In a move set to reshape the landscape of oral drug delivery, AustinPx—a Texas-based contract development and manufacturing organization (CDMO)—has entered into an exclusive agreement with the Patheon division of Thermo Fisher Scientific. This strategic partnership centers on the integration of AustinPx’s proprietary KinetiSol technology into Thermo Fisher’s global manufacturing infrastructure, specifically at its sites in Bend, Oregon, and Cincinnati, Ohio.
By embedding KinetiSol within Thermo Fisher’s established "Quadrant 2" platform, the collaboration promises to provide pharmaceutical sponsors with a seamless, scalable, and AI-driven pathway to overcome the persistent challenge of drug solubility.
The Challenge: The Solubility Crisis in Drug Development
The pharmaceutical industry is currently grappling with a significant formulation hurdle. According to a 2023 review published in the journal Life, approximately 40% of all commercialized drugs and an overwhelming 70% to 90% of candidates currently in the development pipeline suffer from poor aqueous solubility.
This lack of solubility serves as a "bottleneck" in drug development, directly impeding bioavailability. When a drug is poorly absorbed, the therapeutic effect is blunted, often forcing clinicians to prescribe higher doses. These elevated dosage requirements not only increase the risk of adverse side effects for the patient but also escalate manufacturing costs and complexity. For the industry, solving the solubility puzzle is not merely a technical preference; it is a critical requirement for bringing next-generation therapeutics to market safely and efficiently.
A Chronology of Collaboration and Technical Integration
The partnership between AustinPx and Thermo Fisher represents the culmination of years of industry-led demand for more flexible, robust amorphous solid dispersion (ASD) technologies.
- Foundation: Over the past 16 years, AustinPx has refined its KinetiSol process, building a robust intellectual property portfolio and a track record of supporting over 80 client programs.
- The Strategic Shift: Recognizing that pharmaceutical sponsors require a clear, risk-mitigated pathway from early-stage development to commercial-scale manufacturing, AustinPx sought to broaden its reach. Rather than building all commercial-scale capacity in-house, the company opted for a strategic collaboration with a global leader.
- Integration: The agreement, announced in mid-2026, involves the installation of KinetiSol manufacturing equipment at Thermo Fisher’s Patheon sites. This infrastructure is being integrated with Patheon’s Quadrant 2 platform, an AI/ML-driven predictive tool designed to optimize formulation strategies.
- Future Outlook: With this agreement, sponsors can now utilize KinetiSol from the initial prototype phase through to large-scale commercial production, with the added security of a world-class CDMO network.
Unlocking New Possibilities: The KinetiSol Advantage
KinetiSol stands as a distinct alternative to traditional ASD methods like spray drying and hot-melt extrusion (HME). While these incumbent technologies remain industry staples, they are subject to specific physical constraints. Spray drying, for instance, requires an API and polymer system to be soluble in common volatile organic solvents. HME, conversely, demands that the materials can withstand significant thermal exposure without degrading.
KinetiSol bypasses these limitations by utilizing a high-energy, solvent-free fusion process. As AustinPx CEO Elizabeth Hickman explains, the technology is uniquely suited for "difficult" molecules:
"KinetiSol becomes especially relevant when a molecule does not fit neatly inside the boundaries of traditional methods. The clearest technical signals for KinetiSol include poor solubility in organic solvents, high melting points, thermal lability, or heat sensitivity."
By removing the reliance on solvents and extreme heat, KinetiSol allows for the use of a wider variety of excipients, enabling the creation of complex, multi-component amorphous dispersions that were previously considered impossible to manufacture.
Official Perspectives: CEO Elizabeth Hickman on Strategic Optionality
In a recent Q&A, AustinPx CEO Elizabeth Hickman highlighted that the agreement with Thermo Fisher is more than just a capacity expansion—it is a confidence-building mechanism for the entire industry.
"Historically, many sponsors started with the ASD technologies they knew best: spray drying and hot-melt extrusion," Hickman noted. "As a result, KinetiSol was sometimes considered only as a ‘last-resort’ option after a molecule encountered solvent, thermal, or scale-up limitations. This agreement changes that calculus."
Hickman emphasizes that by providing a "defined route" into the late-stage commercial manufacturing ecosystem of a giant like Thermo Fisher, sponsors can now evaluate KinetiSol as a "first-choice" technology.
"Our goal is to give sponsors commercial optionality," Hickman added. "The pharmaceutical industry is inherently risk-averse and heavily regulated. By providing a credible path from early development to commercial-scale, we are reducing the friction that often prevents companies from adopting innovative, high-performance technologies early in the lifecycle of their drug."
Implications for the Industry: AI, Data, and Efficiency
One of the most compelling aspects of this partnership is the integration of KinetiSol with Thermo Fisher’s Quadrant 2 platform. This predictive engine uses machine learning to simulate how different formulation strategies will behave before a single milligram of API is used in the lab.
Data-Driven Decision Making
By feeding KinetiSol process and formulation data into the Quadrant 2 engine, the platform becomes exponentially more accurate. As the dataset grows, the AI can better predict which molecules will respond optimally to KinetiSol, helping sponsors avoid "low-value" experiments.
Sustainability and Manufacturing Efficiency
Beyond mere solubility, the shift toward KinetiSol supports the broader industry goal of "green chemistry." Because the process is solvent-free, it reduces the environmental footprint of manufacturing and eliminates the need for expensive solvent recovery systems.
Strengthening the Pipeline
For the clinical stage, the ability to move from bench to commercial scale without changing the fundamental manufacturing technology is a massive advantage. "It creates a lower-risk, higher-value path," says Hickman. "It improves the odds of technical success, reduces scale-up risk, and creates a more differentiated product that can better serve the patient."
Conclusion: A New Standard for Oral Delivery
The collaboration between AustinPx and Thermo Fisher Scientific marks a turning point in how the industry approaches the "poorly soluble" drug problem. By combining the agility and technical expertise of a boutique CDMO with the massive scale and data-driven capabilities of a global leader, the partnership creates a robust, reliable, and accessible framework for pharmaceutical innovation.
As the industry moves further into an era of complex, specialized therapeutics, the ability to navigate formulation challenges with speed and confidence will be a primary competitive advantage. For sponsors, the "exclusive" nature of this agreement is not about limiting options; it is about providing a high-confidence, standardized highway for KinetiSol-enabled products to reach the patients who need them most.
With KinetiSol now firmly established within the Patheon network, the barrier to entry for utilizing advanced ASD technology has effectively been lowered, signaling a shift toward more efficient, effective, and sustainable drug development. The era of seeing solubility as a "dead-end" for a promising molecule is rapidly coming to an end.
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