Exploring Current Trends and Purification Innovations (CPHI Milan 2024)

Editor's note: this interview was originally published on PharmTech.com.

Stacey Treichler, senior director of global marketing and strategy for the Purolite resin business at Ecolab, spoke with the Pharmaceutical Technology Group during CPHI Milan about current trends in resin technology and purification in bioprocessing. Some current trends include the increasing complexity of drug modalities, the growing number of biosimilars coming onto the market, and increasing focus on security of supply, Treichler said.

To give some examples on the trend in complex modalities, Treichler pointed out antibody-based therapies: “You might be talking about a bispecific or multi specific [antibody], or a really complex fusion protein. It's been really exciting to see the increasing complexity, because what that's doing is enabling drug development companies to address unmet need. And of course, that's what we're all striving to do—help address those unmet needs.”

However, the flip side of increasingly complex modalities is that these complex drugs can have much more complex challenges associated with manufacturing, Treichler noted. “Those developers can run into some issues when they're trying to develop a scalable, robust manufacturing process,” she said. For biosimilars, Treichler said that there is a large number of biosimilars coming into the pipeline and being launched onto the market. “Again, very exciting, because biosimilar developers are able to get those drugs to the market at a lower cost many times, which makes it more accessible to more patients. But a challenge that comes from that is trying to improve your manufacturing efficiencies and keep your costs down so that you can pass along those lower costs to the patient and, broader, in the industry,” she explained. “So, biosimilar developers are faced with that challenge of, how do I make my drugs more cost effectively?”

“Finally, security of supply and business continuity is top-of-mind coming out of the pandemic,” Treichler said. “I think what pharma developers have realized is you definitely cannot take your supply chain for granted. So, they're looking at, how can they dual source, or even triple source, critical materials into their manufacturing process? But they're also looking at, globally, where is the manufacturing happening, and what's my strategy in the global network to basically improve my business continuity? Businesses are definitely taking a more focused effort in that area.”

In terms of innovation in resin technology, Treichler said that there are few major areas of focus: complex complex modalities, binding sites, and improving cost of goods. “The manufacturing process can be harsh on [complex modalities]. When you treat those drugs with low pH, harsh chemicals, harsh conditions, they may aggregate, they may lose their folding, and they might not display the critical quality attributes that drug developers are looking for coming out of the manufacturing process,” she explained.

As for binding sites, Treichler pointed out that not every antibody has all of the typical components of a traditional antibody, so an affinity resin may be needed that binds somewhere else on the antibody to allow for purification. Meanwhile, improving cost of goods is prompting innovation in resin technology. Resins are also subject to harsh biomanufacturing conditions; low pH cleaning solutions, proteases, or other things coming out of the cell being purified and to which the resin is exposed can chew up the resin and impact its ability to bind. Some innovations being developed are trying to improve the durability of the resin so that they can go through more cycles, and, ultimately, drug developers can achieve productivity and reduce their cost of goods, according to Treichler.

Click above for the full interview.

Visit Ecolab at Booth 3D46 in Hall 3. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.