• Van Gemert, Zac
• Bown, Mark

Abstract

Translational research is a challenge for both research institutions and industry. In Australia, there are more than 500 companies working in the Medical Technologies and Pharmaceuticals (MTP) sector. Many of these are small and medium enterprises (SME), which often struggle to achieve the transition from the R&D and laboratory scale to prototyping, scale-up, pre-clinical testing and industry evaluation. To address this challenge, CSIRO has established the Biomedical Materials Translational Facility (BMTF) with the support of the Science and Industry Endowment Fund (SIEF). The facility enables our partners to develop their ideas into functional prototypes using production methods that are scalable, while providing a tailored quality management system operation under ISO 9001:2015 and ISO 17025.Overcoming the barriers to enter the global MTP sector worth approx. $3 trillion annually is exemplified by our recent partnerships with local company Q-Sera Pty Ltd as well as Foldax Inc.In the case of Q-Sera, we established a scalable spray coating production method to deposit the company’s RAPClot technology onto commercially available blood collection tubes. This technology enables high quality serum collection and is now being realised commercially by Terumo Corporation. In the case of Foldax, a proprietary polymer tailored for heart valve applications was developed and synthesised in the facility. This has been a prerequisite for the manufacture of polymer heart valves, which are currently in clinal trials.We have learned that translational research can be successfully facilitated by suitable experience and infrastructure and that it is essential to work within an appropriate quality management framework.

Topics

• impedance spectroscopy
• polymer
• spray coating