CDMO Just-Evotec says the recent sale of a France bioproduction facility to the world’s largest biosimilars maker has validated its continuous processing tech, and is now offering the end-to-end platform to the wider industry.

The contract development and manufacturing organization (CDMO) recently showcased its continuous manufacturing platform, J.Train, to third parties at Interphex in New York in a presentation titled “Economical, Faster, Flexible: A Blueprint for Biological Manufacturing.”

“We have built a fully end-to-end continuous intensified manufacturing process, and we have designed facilities to run these processes in,” said Lisa Connell-Crowley, SVP of Process and Product Design at Just-Evotec, ahead of the talk. “And now we want to offer that capability to anybody who’s interested. We can put it in your facility, we can build you a facility, and it would include all the continuous manufacturing capabilities and everything that we’ve built.”

The platform uses 500–2,000 L single use perfusion bioreactors that maintain cells at high density through continuous feeding and harvesting, rather than conventional batch cultivation.

“I think for more mature products like antibodies and antibody-like molecules, where the processes are actually pretty well thought out, everybody’s using pretty much the same technology,” Connell-Crowley said. “Now the push is to try to intensify it, shrink it down to a smaller footprint so that you can do it more cheaply.” The set-up also allows companies to rapidly expand capacity to suit market demands, she added.

Fully continuous processes have a much higher productivity of output, Michael Holligan, Director of Capital Projects at Just-Evotec, continued, adding, “We can output produce 10 times from a typical fed batch process on a 500 L bioreactor.”

Just-Evotec has been running a J.Train in its 130,000 square-foot J.POD facility in Redmond, Washington, and a facility in Toulouse, France, which the company recently sold to biosimilars manufacturer Sandoz in what Holligan described as proof of concept for the J.Train business model.

“We have built a facility that implements this J.Train approach and have sold it to Sandoz, and they’re running that facility. That was the last step to kind of prove that, hey, we can do this and we can do it quickly,” he said. “We basically just want to get the message out now that we have this offering—it is maybe not quite what we had originally pushed with the J.Pod approach, but we can do the facility or just the train, which I think provides a little bit more flexibility in what we can offer in terms of scale.”

Connell-Crowley added the Sandoz sale has further validated the platform. “[Sandoz] is the world’s largest biosimilar company, and they want to manufacture really low-cost biosimilars for the world—they have really embraced this technology and that is very, very exciting for us.”

Interest in adopting continuous bioprocessing has been rising for years, driven in part by the precedent set in small molecules, where regulators including the FDA have actively encouraged the transition.

“Based on the success of what’s been happening in the small molecule area, regulatory agencies are actually also saying they want it for biologics,” said Connell-Crowley. “Based on the costs and efficiency, sometimes the product quality is better. They’re really pushing the biologics industry to move in this direction.”

Equipment and technology suppliers have been laying the groundwork. Sartorius, whose portfolio spans single-use bioreactors, perfusion systems and downstream processing technology, has been among the companies investing heavily in the continuous bioprocessing infrastructure that platforms like J.Train depend on.

But bottlenecks still exist, said Connell-Crowley. “One of the more challenging aspects that we’ve been working on for quite a while is the automation to string all of it together. What we’re running is basically batch unit operations but connected together to make it continuous. But the automation to put all that together is our special sauce of how we’ve done it, and others are now doing it too.”

Dan Stanton is a journalist with 15 years’ experience covering bioprocessing and biomanufacturing. He currently works as an editorial expert at Sartorius.