SBIR Phase II: Development of a simple device that eliminates bottlenecks in radiopharmaceutical production
This Small Business Innovation Research Phase II project aims to deliver a cost-effective automated quality control (QC) system for manufacturing of radioactive drugs used in Positron Emission Tomography (PET). This system will replace current QC procedures, which involve 18 manual operations, 8 visual assessments, 6 devices, and 8 samples of radioactive drugs. The industry's current reliance on manual operation, subjectivity and untraceable records impedes progress in radioactive drug manufacturing and presents compliance risks. Therefore, introduction of an automated system combining all these tests on a single platform will facilitate adoption of PET imaging technology beyond top tier medical centers. By addressing a critical current Good Manufacturing Practice (cGMP) compliance need in radio-pharmaceutical production, which cannot be addressed with any other solutions available today, this solution is positioned for rapid adoption. After adopting this system, it is expected that manufacturing facilities will realize 20% operating cost reduction and 50% reduction in time spent on QC-related activities. A reduced cost of compliance associated with introduction of automated QC will further contribute to the adoption rate. This project will open the door to new applications of plate reader technology, an approach which has been traditionally confined to the fields of biochemistry and diagnostics. This Phase II effort includes four technical objectives. Firstly, the approach will be adapted to minimize the required sample volume. Methods developed in Phase I of the project required 0.5 ml of sample, a value which is not optimal for small manufacturers. To bring this value down to 0.2 ml, test sensitivity will be adjusted, keeping in mind the potential dynamic range trade-offs. Secondly, we will design a plastic consumable that supports adoption by a commercial manufacturer. Current plastic prototype components are only suitable for academic sites with highly-skilled personnel. To reduce the amount of training required, and to expand the applicability of this method, a new plastic component will be designed in order to further automate sample loading. Third, we will optimize the formulation of the reagents to achieve a one-year shelf life for the consumable kit. The shelf life of the reagents developed in Phase I remains unknown. Therefore, accelerated stability studies will be performed to estimate the rates of decomposition processes, and appropriate changes will be made to enhance shelf life. Finally, we will develop a pilot production process for the newly-designed kit, in order to support early installations. less This Small Business Innovation Research Phase II project aims to deliver a cost-effective automated quality control (QC) system for manufacturing of radioactive drugs used in Positron Emission Tomography (PET). This system will replace current QC procedures, which involve 18 manual operations, 8 visual assessments, 6 devices, and 8 samples of radioactive drugs. The industry's current reliance on manual operation, subjectivity and untraceable records impedes progress in radioactive drug manufacturing and presents complianc... more
Trace-Ability is a growing FDA-funded startup company developing breakthrough automated analytical technology for application in radio-pharmaceutical production. It currently leads a consortium of companies and research institutions in a program focused on industrial validation of the new technology. We are looking for qualified candidates for a postdoctoral position with a strong track record of scientific achievement and a PhD degree in analytical chemistry, physics, mathematics or engineering. The perfect candidate should be a result-oriented independent thinker capable of learning new concepts.
The candidate will be in charge of a project focused on development of a novel paradigm in optical analysis of chemical samples. The goal is to develop an analytical procedure whereby the purity of analyte can be determined only by analyzing its optical spectra without any chromatographic separation. Project success will depend on effective combination of knowledge in spectroscopy and mathematics with strong analytical skills. Understanding of chemistry and algorithm development should provide additional value. Experience in either spectroscopy or data analysis is a must.
We are looking for qualified candidates for a postdoctoral position with a strong track record of scientific achievement and a PhD degree in analytical chemistry, physics, mathematics or engineering. The perfect candidate should be a result-oriented independent thinker capable of learning new concepts.
Project success will depend on effective combination of knowledge in spectroscopy and mathematics with strong analytical skills. Understanding of chemistry and algorithm development should provide additional value. Experience in either spectroscopy or data analysis is a must.
