AustinPx is located in Austin, Texas and has over 30,000 sq feet of development, manufacturing, warehousing, stability and support space. Our GMP manufacturing suites and 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 classification, support a variety of manufacturing operations for oral dosage forms, including powders, capsules, tablets and suspensions.
AustinPx can produce oral drug product for the non-GLP studies, GLP toxicology studies, and Phase I/II clinical studies. Our validated equipment includes the range of equipment to support oral dosage forms. 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.
Drug Product Manufacturing:
- Milling and Blending
- KinetiSol™ Technology for Amorphous Dispersions
- Powder for reconstitution
- API in a Capsule
- Powder and Liquid Filled Capsules
- Coated or Uncoated Tablets
- For GLP and non-GLP studies
- For Phase I/II clinical studies
- Bottling and Labeling