CGMP Radiolabeling & Synthesis

Few contract research laboratories maintain the rigorous CGMP-compliant environment required to produce certified radiolabeled product suitable for human clinical trials. ABC Laboratories maintains four Class 10,000 CGMP Synthesis suites, a dedicated Quality Assurance staff and a group of analytical chemists with years of experience supporting labeled isotope studies. This unique capability complements in-house drug metabolism and impurity ID expertise and streamlines project management.

Early Clinical Support

• GMP API suitable for early clinical trials
• Radiolabeled (¹⁴C) GMP API for early clinical trials
• Radiolabeled (¹⁴C) GMP drug product formulations
• Analytical support dedicated to synthesis activities
  • Method development and early phase validation
  • Certificate of analysis generation