Trace-Ability, Inc.
Trace-Ability, Inc. specializes in automating quality control testing for radiopharmaceuticals, particularly PET tracers, to ensure compliance with cGMP regulations. Their flagship product, Tracer-QC, offers a fully automated, traceable, and efficient solution to streamline QC processes, reduce costs, and enhance safety in radiopharmaceutical production.
Industries
Nr. of Employees
small (1-50)
Products
Automated radiopharmaceutical QC system (plate reader + robotic pipettor with disposable kits)
A lab instrument system that uses robotic liquid handling and plate-reader optical assays (and optionally integrated HPLC) with single-use consumable kits to perform hands-free QC testing and generate audit-ready reports for PET tracer release.
Automated radiopharmaceutical QC system (plate reader + robotic pipettor with disposable kits)
A lab instrument system that uses robotic liquid handling and plate-reader optical assays (and optionally integrated HPLC) with single-use consumable kits to perform hands-free QC testing and generate audit-ready reports for PET tracer release.
Services
Provision of instruments, single-use kits, training, service and support as a turn-key offering through distribution partnerships.
Provision of instruments, single-use kits, training, service and support as a turn-key offering through distribution partnerships.
Expertise Areas
- Radiopharmaceutical QC automation
- Analytical method development for PET tracers
- Regulatory compliance for radiopharmaceutical production
- Automated HPLC integration and chromatogram analysis
Key Technologies
- Plate reader-based optical assays
- Robotic pipetting / automated liquid handling
- Integrated automated rHPLC
- 21 CFR Part 11–compliant data management software
News & Updates
April 2018 – First FDA approval for use of Tracer-QC.
First patent issued on Tracer-QC technology
2019 – First patent issued on Tracer-QC technology (US 10,309,947).
Tracer-QC IP protection expanded by new issued patent
2021 – Tracer-QC IP protection expanded by new issued patent (US 10,895,563).
April 2018 – First FDA approval for use of Tracer-QC.
First patent issued on Tracer-QC technology
2019 – First patent issued on Tracer-QC technology (US 10,309,947).
Tracer-QC IP protection expanded by new issued patent
2021 – Tracer-QC IP protection expanded by new issued patent (US 10,895,563).