Agreement bolsters KinetiSol’s commercial pathway for growing late-phase client base
GEORGETOWN, Texas--(BUSINESS WIRE)--AustinPx, a contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement for orally delivered small molecule drugs, today announced its agreement with Thermo Fisher Scientific’s Patheon pharma services for the installation of AustinPx’s KinetiSol™ Technology equipment.
Under the agreement, AustinPx will install KinetiSol equipment at Thermo Fisher’s Bend, Oregon, and Cincinnati, Ohio, oral solid drug manufacturing sites, extending KinetiSol capabilities from development and scale-up through commercial manufacturing. As the exclusive third-party CDMO provider offering the KinetiSol Formulator technology, Thermo Fisher will provide customers with an integrated pathway to advance KinetiSol-enabled products across the drug development lifecycle.
KinetiSol is AustinPx’s solvent-free, fusion-based amorphous solid dispersion (ASD) technology designed to enhance the bioavailability of poorly soluble drugs while streamlining scalability and enabling more environmental and economic sustainability. The technology has been proven to open the formulation design space for challenging active pharmaceutical ingredients, including molecules with high melting points, poor organic solvent solubility, and heat sensitivity.
AustinPx continues to see significant interest in and utilization of KinetiSol among sponsors working with poorly soluble drug candidates that require improved bioavailability, manufacturability and sustainability. Since launching AustinPx in 2022, KinetiSol has been used by more than 70 pharmaceutical and biotech companies, including seven of the top ten large pharmas.
“This agreement marks an important milestone for AustinPx, our clients, and the growing number of molecules enabled by KinetiSol Technology,” said Elizabeth Hickman, CEO of AustinPx. “Thermo Fisher’s agreement with KinetiSol provides important external validation from an established global CDMO with deep experience in advanced formulation technologies and commercial manufacturing.”
For AustinPx’s KinetiSol clients, the agreement provides another proven route to late-stage and commercial manufacturing of their KinetiSol-enabled products. It also expands the KinetiSol ecosystem and demonstrates the technology’s commercial relevance for sponsors seeking to evaluate KinetiSol earlier as part of a long-term ASD strategy.
“At Thermo Fisher Scientific, we are committed to helping our customers accelerate the development and delivery of life-changing medicines,” said Jennifer Cannon, President, Commercial, Biopharma Services, Thermo Fisher Scientific. “The addition of KinetiSol Technology strengthens our advanced oral drug delivery capabilities and provides customers with greater flexibility as they move innovative therapies from IND approval to commercialization. This collaboration reflects our shared commitment to enabling solutions for challenging molecules and improving access to critical treatments for patients worldwide.”
To learn more about KinetiSol Technology and AustinPx’s agreement with Thermo Fisher, visit www.AustinPx.com/kinetisol-commercial-paths/.
About AustinPx
AustinPx is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. We specialize in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules - including our next generation amorphous dispersion platform, KinetiSol™ Technology. For more information, visit www.AustinPx.com
Thermo Fisher’s Bend, Oregon site is a Center of Excellence for solubility enhancement and oral drug product development, supporting preclinical and clinical development. The site has deep expertise in spray drying, hot melt extrusion, and size-reduction technologies as well as small-scale conventional tablet and capsule manufacturing capabilities. As the exclusive third- party CDMO site offering the KinetiSol Formulator, this agreement expands Bend’s offering of API-sparing approaches to material characterization, formulation development and manufacturing to support early phase clinical trials and to de-risk scale-up and transfer of processes throughout Thermo Fisher’s commercial network.
Thermo Fisher’s Cincinnati site offers both commercial manufacturing and fully integrated pharmaceutical development services. The Cincinnati site serves as a Center of Excellence for controlled and sustained release of solid oral dosage forms, including liquid-filled hard-shell capsules, osmotic release multi-layer tablets, active coating, hot melt extrusion and pelletization are among the dosage forms and technologies offered at the site. The addition of a KinetiSol Compounder will further broaden the offering of late-phase and commercial manufacturing capabilities at Thermo Fisher’s largest US oral-solid dose manufacturing site.
Contacts
Media Contact:
Abby Ryan
(512)-686-2146
aryan@AustinPx.com
