into commercial manufacturing as early as 2027.   

Gadgil also noted that the modular EnzeneX 2.0 platform occupies a smaller footprint than that of conventional fed-batch systems and integrates the full production process, from bioreactor to downstream purification in a seamless flow.

“In this small room we can manufacture tons of product in a year, which otherwise you’d need a manufacturing facility as big as this whole campus to achieve,” Gadgil said.

Russ Miller, vice president of global sales and marketing at Enzene, called the Hopewell site “one of the most advanced biologics manufacturing facilities in the U.S.” Initially, the CDMO’s plant will target the antibody-drug conjugate market and later cell and gene therapies, according to Miller.

“We consider ourselves pioneers,” Miller said. “We’re on EnzeneX 2.0 — 3.0, 4.0, 5.0 it’s all already in the plan.”  

Made in America

Enzene’s Chairman of the Board Sandeep Singh said at the opening ceremony that Hopewell “is our first plant in the U.S., not the last,” while noting that the plant “represents long nights, problem solving, setbacks overcome, and dreams turned into reality.”

The Hopewell site, which is several years and $50 million in the making, was planned by Enzene long before President Donald Trump’s threatened tariffs on pharmaceuticals. Singh called it “lucky” that the CDMO now has U.S. manufacturing capabilities amid trade tensions.

New Jersey Governor Phil Murphy, who was at the grand opening of the facility, called Enzene “one of India’s most promising bio technological companies” which he noted is “placing its first bet in America” amid a “challenging” geopolitical environment.

Murphy said the relationship between New Jersey and India is “now as important as it has ever been,” particularly when it comes to attracting Indian life sciences and biopharma companies. New Jersey’s “deep ties” to India are part of an ongoing initiative, according to Murphy, who will lead an economic mission to the South Asian country later this month.

“The manufacturing that we’re talking about in our state in this century, in this moment in time, is embodied by Enzene — it’s advanced and highly sophisticated,” Murphy said. “That’s exactly our sweet spot.”  

Despite macroeconomic and biotechnology funding headwinds, New Jersey remains a hot life sciences hub. According to the New Jersey Economic Development Authority, the state is home to the headquarters or major facilities of 14 of the world’s largest biopharmaceutical companies, employing 115,000 people, and including more than 400 biotech companies.

Debbie Hart, president and CEO of trade association BioNJ, said on Wednesday that the opening of Enzene’s biomanufacturing facility is a “big moment” for New Jersey’s life sciences ecosystem. As a fully connected continuous manufacturing platform, Hart said EnzeneX represents the “forefront” of biologics production “further cementing our state’s position as a national and global leader in biopharmaceutical innovation.”

While the biopharma industry has been slow to adopt continuous manufacturing, it appears to be gaining momentum. Gadgil emphasized that Enzene is “one of the first movers” to develop a “fully connected” continuous manufacturing process, which he called the future of biomanufacturing.

“The whole process is automated, and it runs continuously,” Gadgil said. “Eventually, we want to have very few humans actually being involved in running the process.”

Currently, Enzene’s Hopewell facility employs around 50 people. Ultimately, the company expects to create 200 to 300 jobs at the site.