A researcher at work in an AustinPx laboratory. (Image courtesy of AustinPx)
Thermo Fisher’s Patheon division has signed an exclusive agreement with AustinPx to install the Texas CDMO’s KinetiSol technology at Patheon’s Bend, Oregon, and Cincinnati sites. AustinPx specializes in bioavailability enhancement for orally delivered small molecules, and the placement plugs into Patheon’s Quadrant 2 platform, which applies AI/ML to formulation prediction. It expands access to KinetiSol-enabled amorphous solid dispersion (ASD) work across development, scale-up, and commercial manufacturing.
Some 40% of commercialized drugs and 70% to 90% of candidates still in development are poorly soluble, according to a 2023 review in the journal Life. Poor solubility drags down bioavailability, blunting therapeutic effect and pushing formulators toward higher doses and the side effects that accompany them.
In the following Q&A, AustinPx CEO Elizabeth Hickman discusses demand for differentiated amorphous dispersion technologies.
Thermo Fisher will be the exclusive third-party CDMO for the KinetiSol Formulator. What led AustinPx to route commercial-scale access through an external CDMO rather than build that capacity in-house, and what does “exclusive” cover in practice?
Elizabeth Hickman
Hickman: We are excited to partner with Thermo Fisher Scientific, one of the industry’s largest CMOs, to expand access to AustinPx’s KinetiSol technology. This agreement is a strong indicator of the growing demand for differentiated amorphous dispersion technologies and the need for more tools that solve increasingly complex bioavailability challenges.
While Thermo is our exclusive third-party CDMO for offering early-phase KinetiSol development on the Formulator scale, AustinPx will continue to offer the same KinetiSol capabilities, including Formulator services, we have offered to more than 80 clients over the last four years. We remain the inventor, technology owner, and process experts for KinetiSol, with 16+ years of KinetiSol formulation and process development, scale-up, and technology transfer expertise.
KinetiSol was built for scale, and AustinPx has already supported technology transfers, commercial-scale equipment installations, and registration-scale manufacturing programs. As more client programs move toward Phase 3 and commercial planning, sponsors need confidence that the process knowledge, equipment parameters, and downstream manufacturing requirements can be transferred to a reliable and experienced commercial CMO network.
In the late phase, our goal is to give sponsors commercial optionality and confidence as KinetiSol-enabled programs advance to commercialization. Thermo Fisher adds another access point within that broader KinetiSol commercial ecosystem.
Sponsors can now consider multiple providers for KinetiSol-enabled products, including our commercial partner Microsize and now Thermo Fisher Scientific through this new agreement. The broader value is increased capacity, CMO optionality, and commercial confidence for sponsors looking to develop and commercialize their KinetiSol-enabled products.
What does this agreement unlock for a client that AustinPx could not offer on its own six months ago?
Hickman: The agreement primarily unlocks greater confidence in the downstream path for KinetiSol-enabled products. Clients can approach KinetiSol as a scalable, commercially relevant pathway for challenging molecules from the start, instead of a specialized, last-resort option considered only after other ASD approaches are exhausted. The pharmaceutical industry is slow moving and heavily regulated, so sponsors are understandably cautious about building programs around enabling technologies unless they see a credible path from development into late-stage and commercial manufacturing.
AustinPx was already supporting sponsors through formulation development, scale-up planning, commercial readiness, and technology transfer. We have supported multiple KinetiSol tech transfers, commercial-scale equipment installations, and registration-scale manufacturing programs, helping sponsors translate KinetiSol process knowledge into practical plans for late-stage clinical supply and commercial readiness.
The Thermo Fisher agreement adds another defined route as programs advance, reinforcing the confidence sponsors need to evaluate KinetiSol earlier in development.
KinetiSol sits alongside hot-melt extrusion and spray drying as an ASD route. For a formulation scientist weighing all three, which specific API characteristics point clearly to KinetiSol over the other two?
Hickman: One size does not fit all in ASD development. The decision tree starts with the molecule, but it should also consider the product strategy. The right technology is the one that gives the program the strongest path to performance, scale-up, manufacturability, sustainability, and long-term value.
Spray drying and hot-melt extrusion both have a place, but each comes with constraints. Spray drying depends on the API and polymer system being soluble in a common, pharmaceutically acceptable volatile solvent. Hot-melt extrusion depends on the API and excipient system tolerating sustained thermal exposure, as well as the polymers having the right melt and rheological behavior.
KinetiSol becomes especially relevant when a molecule does not fit neatly inside those boundaries. The clearest technical signals are poor solubility in organic solvents, high melting point, time-dependent thermal lability, heat sensitivity, or a need for polymers and excipients that are not compatible with spray drying or HME. It is also a strong fit when the formulation requires a more complex, multi-component ASD system rather than a simple drug-polymer approach, pill-burden reduction, manufacturability improvements for cost reduction, environmental improvements, or modified or targeted release.
That is why we want sponsors to evaluate KinetiSol early. For the right molecule, KinetiSol can create a lower-risk, higher-value path by improving the odds of technical success, reducing scale-up and commercial manufacturing risk, supporting greener manufacturing, improving patient experience through better dosage forms, strengthening drug product IP, and creating a more differentiated product.
The placement integrates with Patheon’s Quadrant 2 predictive platform. How does KinetiSol process and formulation data feed that AI/ML modeling, and does a larger KinetiSol dataset measurably improve the platform’s predictions over time?
Hickman: Predictive formulation tools are increasingly used in the earliest phases of development, when API and development data is limited. As KinetiSol is incorporated into broader predictive formulation workflows, such as Patheon’s Quadrant 2, sponsors can make better decisions, earlier, about the best formulation path forward for their molecule.
For me, the value is in turning that growing body of KinetiSol data into better development decisions. A larger dataset should make predictive tools more useful over time by helping teams start in a more informed place, conserve limited API, avoid low-value experiments, and identify risks earlier. It does not replace formulation science, but it can make the path from prediction to prototype more efficient. The result is faster learning, lower development risk, and greater confidence that the selected formulation strategy can support performance, manufacturability, and scale-up.
You note sponsors are being encouraged to evaluate KinetiSol earlier. What has historically made them wait, and does having Thermo Fisher in the chain change that calculus?
Hickman: Historically, many sponsors started with the ASD technologies they knew best: spray drying and hot-melt extrusion. Those technologies have been widely used, so they were often the default starting point. As a result, KinetiSol was sometimes considered later, after a molecule encountered solvent, thermal, formulation, pill-burden, or scale-up limitations.
That is changing. KinetiSol is increasingly becoming a first-choice technology for sponsors working with challenging molecules because it brings together performance, scalability, sustainability, and a broader formulation design space. Evaluating KinetiSol earlier can help avoid unnecessary rework, reduce development and scale-up risk, and create a stronger path to long-term product value.
The Thermo Fisher Scientific agreement strengthens that momentum. It gives sponsors another defined pathway for KinetiSol-enabled products moving toward late-stage clinical testing and commercial manufacturing, while reinforcing the industry’s growing confidence in KinetiSol as a high-performance ASD technology that is scalable and commercially relevant. The molecule still drives the technology choice, and this agreement makes it easier for sponsors to evaluate KinetiSol earlier, when formulation decisions can have the greatest impact.
Filed Under: Drug Discovery and Development
