CPHI Milan 2024: Fill/Finish and Sustainability

Large-molecule therapeutic products are being increasingly developed that need to be administered via injection or infusion. As these products enter directly into the blood stream, they must be sterile and free of any potential contamination, which is increasing demand for fill/finish services.

The need for sterile dosage forms is a major change from what was required of manufacturers decades ago, when the key prioritization was on small-molecule drug products, notes Hanns-Christian Mahler, founder and board member of ten23 health. Another driver of growth within fill/finish includes the demand for glucagon-like peptide-1 (GLP-1) medicines, which are absorbing a large proportion of the manufacturing capacity, he adds.

However, regulatory guidance has also undergone revisions, which is having an impact on fill/finish facilities. “From my vantage point, I truly believe in isolator technology,” explains Mahler. “So, that’s where I think an isolator in cleanroom, Class C, is probably where you would want to go if you’re building new facilities. And I think a lot of struggles are ongoing with a lot of folks where, they're trying to actually make upgrades from a filling environment, and that obviously comes with a cost, with a shutdown, and with a potential risk.”

Additionally, regulatory bodies in Europe and around the world are putting greater emphasis on sustainability for facilities; although, Mahler believes there is a need for regulations to be stricter. “[Sustainability] has been a key question … and how we want to operate from a footprint perspective,” he says. In the new ten23 health facility in Visp, Switzerland, for example, the whole façade of the building has been covered in solar panels with photovoltaics, Mahler explains, allowing the company to produce enough energy it can provide the surplus back to the grid.

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ten23 can be found at Booth 18G6. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

About the speaker

Hanns-Christian Mahler holds a PhD in Toxicology from the Institute of Pharmacy at the University of Mainz and is an adjunct faculty member and lecturer at the universities of Frankfurt and Basel. He previously worked for Lonza, Roche, and Merck, and currently serves on the boards of Bionter and KriyaBio. Hanns-Christian is also an editor for several pharmaceutical journals.