Navigating the global pharmaceutical landscape with facilities across five continents.
By 2021, the drug delivery market is forecasted to reach approximately $1,700 billion—rising from $1,200 billion in 2016—one report by Markets and Markets projects. An increase in demand for biologics, drug delivery technology, and the prominence of chronic diseases are expected to drive this movement forward in the coming years.
With such a fertile ground for opportunity, many contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs) have immersed themselves in drug delivery technologies along with traditional drug and biologic development and manufacturing. Headquartered in Somerset, New Jersey, CDMO Catalent Pharma Solutions is no exception.
Currently employing more than 9,500 people—including more than 1,400 scientists across more than 30 facilities and five continents—Catalent serves 41 of the top 50 biotechnology companies and 48 of the top 50 pharmaceutical companies. The company manufactures oral, sterile, and inhaled dose forms, produces biologics for preclinical, clinical and commercial supply, and provides clinical and primary packaging for many of the doses it manufactures, as well as custom glass-free vials that can accommodate biotechnology, and stick packs for powders, liquids and gels .
“We are organized into three business units,” Alessandro Maselli, Senior Vice President of Global Operations, explained. Those three business units include softgel technologies, drug delivery solutions, and clinical supply solutions.
The softgel business of today, Maselli said, is “Catalent’s oldest legacy business, with its roots stretching back over 80 years to RP Scherer softgel.”
Originating from a collection of organizations that provided development and manufacturing of various dosage forms and services, the company was “put together under Cardinal Health to serve the pharmaceutical industry broadly,” said Elliott Berger, Vice President of Global Marketing & Strategy.
“Catalent is the largest development and supply partner to the industry,” Berger continued. “In terms of the dosage form and the development of those dosage forms, we are the number one partner for the industry. We specialize across consumer health, prescription, and oral, inhaled, biologic, and sterile dosage forms.”
However, Catalent Pharma Solutions only came into being in its current form 10 years ago.
“Since then we’ve been shaping the organization into an integrated global provider that partners with most of the consumer health, biologics, and big pharma companies, as well as the smaller companies around the world,” said Berger, adding that (as of July 2014) Catalent is now a public company.
Capabilities & Facilities
Catalent operates on a global scale. With more than 30 facilities across five continents, the company reviews best practices holistically.
“We see so much in terms of R&D, regulatory, and executional work across the network, that we spend a lot of time trying to make sure best practices are shared and implemented for the benefit of customers and patients everywhere,” said Berger.
With more and more customers launching their products globally, the company has had to adapt.
“At any time, some of our sites may be supplying the same products to 20 or 30 or 40 markets for the same customer. There’s a lot of global integration of best practices and global customer services,” said Berger, adding that the company’s sites are registered by 35 of the top regulatory agencies around the world.
“The market is moving toward a single global regulatory framework,” Maselli said. “Distributing products in so many different markets creates the conditions where our facilities get affected by multiple regulatory bodies. . . . We need to be inspection-ready all of the time.”
In addition, Catalent works with customers in order to provide guidance for working in the various global marketplaces.
“As we develop products with customers and we know where it is they’d like to go, we can help them prepare for regulatory filings and for other requirements of those markets—for example, by making sure they have the proper Chemistry, Manufacturing and Controls (CMC) materials and other supporting work done. Then we’ll support them through the launches in whichever markets they are working in,” said Berger.
Finding the Global Sweet Spot
With new trends constantly impacting the market—providing shifts and fluctuations—CMOs and CDMOs have to be on their toes, ready to meet new market demands.
“For our business, we go where our customers are,” said Berger. “The majority of R&D for medicines happens in the U.S. and Europe, and [therefore] we have a leading presence in these markets—matching the customers’ needs.”
Catalent also has a presence in Brazil, Argentina, Japan, China, and Australia for its softgel, drug delivery solutions, clinical supply, and consumer health businesses.
“The Asia-Pacific region is probably the fastest-growing region in terms of consumer health, where a lot of the population can now afford to get into the health and wellness area as a trend,” said Berger. “But I would say, looking forward, more countries are beginning to get into novel medicine development. And I wouldn’t be surprised if in about 10 years South Korea, China, and possibly Russia are working on more novel medicines where Catalent technologies and expertise would be of benefit.”
Acquiring Desired Technologies
“The trend of the market is toward patient centric developments of more complex formulations, which together require more sophisticated technologies for delivering the molecules in the body,” said Maselli.
Berger added that the company’s strategy has “always been to try to help customers get the more challenging molecules to market with better enabling technologies at an accelerated rate.”
And, prior to the two strategic acquisitions it made since 2014, the company didn’t yet have the expertise of two technologies in their portfolio: micronization and particle-size engineering.
Micronization and spray drying, according to Maselli, are two technologies Catalent utilizes to facilitate better bioavailability of certain molecules.
Catalent acquired Micron Technologies (a global provider of particle-size engineering technologies) and Pharmatek Laboratories (a West Coast, U.S.-based specialist in spraying drying technologies, drug development, and clinical manufacturing), allowing the company to partner with more pharmaceutical innovators at earlier stages of the drug development process.
“We’ve acquired and integrated them so we could offer that capability alongside our other technologies in bioavailability, stability, and manufacturing of molecules in an integrated fashion that can be done faster and more efficiently than through multiple suppliers (both on a clinical scale and the commercial stage),” said Berger.
Recently Catalent has also acquired Pharmatek in San Diego, California to further enhance its expertise in early phase drug development, formulation and clinical manufacturing.
What makes Catalent unique? The company’s technologies, according to Berger.
“From softgels to hot melt extrusions to injectables to cell engineering, we have a number of technologies that we can bring to bear to help our customers progress their development programs—not only taking whatever it is they’ve developed in-house and trying to manufacture it at commercial scale,” he said.
Furthermore, having been in the softgel business for more than 80 years, the company has worked with thousands of molecules across the world in all therapeutic areas.
“We make approximately 70 billion doses each year,” said Berger. “By rough calculation, that’s one in 20 branded Rx and OTC products that consumers take around the world.
“For me, what makes this [work] fulfilling is that exact thing—we help to make these products (these important medicines or vitamins) better and we help to overcome challenges that might have prevented them from getting to the market. And we help to get them to the market faster.
“These products—from life-saving cancer treatments to vitamins—are getting to the people that need them and want them, and they are of a high quality in customer-preferred dose forms.”
Despite having years of experience, there will always be a number of challenges each company in the pharmaceutical industry must face.
“The biggest challenge nowadays is that molecules are more sophisticated and there’s more regulation and more scrutiny (and everything is more global),” said Berger. “Working through these challenges with our customers and getting products to patients—that’s what matters most to me.”