Today’s drug products are increasingly difficult to develop and can present numerous formulation challenges. A variety of specialized technologies are needed to overcome the complexity these products often present in development. Sponsors look to CDMOs for these highly-specialized capabilities they often don’t have in-house.

Catalent recently acquired Accucaps Industries, a Canadian-based developer and manufacturer of over the counter, or “OTC” softgels, and conventional pharmaceutical softgels. The acquisition expands Catalent’s global OTC and prescription pharmaceutical softgel capabilities and capacity with the addition of a portfolio of OTC and pharmaceutical products supplied to North America, and two modern facilities offering softgel development, manufacturing, and packaging.

Accucaps’ more than 500 employees at its facilities in Windsor and Strathroy, Ontario, will join Catalent’s network of 11 softgel technologies facilities. The Accucaps facilities house blistering, bottling and other packaging capabilities, as well as prescription softgel development and manufacturing expertise.

Elliott Berger, vice president of global marketing and strategy at Catalent provides additional insight into the acquisition and pharma and biopharma trends driving the outsourcing market. —KB

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Contract Pharma: What were the main drivers for acquiring Accucaps?
Elliott Berger: Catalent tries to help its customers get their products into an optimal dose form, and to market, through a variety of technologies. We’re always looking at ways to expand and deepen our lineup of technologies and capabilities to help address all of our customers’ challenges. In addition to our own scientific development, we consider the acquisition of technologies and of companies that fit our strategy.

Historically, we acquired Micron Technologies for particle size engineering, Pharmatek Laboratories for early drug development, and recently, Accucaps to further strengthen our softgel technology position. Accucaps has two modern sites in Ontario that specialize in pharmaceutical Rx and OTC softgel products, including OTC monograph products, and with dossiers that are available to customers to increase their speed to market. They also have an integrated suite of packaging, blistering, and cartoning, allowing us to deliver turnkey solutions to those customers that need it. The acquisition provides extra capacity in North America augmenting our flagship site in St. Petersburg, FL, which is heavily focused on new pharmaceutical product launches.

CP: What are some of the services that Catalent has added with the acquisition?
EB: Capacity was a key element, but we’ve added capabilities as well. Accucaps has deep and broad OTC development and manufacturing expertise, including available dossiers that enable accelerated product launches. The Canadian operations also have integrated primary and secondary packaging services, and can therefore provide the full, ready-to-go product, whereas our St. Petersburg site mostly produces softgels in bulk.

CP: Would you characterize this as a capability move, capacity, or a geographic move?
EB: It was a combination of all three. For example, capacity expansion in North America. We have three softgel facilities in South America, three in Europe, and several facilities in Asia, but we only had one big North American site. We wanted to strengthen our North American operations for pharmaceutical softgels.  Broader access to the Canadian market is another desirable outcome.  

CP: Based on demand, are there any specific areas Catalent is looking to add capabilities or expand?
EB: In general, the pharmaceutical trend we observe is the increasing difficulty pharma has in getting their molecules from the initial discovery stage into viable, patient friendly, successful treatments. More molecules in development are complex to formulate and difficult to deliver. A lot of them have bioavailability issues, stability issues, dose uniformity, and scalability issues. Computer-aided discovery models and other sophisticated discovery techniques rely on discovering compounds that affect a specific target in the body, but at the same time, to produce treatments that show genuine promise can be very difficult when it comes to delivering them into the body in an appropriate form.

We are really focused on obtaining a set of technologies and expertise to help our customers get those molecules through the development process faster, so that they can provide better treatments for patients. These have included technologies and expertise to help overcome some of the solubility and bioavailability challenges presented by many drugs in development.

As part of this strategy, the Pharmatek acquisition added spray drying, a technology we didn’t previously have, and the Accucaps acquisition has further enhanced our lipid-based formulation systems know-how, which provides a proven and robust bioavailability solution.

Additionally, the acquisition of Micron Technologies added another bioavailability solution. Now, our OptiForm Solution Suite includes all of the proven and innovative technologies that are normally used for bioavailability enhancement, including spray drying after the Pharmatek acquisition, as well as micronization, lipid formulation, salt form optimization, hot melt extrusion, and softgel optimization to our portfolio. Our philosophy is to try and make it easier for our customers to have their problems addressed.

With biologics, our acquisition of Redwood Bioscience a couple of years ago, added a next-generation antibody drug conjugate (ADC) technology that has recently made headlines. Oncology products using this technology are getting closer to the clinic. With the older ADC technologies, when attaching toxins, you couldn’t reliably predict how many and where they would attach, so it was more toxic for the patient and more dangerous and difficult to develop. 

Using Catalent’s Hydrazino-Pictet-Spengler (HIPS) chemistry and 4AP linker, preclinical data has shown that this optimization of payload placement and linker composition, combined with the stability afforded by HIPS chemistry, leads to better tolerability and expanded therapeutic index. In other words, this technology attaches just the right amount of toxins, in just the right place, with more stable chemistry resulting in a much safer, ADC with a number of other benefits, including robust manufacturability.

It’s so difficult to get a product to market these days. The attrition rate is particularly high.  We believe no molecule should fail because of a formulation issue. There are enough challenges, and that should not be one of them. 

We have more than 30 sites around the world and we want to make sure we have all that our customers need to overcome current challenges, and not what they needed 20 years ago.

CP: What specialized capabilities will drive the outsourcing market in the next few years?
EB: One trend is difficult molecules that not only require the right technology, but the right expertise using that technology. The interesting thing about Catalent, unlike most other contract development and manufacturing organizations (CDMOs), is that several of the technologies that we have are not in-sourced, but rather out-sourced. A limited number of customers have softgel, hot melt extrusion, spray drying, or micronization expertise and capacity in-house. We have the technologies and expertise to help customers address their most difficult challenges.

The second trend we have noticed is smaller companies taking their innovative drugs further as they have access to more funding. If they don’t get acquired, increasingly, they go further into development.

Where these small companies don’t have the capability to manage multiple vendors, they seek us out. They have different requirements and often specialty manufacturing needs. Such customers require flexibility on the part of the manufacturer to be able to provide different types of approaches to satisfy their needs.

If you go from development, to scale up and manufacturing, you need to make decisions earlier. By the time you seek regulatory approval, you have to have a manufacturing plan in place, and by the time you expect approval, you have to invest in the equipment, which is risky. In the past, a company would perhaps build a facility anticipating a “blockbuster” drug product. Today, there are too many uncertainties, so we try to make sure we have the flexibility and capacity to create the right type of manufacturing solution for our customers. CP

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Elliott Berger is Catalent’s Vice President of Global Marketing and Strategy. He is also a founding board member of the Catalent Applied Drug Delivery Institute, established to further the improvement of patient outcomes through industry and academic collaboration. Prior to joining Catalent in 2010, Elliott was Vice President of Marketing in the Innovation Group at Johnson & Johnson Consumer Companies (J&J), a department responsible for the introduction of new-to-the-world product launches. Prior to this, he was Global Group Product Director for the Baby Business at J&J where he led digital strategy, marketing and media innovation for Johnson’s mega-brand. Earlier in his career, he was Global Director for J&J’s Baby Business leading the emerging markets growth strategy, resulting in significant double-digit growth across Russia, Middle East, India, China and Brazil.