In a move set to redefine the landscape of pharmaceutical formulation, Texas-based contract development and manufacturing organization (CDMO) AustinPx has entered into a landmark exclusive agreement with Thermo Fisher Scientific’s Patheon division. The partnership will see the integration of AustinPx’s proprietary KinetiSol technology into Patheon’s global manufacturing infrastructure, specifically at its sites in Bend, Oregon, and Cincinnati, Ohio.
This collaboration represents a significant leap forward for the industry, which continues to struggle with the persistent challenge of drug solubility. By embedding KinetiSol—a high-performance amorphous solid dispersion (ASD) technology—into Patheon’s Quadrant 2 predictive platform, the partners are aiming to standardize a more efficient, AI-driven pathway for bringing complex, poorly soluble drugs to market.
The Core Challenge: A Crisis of Solubility
The pharmaceutical industry is currently facing a silent crisis: a growing majority of drug candidates are inherently difficult to deliver orally due to poor solubility. According to a 2023 review published in the journal Life, approximately 40% of all currently commercialized drugs, and between 70% and 90% of candidates currently in the development pipeline, exhibit poor aqueous solubility.
When a drug molecule is poorly soluble, its bioavailability—the rate and extent to which the active ingredient is absorbed into the bloodstream—is significantly compromised. To compensate, developers often resort to higher dosing, which frequently leads to increased side effects, reduced patient adherence, and higher manufacturing costs. For decades, the industry has relied on spray drying and hot-melt extrusion (HME) as the primary tools for addressing these issues. However, these legacy technologies often hit physical and chemical limits, leaving many molecules stranded in the pipeline.
Chronology: From Innovation to Industrial Integration
The journey of KinetiSol from a specialized innovation to an industry-standard tool has been one of calculated growth and technical validation.
- 16+ Years of Development: AustinPx has spent over a decade and a half refining the KinetiSol process, building a deep reservoir of expertise in formulation, scale-up, and technology transfer.
- The Early Years (2020–2024): Over the last four years alone, AustinPx has successfully utilized KinetiSol to support more than 80 client programs, proving the technology’s versatility across diverse molecule types.
- The Shift to Scale: Recognizing that "proof-of-concept" is insufficient for commercial success, AustinPx shifted its focus to industrial-scale implementation, supporting registration-scale manufacturing and tech transfers.
- July 2026: The formal announcement of the partnership with Thermo Fisher Scientific marks the transition of KinetiSol from a niche, boutique solution to a globally accessible manufacturing option within one of the world’s largest CDMO networks.
Technical Superiority: Why KinetiSol?
For formulation scientists, the decision to choose one ASD technology over another is often a high-stakes gamble. KinetiSol differentiates itself by offering a wider operational window than traditional methods.
When to Choose KinetiSol
Elizabeth Hickman, CEO of AustinPx, emphasizes that KinetiSol is not intended to replace spray drying or HME, but rather to excel where they fail. "One size does not fit all in ASD development," Hickman notes. KinetiSol becomes the superior choice under several specific conditions:
- Thermal Lability: Molecules that are heat-sensitive or cannot tolerate the sustained thermal exposure required by HME.
- Solubility Constraints: APIs that are poorly soluble in the organic solvents required for traditional spray drying.
- Complex Formulations: Scenarios requiring multi-component ASD systems that cannot be processed via conventional methods.
- Sustainability and Efficiency: KinetiSol is inherently more environmentally friendly, often requiring fewer processing steps and lower energy expenditure, aligning with the industry’s push toward "Green Chemistry."
By providing a viable alternative to the "standard" approaches, KinetiSol allows developers to salvage promising molecules that would have previously been abandoned due to formulation hurdles.
Official Perspectives: CEO Elizabeth Hickman on the Strategic Pivot
In a recent interview, Elizabeth Hickman addressed the rationale behind outsourcing commercial-scale access to an external CDMO, clarifying the nature of the "exclusivity" in this arrangement.
"We remain the inventor, technology owner, and process experts for KinetiSol," Hickman explained. "While Thermo Fisher serves as our exclusive third-party CDMO for offering early-phase KinetiSol development on the Formulator scale, AustinPx continues to offer our own comprehensive suite of services. This partnership is about expanding the ecosystem, not narrowing it."
Hickman stressed that the primary driver for this collaboration was the "confidence gap." For pharmaceutical sponsors, the path from clinical trials to commercialization is fraught with regulatory and technical risks. By creating a standardized, repeatable process that can be transferred seamlessly into the Thermo Fisher global network, AustinPx is de-risking the commercialization phase.
"The agreement unlocks greater confidence in the downstream path," Hickman said. "Clients can now approach KinetiSol as a scalable, commercially relevant pathway from the very start, rather than viewing it as a ‘last-resort’ technology to be used when other methods fail."
Integrating Artificial Intelligence: The Quadrant 2 Advantage
Perhaps the most forward-looking aspect of this agreement is the integration of KinetiSol with Thermo Fisher’s "Quadrant 2" platform. Quadrant 2 leverages AI and machine learning to predict how molecules will perform in various formulation settings.
As KinetiSol data is fed into this predictive model, the accuracy of the platform is expected to increase exponentially. "A larger dataset makes predictive tools more useful over time," says Hickman. "It allows teams to avoid low-value, repetitive experiments and helps them start in a more informed place." This shift toward data-driven formulation is expected to significantly reduce the time and capital required to reach the clinic.
Implications for the Pharmaceutical Industry
The implications of this partnership extend far beyond the two companies involved.
1. The End of "Last-Resort" Formulation
Historically, companies have favored the "known" over the "optimal." By embedding KinetiSol within a Tier-1 CDMO like Thermo Fisher, the technology achieves a level of institutional legitimacy that will encourage pharmaceutical sponsors to consider it during the earliest stages of drug design.
2. CMO Optionality and Risk Mitigation
For global pharma companies, having access to multiple, validated providers is essential for supply chain security. With AustinPx, Microsize, and now Thermo Fisher in the KinetiSol network, sponsors have the flexibility to choose the partner that best fits their specific geographic and logistical needs, without sacrificing the technical integrity of their formulation.
3. Accelerated Development Timelines
By reducing the frequency of "rework"—the process of reformulating a drug when initial approaches fail at scale—this partnership could potentially shave months or even years off the drug development lifecycle. In an industry where a day of patent protection is worth millions, this efficiency is a major competitive advantage.
4. A Greener Future
The emphasis on sustainability is not merely a marketing footnote. The reduction of solvent use and the streamlined manufacturing process inherent in KinetiSol contribute to lower carbon footprints for drug product manufacturing. As global regulators continue to pressure the industry to adopt sustainable practices, KinetiSol provides a clear path to compliance without compromising therapeutic efficacy.
Conclusion: A New Standard for Formulation
The alliance between AustinPx and Thermo Fisher Scientific signals a maturation of the bioavailability enhancement sector. By combining deep, specialized process expertise with the massive, AI-supported scale of a global manufacturing giant, the industry is moving closer to a future where drug solubility is no longer the primary barrier to innovation.
As pharmaceutical sponsors begin to adopt KinetiSol earlier in the development lifecycle, the industry is likely to see a shift in the quality and efficacy of oral drug delivery. For patients, this means more effective, better-tolerated, and more consistently manufactured medicines—a testament to the power of bridging the gap between cutting-edge technology and industrial-scale delivery.
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