From Confidence to Concern: The Shift in Spray Drying Sentiment
By: Dave Miller, CSO, AustinPx I spent April on the move, coast to coast, conference to conference, hearing more than what was on the agenda. I began the month on the East Coast at Interphex in New York City (where I had the privilege of moderating a session on Amorphous Manufacturing Technologies (session details here). From there, I continued on to…
Read MoreHow Difficult Is it to Scale Up an Amorphous Dispersion? (Xtalks article)
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…
Read MoreTrends in amorphous solid dispersion drug products approved by the U.S. FDA 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…
Read MorePharma 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…
Read MoreLess 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…
Read MoreWinning Strategies For Oral Dosage Form Development And Manufacturing
In a recent article, Dave Miller, CSO of AustinPx, highlights KinetiSol Technology as a superior alternative to spray drying for amorphous solid dispersions (ASDs). Failure to identify a compound’s red flags—bioavailability, stability, processability, etc.—early in development often manifests as program delays or failures. These setbacks can be avoided through complete molecular characterization, which can de-risk development and…
Read MorePushing 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…
Read MoreBeyond Solvents: The Future of Sustainable Amorphous Dispersion Development
AustinPx CEO Elizabeth Hickman examines why greener amorphous solid dispersion (ASD) development requires more than simply reducing solvent use. As sustainability expectations grow, she explains how cost, risk, timelines, and long-term asset value are all shaped by the complexity of the manufacturing process itself. The article explores how traditional solvent-based ASD approaches can introduce added…
Read MoreChoosing the Best Amorphous Dispersion Path Before It Costs You
AustinPx examines why early amorphous solid dispersion (ASD) technology selection can have a major impact on cost, timelines, and long-term product value. As more oral small molecules face poor solubility, low exposure, food effect risk, and dose form challenges, a single technology screen may not provide enough information to choose the strongest development path. The…
Read MoreHow CDMOs Turn “Undruggable” Into “Developable”
AustinPx CEO Elizabeth Hickman and CSO Dave Miller examine how precision medicine, AI, and advanced discovery tools are expanding what is possible in drug development while creating new formulation and manufacturing challenges. As researchers pursue more targeted molecules, many candidates come with difficult chemistry, including poor solubility, low permeability, stability concerns, and scale-up risk. The…
Read MoreRe-Thinking the Pipeline: Development in the Age of AI
In this article, AustinPx’s CEO, Elizabeth Hickman, examines how artificial intelligence is reshaping the front end of drug discovery and what that shift means for development. AI-driven tools are enabling researchers to design and evaluate increasingly complex molecules at unprecedented speed, expanding access to targets that were once considered undruggable. However, many of these AI-designed…
Read MoreSolving the Problem of Insolubility: The Medicine Maker Interview Series (3-part)
In this three-part interview series with The Medicine Maker, AustinPx CEO Elizabeth Hickman and CSO Dave Miller examine the growing challenge of poorly soluble drug candidates and what it means for modern drug development. As advances in AI-driven discovery, structure-based design, and in silico screening unlock increasingly complex molecules, formulation and manufacturing strategies must evolve to…
Read MoreAI Might Find the Molecule, but Delivery Decides Whether it Becomes a Medicine
In this article, AustinPx Chief Scientific Officer Dave Miller examines how the rapid expansion of AI-enabled drug discovery is reshaping the pharmaceutical pipeline. While advanced computational tools can now identify and optimize candidate molecules at unprecedented speed, many of these compounds present significant challenges once they transition from virtual design into experimental development. Issues such…
Read MorePushing the Boundaries: Overcoming Formulation and Manufacturing Challenges (eBook w/ Pharmaceutical Technology)
Winning Strategies For Oral Dosage Form Development and Manufacturing. An eBook in partnership with Pharmaceutical Technology. Oral solid dose (OSD) formulation development must adhere to common considerations, such as project timelines, facilitating CDMO/client transparency and overcoming regulatory challenges. However, development’s difficulty often is compounded by numerous factors such as API supply constraints, challenging physiochemical properties,…
Read MorePrecision 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…
Read MoreBreaking 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…
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