Drug Product Intermediates of Bioavailablity Enhanced APIs, Powders, Finished Dose Forms and Clinical Packaging
AustinPx’s facilities and quality systems are designed to ensure quality and to meet global regulatory requirements, while maintaining flexibility for phase-appropriate processes and the rapid advance of your drug to the clinic. Our cleanrooms, capable of ISO 8, support a variety of manufacturing operations for oral dosage forms, including powders, capsules, tablets and suspensions.
DPIs, Powders, Capsules, and Tablets
Our manufacturing capabilities support preclinical through Phase II clinical trial materials.
- KinetiSol™ Technology for Amorphous Dispersions
- Packaging: Bottling and Clinical Labeling
GMP manufacturing is supported by our robust quality assurance system, project management team, quality control release and stability storage and testing. Through engineering, infrastructure, operational systems, quality systems and training, AustinPx is able to support the manufacturing of highly potent APIs. Over the last decade, our quality and EH&S systems have been successfully audited by some of the largest pharmaceutical companies. AustinPx has produced clinical trial material for early phase clinical trials in the US, Canada and Thailand.
Our KinetiSol Technology for the development and manufacture of amorphous dispersions is designed to facilitate efficient scale-up from preclinical development to commercialization. This innovative platform enables the manufacture of up to 40 kg/hr of drug product intermediate. Our GMP facilities can support early phase manufacturing and through our partnership with Catalent Pharma Solutions, we can support late phase scale up and commercial manufacturing. Learn more about KinetiSol
If you have any questions about our technologies, capabilities, or want to schedule an introductory discussion, contact us.