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.
Clinical Support
- GMP API suitable for early clinical trials, including Phase 0 microdosing studies
- 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
ABC possesses deep experience with all types of chemistries: Lithiation, Grignard, epoxidation, nitration, metal catalysis--as well as chiral separation and asymmetric synthesis...and all types of compounds, including carbohydrates, polymers, amino acids, peptides, nucleosides, nucleotides, and steroids.