Continuous biopharmaceutical manufacturing is expected to grow as much as 17% between now and 2033, according to multiple industry analysts, thanks to its ability to improve efficiency, enhance quality, and reduce costs when compared to batch processing. For manufacturers, implementation can be a fully continuous model, or a hybrid approach that gradually phases in continuous processing while leaving some processes distinctly separate.
Enzene, a global contract development and manufacturing organization (CDMO), is one of the first to offer fully connected continuous manufacturing (FCCM™) technology. FCCM’s modular approach enables manufacturers to evolve their processes to a fully continuous model gradually, linking and automating sections at a time while still running other sections of the process traditionally.
Using this system, Himanshu Gadgil, PhD, CEO of Enzene, says, “In 2025, we hit our stated target to achieve monoclonal antibody (mAb) production costs of less than $40 per gram.”
For context, other continuous processing methods average $80 to $100 per gram, while fed-batch processes may range from $150 to $300 per gram, according to Russell Miller, Enzene’s vice president of global sales and marketing.
Commercial biologics validation
Enzene’s recent claim to fame is its modular, FCCM-powered EnzeneX™ platform. With that platform, Enzene won the 2025 CPHI Pharma Award for Manufacturing Excellence last October. EnzeneX is considered to be the first truly fully connected continuous manufacturing technology to be validated for commercial biologics applications. So far, four mAbs have been commercialized using FCCM technology, including, most recently, pertuzumab.
Because FCCM technology is modular, it also can run as a semi-continuous hybrid system in which only certain elements operate continuously. An example would be to run protein capture continuously, but halt before running other downstream steps. Such modularity helps companies retrofit continuous components into their existing batch processes.
“The platform is fully connected from bioreactor to pre-drug substance, with everything happening simultaneously in continuous mode,” Gadgil says. Yield is tenfold greater than conventional batch manufacturing, which supports savings—in terms of cost of goods sold—as high as 40 to 50%, “even for complex molecules.”
“Traditionally,” Miller elaborates, “biologics manufacturing requires multiple large bioreactors operating in sequence, often involving up to six massive tanks and consuming substantial space, capital, and time, and introducing operational risks. With FCCM technology, however, fresh media is continuously fed into cell cultures, linking reaction, separation, and purification into a single streamlined process.”
“This approach maximizes reactor utilization and increases output by using optimized cell media and process analytical technology,” he says. “This significantly reduces costs and minimizes risks.” Furthermore, FCCM’s modular technology supports ready scale-up.
Miller points to an FCCM footprint that he says is 70% smaller than that of comparable batch cultures. That, combined with the ability to use a smaller clean room, reduces the carbon footprint per gram of protein produced.
From India to New Jersey
Enzene was formed in 2015 in Pune, India, as a clone-to-formulation facility and clinical manufacturing facility. By about 2020, coincidental with the outbreak of the COVID-19 pandemic, its operations morphed to include CDMO operations.
Since then, much of its early-stage biologics work—especially around Phase I manufacturing—has been for U.S.-based companies. “Many potential clients expressed a preference for a local partner to avoid time-zone friction, supply chain complexity, and post-COVID operations risks,” Gadgil recalls. Therefore, the company began planning for U.S.-based operations.
Even without that stated preference, the U.S.—a leader in early-stage biologics innovation with a dense concentration of innovative companies—was an attractive market. Increasing interest in reshoring biomanufacturing to the U.S. accelerated the timeline, Gadgil admits, “but building a presence in the U.S. was already a long-term, client-led decision that aligned with where biologics development is happening fastest today.”
Enzene opened its first U.S. facility in New Jersey in September 2025. The 80,000 square-foot manufacturing center features the EnzeneX platform and the FCCM technology.
“Now that it has established operations in the U.S., Enzene will turn to anchoring the business,” Gadgil says. “We expect to significantly expand our U.S. manufacturing capacity over the next few years in support of a growing deal funnel across a broad range of biomodalities.”
Small innovators and big pharma
Enzene works with clients of all sizes, the company is quick to underscore.
“Many large CDMOs operating with 10,000–20,000-liter capacities prefer working with big pharma,” Miller acknowledges, “but early-stage companies often struggle to find the right partner, especially one that is local. That’s where we provide solutions.” Rapid onboarding for early-stage clients is a major differentiator, he points out. He stresses the flexibility that comes from modularity and the ability to right-size manufacturing “for clients from early-stage supply to commercialization.”
Big pharma is becoming particularly interested. “We are in discussions with several top 10 pharma companies,” Miller says. “So, while early-stage companies will stay an important segment, our platform’s flexibility, scalability, footprint advantages, and efficiency appeal strongly to large pharma as well, and interest is growing rapidly.”
Challenges equal opportunities
The health of the biotech industry is generally good, even though sales margins face increasing pressure. In such an environment, Miller suggests, there are opportunities for companies of all sizes to leverage the EnzeneX platform to enhance biomanufacturing efficiency and thereby lower costs.
He also says that flexible manufacturing platforms can help overcome challenges in a still-fractured global regulatory environment. Specifically, Miller emphasizes the ease of advancing programs from lab to commercial scale while maintaining batch consistency and adherence to good manufacturing practice standards.
Enzene also has developed another revenue stream, manufacturing therapeutics for both human and animal health markets. “Animal health is a logical adjacency to our core capabilities,” Miller emphasizes.
In terms of maturity, the animal health market is at the point human biotherapeutics were at ten years ago, Miller says. “Now there’s huge potential for that segment to make giant leaps in supply models through the use of modern bioprocessing technologies.”
The science-first concepts Enzene espouses, coupled with deep biologics expertise, regulatory discipline, and manufacturing platforms designed expressly for flexibility, scalability, productivity, and cost efficiency, “apply just as well to the animal health market as to the human health market,” Miller reiterates. He suggests the current gap between market demand and manufacturing infrastructure for animal health products offers an opportunity.
Continual improvement
Having just completed an international expansion, it would be unremarkable for a company to pause to grow into its new market. With Enzene, this is not the case.
“We are not content to stand still,” Gadgil says. “We are well-advanced in our efforts to bring a new generation of the EnzeneX platform to market. The key point for us is that achieving these cost and efficiency improvements is not a one-off outcome; it’s a repeatable, scalable cost structure built into the platform.
