Thermo Fisher Expands Drug Development and Manufacturing Offerings at CPHI Milan 2026
Key Points
- Thermo Fisher's expanded CPHI Milan 2026 portfolio spans oral solid dose, sterile drug product, clinical supply, and digital capabilities under its Accelerator Drug Development model, aimed at reducing handoffs between service providers.
- New investments include KinetiSol Technology through AustinPx for poorly soluble compounds, Gerteis dry granulation in France and Canada, expanded sterile capacity in Massachusetts and Italy, and a 52,000-square-foot clinical labeling expansion in Bohemia, New York.
- Through its PPD clinical research business, generative AI has delivered a reported 50% aggregate reduction in master informed-consent drafting time, with 15–30% reductions in certain site-enrollment and activation activities.
Thermo Fisher Scientific is using CPHI Milan 2026 to highlight a broader set of drug development, manufacturing, clinical supply, and digital capabilities aimed at helping pharmaceutical and biotechnology companies move programs from early development toward commercialization with fewer operational handoffs.
The company’s expanded portfolio includes new approaches for oral solid dose and sterile drug product development, additional manufacturing capacity, technologies for poorly soluble compounds, and digital tools designed to improve the execution of clinical studies.
Among the offerings being highlighted is OSD Express, a defined development solution for oral solid dose programs. The approach is intended to give sponsors a more structured path through development while improving predictability and reducing complexity as programs progress.
The offering forms part of Thermo Fisher’s broader Accelerator Drug Development model, which links services spanning drug development, clinical trials, endpoint solutions, clinical supply, and laboratory operations. By connecting these capabilities, the company aims to reduce transitions between service providers and maintain continuity as programs move through development milestones.
Thermo Fisher is also broadening its small-molecule development capabilities through its collaboration with AustinPx. The relationship provides access to KinetiSol Technology, a solvent-free process intended to improve the bioavailability of poorly soluble drug candidates and support their progression from development through commercial manufacturing.
Additional investments are being made in oral solid dose manufacturing. Thermo Fisher is adding Gerteis technology for advanced dry granulation and tablet manufacturing at sites in Bourgoin, France, and Whitby, Canada. The company is also expanding serialized packaging capabilities in Cincinnati and Toronto.
Thermo Fisher is introducing Steriles Express Solutions, a defined framework covering both early sterile drug product development and later-stage technology transfer. According to the company, Steriles Express Early Development is designed to deliver Phase I or Phase II clinical trial material in as little as 20 weeks. Steriles Express Tech Transfer is designed to support production of a Phase III GMP batch in as little as 26 weeks.
The company is simultaneously increasing sterile drug product capacity. Investments at facilities in Plainville, Massachusetts, and Monza and Ferentino, Italy, are expanding capabilities for development and commercial manufacturing of vials and prefilled syringes.
In Ridgefield, New Jersey, Thermo Fisher is also expanding fill-finish and drug-device capabilities. The site is part of the company’s broader work in combination products, including its previously announced collaboration with SHL Medical.
“Drug development increasingly depends on decisions and capabilities that span traditional boundaries, from development and manufacturing to clinical supply and clinical execution,” says Mike Shafer, Executive Vice President and President of Biopharma Services at Thermo Fisher Scientific. The company’s investments, he said, are intended to connect capabilities as well as increase capacity, giving sponsors greater continuity as programs move through development and toward commercialization.
Thermo Fisher’s expansion at CPHI Milan extends beyond small-molecule and sterile drug products. At its Plainville, Massachusetts, operations, new bioprocessing equipment is expected to increase US-based cGMP manufacturing capacity for monoclonal antibodies. The company has also opened a U.S. Bioprocess Design Center intended to help customers translate process-development innovations into scalable manufacturing approaches.
The company is further expanding its Gibco cell culture media portfolio with CHO-K1 Catalog Panel Media and Feed. The cGMP-ready products are designed to support cell growth and protein production in biologics manufacturing workflows. Clinical supply operations are also receiving additional investment. A 52,000-square-foot expansion in Bohemia, New York, will increase clinical labeling capacity, while a new facility in Heiwajima, Tokyo, is expected to approximately double Thermo Fisher’s storage, distribution, and secondary packaging capacity in Japan. The Tokyo facility will support materials ranging from controlled ambient conditions to ultra-low-temperature storage.
Thermo Fisher is also deploying scalable technologies across its clinical supply network for drug-device combination product assembly, labeling, and packaging. The company says the technologies are intended to support different stages of development, allowing automation to increase as clinical programs progress and volumes become more substantial.
Digital technologies are another focus of Thermo Fisher’s CPHI Milan presentation, with the company highlighting applications of artificial intelligence and data analytics in clinical development. Through its PPD clinical research business, Thermo Fisher has been applying generative AI to selected clinical-development activities. One application has resulted in a reported 50% aggregate reduction in the time required to draft master informed consent forms. The company also reported reductions of approximately 15% to 30% in certain clinical research associate activities associated with site enrollment and activation in some studies.
Separately, Thermo Fisher is expanding its real-world evidence capabilities through the PPD CorEvitas Vitiligo Registry. The registry is designed to collect longitudinal evidence relating to treatment effectiveness, disease burden, and patient outcomes. The company’s digital clinical solutions portfolio also includes Clario’s eCOA Swift, which captures electronic clinical outcome assessment data directly from patients. The platform is being used in early-stage oncology studies to provide sponsors with additional insight into tolerability and the patient experience as drug programs progress.
Taken together, the investments reflect a broader shift among contract development and manufacturing organizations toward integrated development models that combine laboratory, manufacturing, clinical supply, clinical research, and digital capabilities. For sponsors managing increasingly complex development programs, the ability to move between these functions without repeated technology transfers or changes in service providers can become an important consideration as candidates approach later-stage trials and commercialization. Thermo Fisher’s CPHI Milan offerings are designed around that premise, combining expanded physical capacity with standardized development pathways and digital technologies intended to improve execution across the drug development lifecycle.
For more information, visit www.thermofisher.com.
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