Products and Services
Radiolabeling Support
Radiolabeling demands extensive training, experience, and an understanding of where on a molecule a label should be introduced to optimize stability and cost-efficiency.
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•ABC Laboratories Pharmaceutical Brochure
•Biotech Development Services Brochure
Radiolabeling Support
Radiolabeling demands extensive training, experience, and an understanding of where on a molecule a label should be introduced to optimize stability and cost-efficiency. ABC Laboratories maintains a staff of talented, Ph.D.-level radiosynthetic chemists who are known for their ability to introduce radioactive and stable isotope labels at positions optimal for supporting in-vitro and in-vivo DMPK studies. Our synthesis group supports our DMPK/Bioanalytical and CGMP analytical groups with research-grade and GLP materials—including APIs, internal and reference standards, intermediates and other materials used for impurity and metabolite identification.
•ABC Laboratories Pharmaceutical Brochure
•Biotech Development Services Brochure
•ABC Laboratories Pharmaceutical Brochure
•Biotech Development Services Brochure
Radiolabeling Support
Radiolabeling demands extensive training, experience, and an understanding of where on a molecule a label should be introduced to optimize stability and cost-efficiency. ABC Laboratories maintains a staff of talented, Ph.D.-level radiosynthetic chemists who are known for their ability to introduce radioactive and stable isotope labels at positions optimal for supporting in-vitro and in-vivo DMPK studies. Our synthesis group supports our DMPK/Bioanalytical and CGMP analytical groups with research-grade and GLP materials—including APIs, internal and reference standards, intermediates and other materials used for impurity and metabolite identification.
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.
Preclinical Support
- Radiolabled (14C) API for in-vivo and in-vitro studies
- API (tox lot) suitable for preclinical GLP studies
- Reference standard synthesis and qualification
- Stable-labeled API/metabolites (13C or 2H) for use as internal standard
- Impurity identification, isolation, synthesis and characterization
- Analytical support dedicated to synthesis activities
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
•ABC Laboratories Pharmaceutical Brochure
•Biotech Development Services Brochure
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