More than three years after acquiring the clinical research organization (CRO) PPD, and seven years after expanding into the contract development and manufacturing organization (CDMO) market by purchasing Patheon, Thermo Fisher Scientific has launched a suite of expanded CRO and CDMO services under its own brand.
The company has introduced to market its Accelerator™ Drug Development, which Thermo Fisher is marketing as “360°” CDMO and CRO drug development solutions, following a formal announcement during the recent CPHI Milan 2024 conference in Milan, Italy.
Accelerator is a customizable suite of manufacturing, clinical research, and clinical supply chain services intended to support the development of treatments ranging from small molecule drugs to larger molecule biologics, oligonucleotides, proteins, peptides, mRNAs [messenger RNAs], biologics, cell therapies, and gene therapies. According to Thermo Fisher, Accelerator is designed to support customers at every stage of the development process, from preclinical studies to commercialization.
“Certainly we can leverage and bring together all the important pieces of the drug development journey and deliver truly end-to-end services, if we may call it that way. And that’s the reason we call it 360 degrees,” Anil Kane, PhD, executive director, global head of technical and scientific affairs at Thermo Fisher Scientific, told GEN Edge.
Kane said Accelerator integrates and expands services long offered by both PPD and Patheon. Thermo Fisher acquired PPD for $17.4 billion in 2021, four years after it shelled out $7.2 billion to buy Patheon.
“We wanted to leverage all the expertise from both the teams as one company,” Kane explained. “The obvious advantages would be from the contractual perspective, the confidentiality perspective, and the project management perspective. Leveraging all those benefits within a company is often very challenging when a sponsor—a biotech company or a big pharma company—tries to manage with different partners. Those efficiencies can be built and can be made effective within a single entity.”
Those efficiencies, Kane added, are expected to save significant expense and time for drug developers, while improving their likelihood of generating effective clinical results, thus enhancing their chances of securing regulatory approvals, then reaching the market and ultimately, patients.
Thermo Fisher is in the process of quantifying the projected savings from Accelerator. Kane said Thermo Fisher delivers CRO and CDMO services to more than 80 customers—but could not furnish an example, citing confidentiality reasons.
On a case-by-case basis, customers can be charged transactionally or strategically: “We are open to discussion. Whatever strategy is best suited for both the partners is what Thermo Fisher would proceed with.”
Industry consolidation
The launch of Accelerator comes as consolidation continues to shrink the number of companies offering CRO and CDMO services.
Thermo Fisher ranked second in GEN’s updated A-List of Top 10 CDMOs, behind top-ranked Lonza Group and just ahead of Catalent.
Since October, Lonza has expanded its manufacturing and services footprint by completing its acquisition of the Genentech large-scale biologics manufacturing site in Vacaville, CA, for $1.2 billion from Genentech’s corporate parent Roche; signing a long-term extension of a collaboration with an undisclosed “major global biopharmaceutical partner” for commercial-scale manufacture of antibody-drug conjugates; and expanding its bioconjugation capabilities in Visp, Switzerland, with two multipurpose 1,200L manufacturing suites and manufacturing-related infrastructure for launch and commercial supply. The Visp expansion is expected to create approximately 200 new jobs and become operational in 2028.
Catalent will disappear from GEN’s A-List upon completion of a $16.5 billion acquisition of the company by Novo Holdings, the asset manager of the foundation that controls Novo Nordisk. Novo Holdings has agreed to sell three Catalent fill-finish sites to Novo Nordisk for $11 billion upfront.
Novo Nordisk and its arch-rival in blockbuster drugs for obesity and diabetes, Eli Lilly, are expanding their own manufacturing capabilities to meet growing demand for the glucagon-like peptide 1 (GLP-1) based treatments.
Novo Nordisk in June announced plans for a $4.1 billion second fill-finish plant at its campus in Clayton, NC, adding 1,000 jobs to the company’s nearly 2,500-person workforce in North Carolina. The company has projected it will spend $6.8 billion toward production of its treatments, 74% more than the $3.9 billion spent in 2023.
$16B commitment
Novo Nordisk’s news came about a month after Lilly announced plans to expand its manufacturing site roughly 30 miles northwest of its Indianapolis headquarters in Lebanon, IN, by building a $5.3 billion plant designed to produce API for its GLP-1 drugs Mounjaro® and Zepbound®. Lilly has committed more than $16 billion toward building new manufacturing sites in the United States and Europe, in sites that include North Carolina’s Research Triangle Park and Concord, NC, as well as Limerick, Ireland, and Alzey, Germany.
Thermo Fisher is also expanding its development and manufacturing capabilities by adding to its oral solid dose (OSD) capabilities, having invested a total $22 million since 2021 to grow its sites in Cincinnati, OH, and Bend, OR.
To meet growing demand for small molecule OSD solutions, Thermo Fisher has added to its Cincinnati site dedicated flexible R&D space that supports preclinical early development of OSD formulations through rapid project initiation and the use of next-generation technologies designed to help solve drug development challenges and help companies avoid costly trial-and-error cycles.
“At our site in Cincinnati, certainly we have added some key equipment that would help not only the early development space—we call it non-GMP space—and some equipment for early proof of concept work in the oral solid dose development, but also equipment and adding capacity in the expansion and investment in pilot scale, and late stage and commercial scale equipment,” Kane said. All this facilitates speed, efficiency, and bringing molecules in the small molecule or solid dose area for our clients.”
Center of Excellence
The expansion of the Bend site is focused on R&D manufacturing and testing, including bench and pilot scale spray drying, hot-melt extrusion and dry granulation. According to Thermo Fisher, the additions will bolster capabilities at the company’s center of excellence for early development and advanced drug delivery, including solubility and bioavailability enhancement solutions and digital modeling.
These capabilities will, in turn, address some of the largest challenges faced by pharmas and biotechs as they work to accelerate preclinical oral drug product development and reduce timelines to GMP production of clinical trial materials, the company added.
“We’ve added development labs and capacities at the Bend, Oregon site, expanding our footprint lab space, which would help our partners with the speed that we can support them in bringing that early development advantage, bringing proof of concept because of resources, capability, capacity, and expertise,” Kane said.
In addition to the Bend and Cincinnati sites, Thermo Fisher’s OSD effort offers development and manufacturing services in Bourgoin, France; Manatí, PR; Toronto, ON; and Whitby, ON; as well as a continuous manufacturing site in Greenville, NC. Thermo Fisher says its OSD development effort has supported more than 125 new drug approvals (NDAs) for customers between 2011 and 2023, producing billions of tablets and capsules annually.
As drug development has come increasingly to depend on machine learning and other artificial intelligence technologies, Thermo Fisher has used elements of these in its CRO and CDMO services.
“Starting from early development, we have already leveraged and have offered predictive modeling in early development of services and drug products,” Kane said. “We have utilized machine learning, artificial intelligence in addressing solubility, bioavailability issues, identifying the right technologies, and reducing that trial and error, and bringing those speed advantages in drug development journey.”
Similarly, Kane explained, Thermo Fisher is leveraging AI technologies in clinical services that include patient recruitment and data analytics: “All these are being leveraged in the CDMO part as well as CRO part, offering advantages through Accelerator.”
“Thermo Fisher continues to listen to our clients,” Kane said. “We want to understand where the demands are, and these investments certainly will bring mutual advantages in offering faster services, and bringing those efficiencies to our partners.”
