An Interview With...
Rod Ketner, PhD
Vice President of Business Operations
Serán
If you were speaking to a pharma or biotech team evaluating Serán as a partner, how would you explain what the Bend expansion changes for them in practical terms?
It gives clients greater continuity in advancing their medicine. We’ve built Serán to carry scientific understanding from formulation through clinical manufacturing and now further into commercial readiness. That means fewer handoffs, less redevelopment, and a more efficient path for complex products to market.
For customers, the real benefit is not just added capacity. It’s the ability to translate early technical decisions into scalable manufacturing and supply execution.
Serán often emphasizes a “Right-From-the-Start” development model and an engineering continuum from early formulation through commercial readiness. How does that approach reduce risk for customers as programs scale?
The biggest risk in development is making early decisions that don’t hold up later, requiring expensive and time-consuming re-formulation and BE studies. Our approach is to think about commercial relevance from the beginning, understand target product profile, define the right formulation strategy for the molecule, and build the process with scale in mind.
That reduces the need for reformulation, tech-transfer friction, or late-stage delays.
Which capabilities or equipment in the expanded site most meaningfully broaden what Serán can do for clients?
What matters most is the combination of enabling technologies alongside finished-dose capability. We’re offering commercial-scale spray drying, fluid-bed processing, granulation, tableting, coating, encapsulation, and powder filling, supported by packaging and supply-chain operations.
That breadth is important because our clients need integrated solutions, not isolated unit operations. The more tightly those capabilities work together, the more effectively we can support complex oral drug products at scale.
Many CDMOs are adding capacity right now. What truly differentiates Serán and this expansion from a conventional capacity build-out?
This is not JUST a capacity story. Capacity is important, but clients ultimately choose a CDMO for scientific depth, technical judgment, quality and execution.
Serán’s model has always been science-first. The expansion extends that core strength into larger-scale and commercially relevant manufacturing. What differentiates this expansion is that it is built around advanced formulation and particle-engineering expertise, not the other way around.
What are you personally most excited about in this next chapter for Serán, and what should customers be most excited to see over the next few years?
I’m most excited about helping clients bridge a gap that has historically been difficult in our industry: moving from strong development work into reliable late-stage and commercial execution without losing momentum.
Customers should be excited to see a partner investing in the full continuum of formulation and engineering science, manufacturing, packaging, and supply-chain support needed to bring complex medicines to market efficiently and with confidence.
Molecules are becoming more complex, and bioavailability challenges are not getting easier. How is Serán evolving its technology selection strategy so clients choose the right enabling approach earlier?
We start with the molecule and the TPP and let the science guide the strategy. Complex compounds often need enabling approaches such as spray dried dispersions, hot melt extrusion, particle engineering, or modified-release design to enhance bioavailability, but there is no universal answer.
The key is to make the right choice early, with scalability in mind. Our job is to use experience, data, materials science, and dosage form expertise to identify the approach that is both technically effective and commercially viable.
As companies move from early clinical work into pivotal studies and commercial supply, where do you see sponsors most often underestimating tech-transfer or validation risk?
Sponsors sometimes optimize too narrowly for the next milestone instead of the full development path. A formulation may be sufficient for an early study but still be poorly positioned for robust scale-up, transfer, or validation.
That’s where delays and added costs show up. Serán believes the best way to reduce that risk is to define critical product and process ranges & requirements early and generate development data that will be leveraged later.
AI and advanced modeling are receiving a lot of attention in formulation and process development. Where do you think data science can create real value, and where does expert judgment still matter most?
Data science can create real value when it improves process understanding, speeds learning, and helps teams make better decisions earlier. It is especially useful in experimental design, modeling, and identifying scale-up risk.
But formulation remains a physical science. Materials behavior, manufacturability, and dosage-form performance still require experienced scientific judgment. The future is not automation replacing expertise, it’s better tools strengthening expert decision-making. At Serán we are implementing AI tools strategically, utilizing process modeling and data science to enhance and accelerate the work our teams are already doing today.
Sustainability is becoming a bigger conversation across pharmaceutical manufacturing. How do you think about process efficiency and environmental responsibility without compromising speed or quality?
For us, one of the most meaningful forms of sustainability is improved development efficiency. If you use less API, reduce failed iterations, and avoid unnecessary reformulation, you improve speed, cost, and resource use at the same time.
In that sense, good science is also good stewardship. The more efficiently you solve the technical problem, the better the outcome across the board.
Rod Ketner, Ph.D. is Vice President of Business Operations at Serán BioScience where he focuses on the business of science; bringing value to clients with drug delivery technologies and delivering their medicines to patients. His responsibilities include leading Serán’s business development, marketing, and project management teams, and overseeing Serán’s portfolio of new client medicines. He has nearly three decades of pharmaceutical drug product expertise and business development leadership experience. In his early career at Bend Research, he contributed to innovations in spray-dried dispersion (SDD) formulations and stability resulting in inventorship on more than 18 drug delivery patents. He holds a Ph.D. in Physical Organic Chemistry.