Dosage Form Innovations: A CPHI Frankfurt Conversation with Lonza’s Frank Romanski, Part One

As part of its coverage of CPHI Frankfurt 2025, Pharmaceutical Technology® Group spoke to Frank Romanski, PhD, vice-president of Strategic Growth & Revenue Management and head of Global Pharma Solutions at Lonza Capsugel. Romanski’s presentation at the conference, “From Molecule to Market: Scalable Enteric Solutions for Accelerated Clinical and Commercial Success,” was delivered on Wednesday, Oct. 29, 2025.

In the first part of this interview, Romanski tells PharmTech Group that while the field of oral dosage forms has not grown as fast in recent years as biologics and cell and gene therapy, he foresees an imminent change in the direction and popularity of oral delivery.

“Simple fact, adults don't like [using] needles,” Romanski says in the interview. “Children don't like [using] needles. Eighty-four percent of biologics are actually parenterally administered, and about two-thirds of people that take pharmaceuticals really, really despise the needles. And in fact, there are very large fractions of the population that will just avoid it entirely.”

However, he cautioned, formulation challenges remain, and those must be reckoned with in a number of different ways—due to distinct factors that require unique solutions.

“You have poor solubility, you have poor absorption, you have netting that out into poor bioavailability,” Romanski says. “You have a need for these formulations to now have a variety of different things in there.”

Check back for part two of Romanski’s conversation with PharmTech Group. In that segment, Romanski turns his attention to regulatory and quality challenges, including the importance of maintaining stringent current good manufacturing practice standards.

Lonza Capsugel can be located at Booth 8.0S76 at CPHI Frankfurt 2025.

Click here for all of our CPHI Frankfurt coverage.

Transcript

Editor's note: This transcript is a lightly edited rendering of the original audio/video content. It may contain errors, informal language, or omissions as spoken in the original recording.

My name is Frank Romanski. I head the Strategic Growth and Revenue Management group and I'm also the head of the Global Pharma Solutions business at Lonza Capsugel. I have a PhD in chemical engineering with a focus on drug formulation, and I've held a number of different roles in life sciences, spanning from R&D to marketing to production to product management, global strategy, and business management. My passion is taking science and converting it into real, commercial processes and working on different drugs that ultimately benefit patients around the world.

Oral delivery is a really interesting area, and it's probably, arguably, one of the oldest technologies in pharmaceutics. It's one that, compared to the rise of biologics and cell and gene therapy, has been one that probably has not grown nearly as fast in recent years. But that's really starting to change, and I think the rise of the GLP-1s [glucagon-like peptide-1 drugs] and the new blockbusters, if you will, that are coming out, is really drawing a lot of attention towards oral delivery once again.

You have to keep in mind that many of these new modalities and different chemistries are a little bit more challenging to work with. In the case of GLP-1s, small peptides, and live biotherapeutics, they're very challenging to formulate. They have a tendency to have an extremely low absorption, extremely low bioavailability. They tend to be very sensitive to things like water and oxygen, and certainly inside the stomach as well. So you really have to target them to get into the right part of the gastrointestinal tract, and ultimately get the payload to where it needs to go, because you're talking very, very tiny percentages of absorption, and that's very, very important.

Now, what's really driving all of this? It's really about patient compliance. Simple fact, adults don't like [using] needles. Children don't like [using] needles. 84% of biologics are actually parenterally administered, and about 2/3 of people that take pharmaceuticals really, really despise the needles. And in fact, there are very large fractions of the population that will just avoid it entirely.

So this is the market that many of our clients and pharmaceutical companies that we work with are going after. They want to have an alternative to many of the injectable dosage forms that are out there, and this is spurring a whole degree of technology to overcome the challenges of taking these small peptides, for example, that may be very sensitive, and getting them into an oral administrative form that can be delivered to these markets and these patients.

I think it's important to say that a lot of the ‘easy’ drugs are done. The days of taking a small-molecule chemistry and mixing it up with some MCC [microcrystalline cellulose] and creating a tablet through direct compression are largely over. And a lot of these molecules that we were just discussing, some of the GLP-1s, the small peptides, etc., they can be a real formulation challenge. And it all really starts with that formulation challenge. You have poor solubility, you have poor absorption, you have netting that out into poor bioavailability. You have a need for these formulations to now have a variety of different things in there.

One example would be penetration enhancers. You may also have different excipients that are in there to protect it from oxygen, or from specific enzymes. All of this has to be thought about pretty early from the formulation development timeline, and that keeps getting pushed back, it feels like. Now, one of the strategies associated with that is to start with a technology that actually can scale from the clinic all the way through commercialization. And I'll give you an example that we work a lot on. We have a product that we have developed and launched called Enprotect. This is a unique, dual-layer capsule that actually has built-in, enteric protection. And what that means is it will bypass the stomach and go directly to the GI [gastrointestinal] tract where the payload needs to be delivered.

There isn’t anything more complicated to a formulator than taking that formulation and encapsulating inside an Enprotect capsule. And in fact, we have even as small as a size 9 capsule, which is very, very tiny. It's actually used in pre-clinical studies to animals, even as small as rats. And you can use that same technology all the way to human trials and ultimately, to commercialization, using the same technology. So you're not scaling and changing unit operations and worried about different changes to the formulation as you go through it.

And not only that, here at Lonza, we not only do work with products like Enprotect, we can fully customize them. So for example, we work with a number of our clients that have challenges with the standard product. We can fully customize it. We can change some of the polymers that are in there. Certainly things like size and color and print, those are obvious, but I'm talking really about the formulation technology that allows us to get those drug developments to the final clinic.

Finally, we also have a CDMO [contract development and manufacturing organization]. The CDMO is based in Tampa, Fla., and we can go end-to-end, fully commercializing from the clinic all the way to commercial manufacturing of these drug dosage forms. So we're trying to offer our clients a lot of different areas of optionality to improve these formulations, all the way from the excipients and capsule design itself through commercial manufacturing.