Product/Service

Radiolabeling Support

Source: ABC Laboratories

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.

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

 

Click Here To Download:
•ABC Laboratories Pharmaceutical Brochure
•Biotech Development Services Brochure