CPHI Milan 2024: The Usefulness of Fully Connected Continuous Manufacturing

As part of its CPHI Milan 2024 coverage, Pharmaceutical Technology^® Europe sat down with Himanshu Gadgil, PhD, CEO of Enzene Biosciences, to discuss the concept of fully connected continuous manufacturing (FCCM) and its unique role in automating an entire biologics operation.

“It's a straight-through process which starts from upstream all the way to purified bulk,” Gadgil said in the interview. “And, you know, because there are no hold steps or hold tanks where the process falls or pauses, you know, it's like Netflix without ads, in a sense, right? So, once you have that, it is easier to bring in process analytical tools, it is easier to automate the whole process and start dynamically controlling it.”

Gadgil also talked about the cost-effectiveness of FCCM, especially in terms of equity for biotech companies that may not normally be able to afford these types of services.

“When you do continuous capture, you're continuously bringing it out from this unstable matrix and into a stable buffer,” Gadgil said. “A lot of the newer modalities, such as bi-specific, tri-specific molecules, often tend to be human-engineered. And what I have observed in so many years of doing bioprocess is anything that is human engineered also seems to have some kind of instability associated with it. So, for such kind of molecules, you really don't have an alternative. So, the cost advantage, of course, is huge. I mean, it can be almost a 90% reduction.”

Click the above video to watch the full interview.

Visit Enzene Biosciences at Booth 5D63. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.