In a move set to redefine the landscape of pharmaceutical manufacturing, AustinPx, a Texas-based contract development and manufacturing organization (CDMO), has entered into a landmark exclusive agreement with the Patheon division of Thermo Fisher Scientific. This strategic partnership centers on the deployment of AustinPx’s proprietary KinetiSol technology across Thermo Fisher’s facilities in Bend, Oregon, and Cincinnati, Ohio. By integrating this advanced amorphous solid dispersion (ASD) platform into a global manufacturing powerhouse, the companies aim to provide pharmaceutical sponsors with a robust, scalable, and commercially validated pathway for the most challenging, poorly soluble drug candidates.
The Core Challenge: Solving for Solubility
The pharmaceutical industry currently faces a "solubility crisis." Recent data published in the journal Life underscores the severity of the problem: approximately 40% of commercialized drugs and an overwhelming 70% to 90% of candidates currently in the development pipeline suffer from poor aqueous solubility.
When a drug molecule is poorly soluble, its bioavailability—the proportion of the drug that enters the circulation and is able to have an active effect—is significantly compromised. This limitation forces formulators to rely on higher dosing regimens, which inherently increases the risk of adverse side effects and complicates patient compliance. AustinPx’s KinetiSol technology was developed specifically to address these obstacles, utilizing a fusion-based process that eliminates the need for solvents or prolonged thermal exposure, thereby enabling the formulation of molecules previously considered "undruggable."
A Chronology of Collaboration and Technical Evolution
The integration of KinetiSol into the Thermo Fisher ecosystem represents the culmination of years of technical refinement and industry advocacy by AustinPx.
- Foundation (2008–2022): Over the past 16 years, AustinPx has refined the KinetiSol process, moving from initial benchtop feasibility studies to sophisticated technology transfers. During this period, the company supported over 80 distinct client programs, proving the technology’s viability in diverse pharmaceutical applications.
- The Scale-Up Era (2023–2025): Recognizing the need for global commercial capacity, AustinPx focused on establishing a network of partners. By successfully executing technology transfers and commercial-scale equipment installations, the company moved KinetiSol from a "niche" tool to a reliable, industrial-grade process.
- The Strategic Pivot (June 2026): The announcement of the exclusive agreement with Thermo Fisher’s Patheon division marks the transition of KinetiSol into the mainstream. By placing the technology at major hubs in Oregon and Cincinnati, the partnership provides sponsors with an "industrialized" version of the technology that is seamlessly connected to established global supply chains.
Technical Synergy: The Quadrant 2 Integration
One of the most compelling aspects of this agreement is the integration of KinetiSol into Thermo Fisher’s "Quadrant 2" platform. Quadrant 2 is a state-of-the-art predictive formulation tool that leverages artificial intelligence (AI) and machine learning (ML) to forecast the optimal formulation strategy for a new chemical entity.
By feeding KinetiSol-specific process and formulation data into this AI engine, the platform becomes exponentially more accurate. As the dataset grows, the predictive modeling can better identify which molecules are ideal candidates for KinetiSol, reducing the "trial and error" phase that often consumes precious API (Active Pharmaceutical Ingredient) in the early stages of development. This creates a feedback loop: better data leads to better predictions, which leads to more efficient development, ultimately shortening the time-to-market for life-saving therapies.
Official Perspective: Q&A with CEO Elizabeth Hickman
In an exclusive discussion, AustinPx CEO Elizabeth Hickman shed light on the strategic reasoning behind this partnership and what it signals for the future of drug development.
On the Definition of "Exclusivity"
"We are thrilled to partner with Thermo Fisher Scientific," Hickman stated. "While they serve as our exclusive third-party CDMO for offering early-phase KinetiSol development on the Formulator scale, AustinPx remains the primary architect and technology owner. We continue to offer our own KinetiSol services, as we have for over a decade. The partnership is about expanding the ‘commercial ecosystem.’ We want our sponsors to have options, whether they choose to work with us, our partner Microsize, or now, the global scale of Thermo Fisher."
On Shifting the "Last-Resort" Paradigm
"Historically, sponsors viewed KinetiSol as a ‘Plan B’—a last-resort option after spray drying or hot-melt extrusion had failed," Hickman explained. "Our goal with this agreement is to change that calculus. When a client knows that a robust, validated commercial route exists at a global CDMO like Thermo Fisher, they can afford to evaluate KinetiSol at the start of their program. It eliminates the fear of being ‘stuck’ with a proprietary technology that lacks a path to large-scale manufacturing."
On the Technical Decision Tree
When asked how formulators should choose between spray drying, hot-melt extrusion (HME), and KinetiSol, Hickman emphasized that one size does not fit all. "Spray drying requires the API to be soluble in common organic solvents, while HME requires the API to survive thermal stress. KinetiSol thrives where these two reach their limits. If a molecule has a high melting point, is heat-sensitive, or requires complex multi-component systems, KinetiSol is often the superior, lower-risk choice."
Implications for the Pharmaceutical Industry
The implications of this partnership extend far beyond the two companies involved.
1. Risk Mitigation for Biotech Sponsors
For smaller biotech firms, the primary barrier to adopting innovative formulation technology is the risk of "vendor lock-in." By formalizing an agreement with an industry giant like Thermo Fisher, AustinPx has effectively de-risked KinetiSol. Sponsors can now confidently build their clinical development programs around KinetiSol, knowing that the manufacturing infrastructure is available on a global scale.
2. Enhancing Sustainability in Manufacturing
KinetiSol is inherently more sustainable than many traditional methods. Because it is a solvent-free process, it eliminates the environmental costs associated with solvent recovery, storage, and disposal. As the pharmaceutical industry faces increasing pressure to adopt "green chemistry" practices, the adoption of KinetiSol is expected to accelerate as a way to meet corporate ESG (Environmental, Social, and Governance) targets.
3. Patient-Centric Innovation
Ultimately, the goal of this collaboration is to improve patient outcomes. By enabling the development of orally delivered drugs that would otherwise be injectable or impossible to formulate, KinetiSol improves the patient experience. Fewer injections, lower pill burdens, and improved drug efficacy represent a significant step forward in personalized medicine.
Future Outlook
As the pharmaceutical pipeline continues to favor complex, low-solubility small molecules, the need for enabling technologies like KinetiSol will only grow. With the integration of AI-driven predictive modeling and the backing of global manufacturing leaders, the partnership between AustinPx and Thermo Fisher represents a pivotal shift.
The industry is moving away from a "default" approach to formulation—where sponsors rely on the same outdated tools for decades—and toward a model where technology choice is driven by data, scalability, and patient outcomes. As KinetiSol becomes an increasingly standard tool in the formulator’s toolkit, the collaborative efforts of AustinPx and Thermo Fisher will likely be remembered as the moment when the "solubility gap" finally began to close.
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