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

machinery-manufacturing
medical-device
robotics
software

Nr. of Employees

small (1-50)

Trace-Ability, Inc.

Santa Monica, California, United States, North America


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.


Services

Turn-key QC solution delivery (instruments, kits, training, service, support)

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
  • Show More (4)

Key Technologies

  • Plate reader-based optical assays
  • Robotic pipetting / automated liquid handling
  • Integrated automated rHPLC
  • 21 CFR Part 11–compliant data management software
  • Show More (4)

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