To provide flexible and innovative solutions for early development challenges commonly faced by biotech and pharmaceutical companies, Thermo Fisher Scientific Inc. is expanding its oral solid dose (OSD) footprint with a $22 million total investment since 2021 in its Cincinnati, Ohio, and Bend sites.
Together, these expansions will enable research and development (R&D), manufacturing and testing of OSD drug formulations – doubling the Bend site’s existing footprint and continuing a multi-year investment plan in Cincinnati – to bolster capabilities across the company’s global contract development and manufacturing organisation (CDMO) and contract research organisation (CRO) network.
“With more than 30 years of expertise in the space, Thermo Fisher’s OSD teams are dedicated to ensuring customers know what lies ahead by providing unparalleled insights into needs that span from navigating the regulatory landscape to overcoming potential formulation challenges,” said Michelle Logan, Vice President and General Manager, Drug Product North America, Thermo Fisher Scientific.
“Expanding our capabilities in North America builds services in OSD formulations to help ensure that our customers can develop and commercialise accessible, life-saving therapies.”
OSD formulations have long been the most prescribed dosage form in the world and, today, make up 84% of all medications on the market due to storage stability and ease of administration.
To meet the increasing demand for small molecule OSD solutions, Cincinnati adds dedicated flexible R&D space, supporting the preclinical early development of OSD formulations through rapid project initiation and the use of next-generation technologies for data-informed decision making, which can solve for drug development challenges and help companies avoid costly trial-and-error cycles.
The Bend expansion is focused on R&D manufacturing and testing, including bench and pilot scale spray drying, hot-melt extrusion and dry granulation.
These additions to the site bolster capabilities at the company’s centre of excellence for early development and advanced drug delivery, including solubility and bioavailability enhancement solutions and digital modelling.
These capabilities address some of the largest challenges for pharma and biotech customers to help accelerate preclinical oral drug product development and reduce timelines to GMP production of clinical trial materials.
The expansions in Cincinnati and Bend build on the company's continued investment in small molecule OSD solutions, including development and manufacturing services in Bourgoin, France; Manatí, Puerto Rico; Toronto, Canada; Whitby, Canada; and continuous manufacturing in Greenville, NC.
The company has led OSD development by supporting over 125 new drug approvals (NDAs) for clients during the last decade (2011–2023), in addition to producing billions of tablets and capsules annually.