Manufacturing professionals in the biopharma sector are currently facing three significant challenges, according to interviews conducted by BioSpace with industry executives. Two of these challenges relate to working with manufacturing providers, while the third concerns regulatory issues.
BioSpace spoke with Rich Kenley, vice president of chemistry, manufacturing and controls at Actuate Therapeutics, and Ryan Pruchnic, managing vice president of Cook MyoSite. Actuate Therapeutics is a biotechnology company based in Fort Worth, Texas that develops therapies for hard-to-treat cancers. Cook MyoSite operates out of Pittsburgh and focuses on technology for collecting and expanding human skeletal muscle cells for regenerative medicine.
One major challenge is finding sterile product manufacturers. Kenley explained that demand for sterile manufacturing capacity has increased sharply due to the introduction of GLP-1 sterile products. "In the sterile manufacturing world, the issue is that the introduction of the GLP-1 sterile products has created such a demand for capacity that it’s squeezing out available capacity for smaller products," he told BioSpace.
Kenley pointed out that large companies like Eli Lilly and Novo Nordisk dominate much of this capacity with their high-demand drugs such as Zepbound, Mounjaro (Lilly), Ozempic, and Wegovy (Novo Nordisk). He also highlighted Novo Holdings’ 2024 acquisition of Catalent—a contract development and manufacturing organization—and subsequent sale of several fill-finish sites to Novo Nordisk as further reducing available service providers for smaller biopharmas.
For startups seeking sterile product manufacturers, Kenley advised engaging with niche providers rather than larger ones: "They may be limited in scale eventually, but they’re still available to take on startup projects."
A second challenge involves deciding where to manufacture small molecule active pharmaceutical ingredients (APIs). Kenley noted that China currently offers the greatest capability and cost efficiency for API production compared to the U.S. or Europe. However, new legislation called the BIOSECURE Act restricts work with certain Chinese firms. The law does not specify which companies are affected; instead, an annual list is published by the Department of Defense after consultation with other agencies.
"So, pharmaceutical developers don’t know what the future holds," Kenley said. "Is a company I’m using today in China to make my API going to be on their list next year? And what do I do about that? There’s solutions always to this problem, but onshoring it takes time and costs money that development-stage companies usually don’t have."
Kenley suggested companies just starting out should avoid manufacturing in China and consider India as an alternative due to its substantial API production capacity. For those already working with Chinese partners, he recommended developing contingency plans such as exploring Indian or U.S.-based options—even though shifting production can be complex because China supplies most starting materials needed globally.
The third challenge relates to regulatory issues. Both Kenley and Pruchnic identified uncertainty stemming from differences between U.S. and European regulations as well as recent changes within U.S. agencies like the FDA following administrative shifts. "The system wasn’t perfect, but at least you more or less knew what it was," Kenley said. "The rules are really in flux right now."
Recent reorganizations at the FDA have led some biopharma companies—including Actuate—to work with new agency contacts mid-process. Regulatory requirements themselves have also shifted; for example, on January 11th the FDA announced relaxed chemistry, manufacturing and control requirements for cell and gene therapies advancing past Phase I trials.
Pruchnic noted ambiguity remains even as regulations catch up with regenerative medicine technologies: "For instance," he wrote in emailed responses to BioSpace, "clear and understandable regulations exist stating you cannot have particles in pharmaceutical products. These same expectations exist in cell therapies, when in fact a cell is a particle in the product. You must then interpret where ‘a certain limit is acceptable’ but there are not always clear directives to follow."
He added that unclear guidelines force companies into repeated experiments and quality system adjustments—an expensive process given how arduous these products are to manufacture.
To navigate regulatory complexities, Kenley recommended hiring expert consultants who regularly communicate with regulators: "Many of these consultants talk to regulators and are therefore close to the issues." Pruchnic emphasized self-advocacy before regulators: "You are the expert of your product," he wrote. "Build processes that you believe in and can defend with science. Then go make a strong argument for why you are right. If you wait to have someone else tell you what is right or wrong, you may be depending on someone that has far less experience on your product than you do."
