AustinPx
AustinPx is a contract development and manufacturing organisation (CDMO) that assists pharmaceutical developers in maximising the potential of their drug candidates.
Description
AustinPx is a client-centric Contract Development and Manufacturing Organisation (CDMO) dedicated to assisting pharmaceutical developers in realising the full potential of their drug candidates.
Founded in 2007 and headquartered in Georgetown, Texas, AustinPx specialises in overcoming challenges such as poor bioavailability and accelerated development timelines. The company offers a comprehensive suite of services, including preclinical development, formulation development, analytical services, and Good Manufacturing Practice (GMP) manufacturing of oral dosage forms. Their data-driven and technology-agnostic approach ensures that each formulation strategy is tailored to the unique physicochemical characteristics of the molecule and the client's objectives.
A hallmark of AustinPx is their proprietary KinetiSol™ Technology, a next-generation amorphous solid dispersion (ASD) platform designed to enhance the bioavailability of poorly soluble active pharmaceutical ingredients (APIs). This solvent-free, fusion-based process offers a smaller ecological footprint, broader formulation design space, and faster processing times compared to traditional ASD technologies.
Key Products and Services:
Preclinical Development: Molecule characterisation, preformulation testing, and formulation technology screening, including dry and wet granulations, amorphous dispersions, cyclodextrin complexations, particle size reduction, and lipid-based formulations.
Drug Development and Delivery
Formulation Development: Development of drug product intermediates and finished dosage forms such as solutions, suspensions, tablets, and capsules, with expertise in immediate and modified release formulations and bioavailability enhancement technologies.
Analytical Services: Comprehensive chemical analysis, dissolution testing, drug product test methods, and GMP stability studies to support preclinical through commercial stages.
Drug Development and Delivery
GMP Manufacturing: Capabilities include KinetiSol™ Technology, blending, milling, granulation, encapsulation, tableting, and packaging, supporting the production of clinical trial materials for Phase I/II studies.
KinetiSol™ Technology: An innovative platform for producing amorphous solid dispersions, significantly improving the bioavailability of poorly soluble drugs through a solvent-free, fusion-based process.
With over a decade of GMP manufacturing experience and a robust quality assurance system, AustinPx is committed to delivering flexible, responsive, and solutions-driven services. Their collaborative approach and dedication to scientific excellence make them a trusted partner in the pharmaceutical development and manufacturing industry.