CDMO Profile Series: Navigating uncharted waters

Feb. 9, 2023
How Ardena’s ‘build and buy’ strategy helped the CDMO steer itself into the international pharma market

The first lighthouse in recorded history — the Pharos of Alexandria — was the tallest manmade structure of its time, standing 450 feet high for hundreds of years. The Egyptian coast was a particularly dangerous place to sail, so the pharaoh ordered the lighthouse to be built in hopes of helping guide ships into port at night.

Despite these efforts, archeologists have found evidence of countless wrecks postdating the lighthouse — proving that the navigational aid was perhaps only as good as sailors’ ability to steer their ships.

The skill to change course quickly and carefully is essential if you want to survive the seas. Having a strong leader at the helm doesn’t hurt either.

Ardena — a Belgium-based global CDMO — has both.

Fueled by a successful M&A strategy and the vision to establish a fully integrated service platform, Ardena has grown from a regulatory consulting agency with 60 workers to a global CDMO with over 500 employees in just five years.

Claiming a stake in the international pharma market was no easy feat, says Harry Christiaens, Ardena’s chief executive officer. Christiaens has led the acquisition and integration of five companies onto one platform, creating the Ardena brand in 2017.

“Diving into uncharted waters requires focus, especially in a failure-prone industry like pharma,” says Christiaens.

But with steadfast confidence, Ardena has successfully navigated both its own growing business and its customers through the drug development life cycle.

Running a tight ship

Ardena offers an integrated service platform that provides end-to-end solutions to pharma companies and biotechs. “We can really operate as what I would call a one- source partner,” says Christiaens. But this was not always the case.

Headquartered in Ghent, Belgium, Ardena now boasts sites all over Europe and its services range from drug substance to drug product development and manufacturing, with expertise in everything from CMC dossier writing to nanomedicine technology.

But long before it became Ardena, the company had its humble beginnings as a contractor specialized in early phase clinical studies and operating a regulatory and compliance consultancy.

Operating under the name Pharmavize, the company initially was focused on supporting large pharma companies by writing their clinical trial applications or authorizations dossiers.

“Today we still have this expertise. We have a regulatory team of 30 people who still help our customers with this element of drug development,” says Christiaens.

Things took a turn for Pharmavize in 2015, when Christiaens decided to grow the business with the participation of a private equity partner. Both parties worked together to further develop and internationalize the business through a structured ‘buy and build’ strategy. And buying they did.

The first purchase, made in 2016, was Crystallics, a Netherlands-based contract research organization specialized in identification, characterization and selection of drug substances, as well as preformulation and formulation services.

“Crystallics had developed proprietary technologies both in hardware and software, including high throughput X-ray powder diffraction technology and laboratory informatics, data analysis and predictive models that made it an appropriate first investment for us,” Christiaens says.

In 2017, the brand acquired a bioanalytical contract laboratory, Analytical Biochemical Laboratory, strengthening its early phase development testing capabilities. This added bioanalytical services to the company’s arsenal, helping them to better support customers in the clinics, and officially launched the Ardena brand. The new brand was conceived to merge the two specialist capabilities brought by Pharmavize and Crystallics, and to solidify their collaboration before proceeding with more acquisitions.

Ardena kept moving through its buy and build strategy, following the drug development pipeline. In 2018, the company bought Syntagon, a Scandinavian drug substance service company with capabilities to produce drug substance batch sizes up to 100 kg, bringing specialist expertise in GMP chromatographic purification processes as well.

By 2019, the company had reported a yearly revenue of $40 million.

Ardena made its most recent acquisition in 2021, purchasing Idifarma, based in Pamplona, Spain. Idifarma offered a full range of services from formulation to analytical and manufacturing services for highly potent drugs.

“There is so much that can go wrong that we have to stay focused on what we can control,” says Christiaens. “What we do as a CDMO is focus on improving the manufacturing techniques, solving analytical challenges, and the regulatory framework.”

Setting sail

Among Ardena’s plethora of acquisitions, it was the 2018 purchase of the Dutch company ChemConnection, a contract manufacturer for novel active pharmaceutical ingredients (APIs) and nanomedicines, that has become a main growth driver for the company. Ardena’s early days as a regulatory consulting agency have helped the company navigate the unmapped territory of nanotechnology.

“It’s not an easy technology,” says Christiaens. “The control of materials in the nanometer size range requires demanding manufacturing techniques, but also performance analytical techniques. And on top, there is also the regulatory challenge. There are no real and global regulatory guidelines for developing nanomedicines.”

And this rising demand for nanomedicine has inspired Ardena to shift its focus from buying to building. “Growing demand in nanomedicines is pushing us to expand our capabilities in that area. Currently, we are building a new site in the Netherlands because we have outgrown our own capacity,” says Christiaens.

But the goal to build and expand goes beyond nanomedicine. Christiaens’ vision for the brand now includes claiming a stake in more markets, as well as tapping into other therapeutic technologies that have shown similar promise to nanotechnology in the last decade.

“We will continue to work with small molecules, but we’re excited to enter into biologic manufacturing in a new fill and finish plant in Belgium,” says Christiaens. “Our main challenge remains to grow this company.”

The group is investing $40 million in the next two years into its sites in Europe, including an expansion to its Södertälje, Sweden campus to increase its capacity and add a new production line, larger preparative high performance liquid chromatography, and additional large scale synthesis equipment.

Of course, the holy grail is establishing a presence in the largest pharma market in the world — the United States.

“The goal now is to buy or build a plant in the U.S.” says Christiaens.  Even though the company currently has clients in the U.S., Christiaens hopes that in the near future, Ardena can serve these clients locally.

“It’s really our dream to become a true global partner for our customers with a physical presence in the United States, helping to navigate them through every stage of the drug development process, and ultimately helping them bring innovative therapies to patients faster.” 

About the Author

Andrea Corona | Senior Editor

Andrea Corona serves as the Senior Editor of Pharma Manufacturing — a leading source of news and insights for pharma professionals — and is responsible for creation of editorial content, moderating webinars, and co-hosting the "Off script" podcast. Her editorial journey started as an as associate editor at Biocompare, an online platform providing product information, industry news, articles, and other resources to support scientists in their work. Before Biocompare, she was a digital producer at Science Friday, focusing on adapting radio segments for the web and social media management. Andrea earned her bachelor's degree in journalism and biology from the State University of New York, at Purchase College.