Enzene on Proving Its Continuous Platform by Launching Its Own Biosimilars

Enzene, a biologics contract development and manufacturing organization (CDMO) and a subsidiary of India's Alkem Laboratories, runs a fully connected continuous manufacturing platform it calls EnzeneX, which wires the upstream straight through to the downstream as far as the third chromatography column.

Shilpa Gadgil, VP for Bioprocess Development, set out the company's decade-long push to normalize the technology in a sit-down interview at Sartorius's Process Intensification Forum, held in Hyderabad from June 2-4, 2026. “It's not a pilot, it's a market reality today,” she said, pointing to the four biosimilars Enzene has commercialized itself in India using the platform.

Perceived risk

“Initially we faced a lot of resistance,” Gadgil said. “There was not enough acceptance.”

Prospective clients wanted to know why, if fully connected continuous manufacturing (FCCM) worked, the large pharmaceutical companies had not adopted it. The answer, she argued, sat in their plants rather than their labs, as incumbents were tied to legacy equipment and legacy facilities they could not simply write off.

What Enzene was really up against was “fear of uncertainty, fear of the unknown, fear of getting out of your comfort zone.”

So, she explained, Enzene built the evidence in-house. It developed its own biosimilar pipeline, took the products to market, and let the results speak.

“The proof is in the pudding,” she said. “The process works and they have seen it time and again.”

Regulatory acceptance

Regulatory acceptance followed a similar curve with agencies being wary at first, unsure how to define a batch in a continuous process or what to do if quality drifted over a long run.

However, Gadgil said, the data won them over. “Now they are very, very open to continuous manufacturing.”

She credited the arrival of the International Council for Harmonization’s Q13 guideline on continuous manufacturing, adopted in November 2022 and taken up by the FDA the following year, and said India's regulators were now catching up. Other speakers at the same forum were less sanguine, flagging the continued absence of India-specific guidance on how to actually file a continuous process.

Driving the cost down

Each version of Enzene’s platform is built to push cost of goods sold (COGS) lower in service of what Gadgil called affordable medicine. EnzeneX 1.0 carries the four commercial products.

EnzeneX 2.0, where the company sits now, scales the process from 160 L to 1,000 L and moves to higher-titer clones, targeting a fall from $90 to $40 per gram of product. Version 3.0, due next year, folds in process analytical technology (PAT) through a collaboration with the US National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) and Rutgers University, run at Enzene's Hopewell, New Jersey site, for real-time monitoring and fewer failed batches.

The longer target is the $10 a gram that the Gates Foundation and LifeArc set out in 2025 for their low-cost antibody challenge, against a market price stuck at roughly $50 to $100. Enzene is working with the Foundation on the same platform. The Foundation does not insist the figure be hit in the US, Gadgil noted, and while India's cheaper labor lowers development and manufacturing costs, intensification does the real work.

“If you had to take head-to-head fed-batch process in the US and then the FCCM process in the US, the COGS are going to be down for FCCM anytime.”