GEORGETOWN, Texas–(BUSINESS WIRE)–AustinPx, a contract development and manufacturing organization (CDMO) specializing in bioavailability enhancement of orally delivered small molecule drug candidates, and Microsize, a leading active pharmaceutical ingredient enhancement CDMO, today announced the strategic partnership to accelerate the commercial application of AustinPx’s KinetiSol® Technology platform. The collaboration will enable AustinPx’s clients to manufacture their late-phase clinical and commercial KinetiSol drug product intermediate at Microsize’s purpose built, FDA-inspected facility.
“Microsize provides our growing client base with an excellent, high-quality commercial partner for their late-phase and commercial KinetiSol production needs.”
KinetiSol is an innovative technology that utilizes frictional and shear energies to generate amorphous solid dispersions (ASD) in seconds, without the use of solvents. It has demonstrated higher exposure at lower doses with improved downstream processability compared to other ASD technologies. With its significantly smaller footprint, broader formulation design space for challenging molecules, and improved manufacturing economics, the KinetiSol platform is disrupting the ASD industry.
“AustinPx is excited to partner with Microsize, a like-minded client centric CDMO, on the commercial enablement of our KinetiSol Technology,” said Elizabeth Hickman, chief business officer of AustinPx. “Microsize provides our growing client base with an excellent, high-quality commercial partner for their late-phase and commercial KinetiSol production needs.”
As part of the agreement, AustinPx will transfer its proprietary KinetiSol equipment, software and know-how to Microsize’s Quakertown facility. In turn, Microsize will install and qualify the equipment for late-phase and commercial manufacturing within their cGMP manufacturing plant. Microsize will provide staff for scale-up and commercial stage KinetiSol production, as well as associated capabilities including quality control and assurance. The KinetiSol Technology is projected to be available at Microsize for GMP production by the end of 2024.
“Microsize is pleased to onboard such a powerful technology that has been shown to outperform alternative ASD technologies,” said TJ Higley, chief executive officer of Microsize. “Combining AustinPx’s KinetiSol clinical development and manufacturing experience with our scale up, commercial manufacturing and quality control testing expertise enables speed to market value creation for our mutual clients.”
About AustinPx
AustinPx, Pharmaceutics and Manufacturing, is a contract development and manufacturing organization (CDMO) providing analytical and formulation development services and cGMP manufacturing for small molecule drugs. AustinPx specializes in phase-appropriate development strategies, speed to clinic and market strategies, and bioavailability enhancement of poorly soluble molecules – including our next generation amorphous dispersion platform, KinetiSol® Technology. For more information, www.AustinPx.com.
About Microsize
For over 30 years, Microsize has been a pioneer in enhancing dissolution and bioavailability of Active Pharmaceutical Ingredients (API’s) and functional excipients via particle size reduction technologies including micronization. Operating from 100,000 square feet in the US-based state of the art, FDA inspected GMP facilities, Microsize has the experience and capabilities to rapidly develop, scale up and process API’s and excipients ranging from grams to multi-metric tons, including highly potent compounds (HPAPI’s). Microsize is THE partner of choice from small biotechs to big pharma to CDMOs, and is recognized for its speed, responsiveness, and high customer-touch business model. For more information, www.microsize.com
