Articles
Precision Without a Playbook: How Agile CDMOs Enable Personalised Drug Development
In this article, Elizabeth Hickman (CEO, AustinPx) and Dave Miller (CSO, AustinPx) discuss how as precision medicine becomes the new standard, traditional development models are falling short. This article highlights the challenges of formulating and manufacturing personalised therapies, from poor solubility and stability issues to the growing need for patient-friendly dosage forms. Agile CDMOs are stepping up to fill the gap, offering the flexibility, scientific depth and creative problem-solving needed to navigate these complex therapeutic spaces.
Sustainability in Pharma Manufacturing: Strategic Benefits of Going Green
In this piece, AustinPx's CEO, Elizabeth Hickman, explores how sustainability is becoming a strategic priority across the pharmaceutical supply chain. From renewable energy and waste reduction to IoT and blockchain-based transparency, companies are finding that going green is not just good for the planet, it improves supply chain resilience and profitability. Hickman highlights how CDMOs and pharma developers alike can adopt innovative technologies and lean practices to reduce their environmental footprint and gain a competitive edge.
Partnerships To Be Precise
Elizabeth Hickman (CEO, AustinPx) and Dave Miller (CSO, AustinPx) examine how the rise of precision medicine is reshaping the role of CDMOs. As drug developers take on increasingly complex, patient-targeted therapies, formulation strategies must evolve to meet the moment. From multi-component ASDs to lipid-based delivery systems, CDMOs must now deliver tailored solutions that match each molecule’s unique properties and the specific needs of diverse patient populations. The article makes a clear case—precision medicine requires precision partnerships.
Outsourced Pharma: AustinPx Launches KinetiSol Equipment Lease Program
AustinPx has announced the launch of KinetiLease, a new program that allows pharmaceutical and biotech companies to lease KinetiSol research-scale equipment for in-house use. This gives drug developers direct access to AustinPx’s solvent-free, bioavailability-enhancing technology within their own R&D labs. The program includes comprehensive training, white glove delivery, and ongoing support. The first lease was signed with a top 10 global biotech company, which began using KinetiSol within weeks to screen and prototype multiple small molecule candidates. With its small footprint and proven results, KinetiSol is now more accessible than ever for internal development teams.
Building Resilience: CDMO Strategies for Drug Supply Chain Stability
In this article, AustinPx CEO Elizabeth Hickman highlights the critical role small-molecule CDMOs play in stabilizing today’s strained pharmaceutical supply chains. With more than 250 essential drugs in shortage, CDMOs must balance agility with scientific rigor to meet rising demand, regulatory pressures, and funding challenges. Hickman explores how high-science, high-touch strategies, scalable manufacturing, and patient-centric innovation such as IV-to-oral conversions and pill burden reduction can help CDMOs deliver resilient solutions and long-term value.
Pharma Trends and Predictions for 2025: An incoming CEO’s perspective
Elizabeth Hickman, CEO of AustinPx, outlines six key trends shaping the CDMO landscape in 2025. From the rise of GLP-1s and AI-driven molecules to growing interest in patient-centric dosage forms and IP-enhancing services, the article highlights how CDMOs must evolve to stay competitive. Hickman emphasizes the need for advanced formulation technologies, scalable processes, and a balance of scientific rigor and client-focused service. CDMOs that can reduce cost, accelerate timelines, and offer real value beyond manufacturing will be best positioned for the year ahead.
A Shifting CDMO Landscape: The Rise of High-Science, High-Touch
In a rapidly evolving drug development environment, capacity alone is no longer enough. In this article, AustinPx Chief Executive Officer Elizabeth Hickman unpacks how the CDMO landscape is shifting toward a “high-science, high-touch” model, one that prioritizes deep technical expertise alongside strong client collaboration. The article argues that success now hinges on more than just timelines and throughput. CDMOs must be built to solve complex formulation problems and deliver the kind of service that fosters long-term, strategic partnerships. This piece outlines what it takes to meet those expectations and why the most valuable CDMO relationships start with science and stay personal.
Breaking all the Rules - Pushing the Boundaries of Lipinski’s Rule of 5
Lipinski's Rule of 5 is a guideline in drug discovery that helps predict if a molecule is likely to be orally bioavailable. It's a set of criteria based on molecular weight, hydrogen bond donors and acceptors, and lipophilicity that, when violated, suggest a compound might have poor absorption or permeation. However, new molecules emerging from discover often deviate from Lipinski’s Rule of 5. AustinPx’s amorphous dispersion technology, KinetiSol™ has enabled hundreds of violators of Lipinski’s Rule of 5, while offering other advantages over other methods like spray drying and hot-melt extrusion.
CDMOs and Small Molecule Challenges: How small molecule-focused CDMOs can help companies navigate the impact of the Inflation Reduction Act
Elizabeth Hickman, AustinPx's Chief Business Officer, explores the far-reaching impacts of the Inflation Reduction Act (IRA) on the pharmaceutical industry in her recent article for The Medicine Maker. The IRA introduces significant challenges for small molecule drug development, curbing investments and reducing approvals despite growing patient demand for oral therapies. Hickman delves into how CDMOs are stepping up to fill the gap, providing adaptive and collaborative solutions to offset these challenges. By enhancing capabilities and offering tailored support, CDMOs play a pivotal role in ensuring the continued innovation of small molecule therapies.
KinetiSol™ Technology: A Sustainable and Efficient Revolution in Bioavailability Enhancement
The pharmaceutical industry is pushing the chemical drug space boundaries in search of new and more effective compounds. Consequently, the number of poorly soluble drugs has grown. To meet the challenge of poor solubility, pharma has developed processing technologies for the next generation of amorphous solid dispersions (ASDs). However, several ASD technologies utilize organic solvents, namely spray drying. These solvents can have a significant environmental impact, as well as greater manufacturing complexity and costs. AustinPx’s KinetiSol™ Technology has enabled the development of ASDs without the use of solvents, often with improved bioavailability facilitating lower doses compared to alternative ASD methods.
Pushing the Boundaries of Drug Development: Is Lipinski's Rule of Five Still Relevant?
Dave Miller, Ph.D., CSO of AustinPx, challenges the continued relevance of Lipinski’s Rule of Five (Ro5) in today’s pharmaceutical landscape. As technologies like AI and in-silico modeling reshape drug discovery, modern compounds often deviate from Ro5 guidelines yet demonstrate significant therapeutic potential. However, these nonconforming molecules can face hurdles in development due to solubility and scalability issues. KinetiSol Technology, AustinPx's advanced amorphous dispersion platform, offers a proven solution by enabling exceptional bioavailability and efficient manufacturing processes. By integrating KinetiSol early in development, AustinPx not only ensures these innovative candidates are optimized for clinical and commercial success but also redefines how the industry approaches drug development challenges.
Less Mess, Less Stress, Best Expressed: A Superior Alternative To Spray Drying
In a recent article, Chris Brough, CTO of AustinPx, highlights KinetiSol Technology as a superior alternative to spray drying for amorphous solid dispersions (ASDs). Unlike spray drying, which relies on organic solvents and nitrogen, KinetiSol uses a solvent-free process that directly dissolves drugs in polymers, preventing phase separation and enhancing stability and bioavailability.
KinetiSol streamlines the scale-up process by maintaining consistent parameters from lab-scale to commercial production, mitigating risks associated with drug degradation and particle size changes. KinetiSol also accommodates thermolabile APIs and offers a broader formulation toolbox, making it a versatile and efficient solution for modern pharmaceutical manufacturing.
Dave Miller: Pioneer in Pharmaceutical Innovation
Dave Miller, the Chief Scientific Officer (CSO) at AustinPx, is a leading figure in pharmaceutical science. His career path reflects his dedication, innovation, and commitment to excellence. From his early days as a chemical engineering student at the University of Texas to his key role at AustinPx, Miller’s journey is a story of scientific curiosity, significant discoveries, and leadership in drug formulation and manufacturing.
Miller’s career began in the labs of Professors Jim McGinity and Bill Williams at the University of Texas’ College of Pharmacy. Their mentorship provided not just guidance but a profound influence on Miller’s career path. After a short period as a process engineer in the chemical industry, Miller discovered his true passion: creating new medications to enhance the lives of patients.
Pharma Matters Q&A: AustinPx, Talking Next-Gen Amorphous Dispersion Technology
Dave Miller, Chief Scientific Officer of AustinPx, discusses in a recent Q&A why our innovative KinetiSol Technology will revolutionize amorphous solid dispersions (ASDs) for poorly soluble APIs. Unlike traditional spray drying, KinetiSol uses a solvent-free process, enhancing stability and bioavailability by preventing phase separation and directly dissolving drugs in polymers.
Miller explains how KinetiSol supports sustainable manufacturing by reducing solvent waste and offering economic benefits. The technology also accommodates thermally sensitive APIs and high melting point compounds, broadening the formulation toolbox. This versatile solution streamlines development timelines and ensures consistent quality from lab-scale to commercial production, making it a game-changer in the pharmaceutical industry.
Trends in amorphous solid dispersion drug products approved by the U.S. Food and Drug Administration between 2012 and 2023
In a recent publication, the trends in ASD drug products over a 12-year period from 2012 to 2023 were analyzed. The review highlights the role of AustinPx's KinetiSol Technology, a solvent-free process that provides significant advantages over traditional methods like spray drying. KinetiSol's ability to process thermolabile compounds and improve drug stability and bioavailability is emphasized as a key innovation in the field of amorphous solid dispersions.
The article notes that KinetiSol has been increasingly adopted for its efficiency in scale-up processes and its versatility in handling a wide range of drug formulations. This technology is also noted for addressing common challenges in the pharmaceutical industry, offering a robust solution for developing modern, patient-centric drug products.
How Difficult Is it to Scale Up an Amorphous Dispersion?
AustinPx's Justin Keen, Senior Vice President, Operations explores the scaling up of KinetiSol Technology. This innovative, solvent-free process rapidly transforms active pharmaceutical ingredients into high-quality amorphous solid dispersions, enhancing solubility and bioavailability. KinetiSol simplifies scale-up by controlling a single variable – shear rate – making the transition from lab-scale to commercial production seamless and efficient.
Keen highlights how KinetiSol addresses the challenges of traditional techniques like hot melt extrusion and spray drying, offering a more sustainable and efficient solution for drug development. At AustinPx, we leverage KinetiSol to improve poorly soluble drug candidates, accelerate development timelines, and achieve cost savings, driving the future of pharmaceutical manufacturing.
How prioritizing sustainability efforts yields long-term growth in drug manufacturing
Pharmaceutical companies that invest strategically in sustainability initiatives will differentiate themselves in a competitive market. Implementing these practices ensures a robust and long-term market position, enabling stakeholders across the value chain to overcome post-COVID challenges, innovate, and secure a more sustainable future for the industry.
With KinetiSol Technology, drug developers have a better option for developing ASDs and the opportunity to reduce their carbon footprint while accelerating development and lowering their manufacturing costs for final drug products.
How sustainable practices in pharma drive long-term growth
Embracing sustainability is not just socially responsible but also strategically beneficial, driving long-term financial returns and strengthening relationships with patients and the broader community.
At AustinPx, sustainability, innovation, and client-centricity are our pillars as a CDMO. Our KinetiSol Technology doesn’t just offer a more sustainable method for developing poorly soluble drug candidates, it provides improved performance, accelerated development timelines, and cost savings.
DCAT Sustainability Leaders
The first edition of The Sustainability Leaders, an eBook presented by DCAT, is now available. AustinPx is one of the sustainability leaders highlighted in this eBook, as well as the efforts of other DCAT Member Companies that are contributing positively to the environment. You shouldn't miss this opportunity to discover the praiseworthy initiatives being taken toward a sustainable future. Download the eBook now! https://lnkd.in/erM_rFCW