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SERVICES » Pharmaceutical Development » Syn
The ABC Difference

 

Pharmaceutical Development

Biotech Services
Method Development & Validation
Stability & Release Testing
Analytical Support
Biomarker Panel Analysis
Peptide Mapping

DMPK and Bioanalytical Solutions (GLP)
Method Development & Validation
In-vitro DMPK Services
In-vivo DMPK Services
Bioanalytical Testing

Radiolabeling and Synthesis Solutions
Radiolabeling with GLP Certification
CGMP Services
Phase 0 Development Support
       Management

CMC and QC Solutions (CGMP)
Method Development & Validation
Extractables/Leachables Studies
Trace Analysis & Structural Chemistry
Stability Programs and Release Testing

Drug Development Consulting

Environmental Assessments

Seamless Project Management
through Strategic Partnerships

Radiolabeling with GLP Certification

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'  staff of talented, mostly Ph.D.-level radiosynthetic chemists are known for their ability to introduce radioactive and stable isotope labels at positions optimal for supporting GLP non-clinical and preclinical studies.

Non-clinical Support

  • Radiolabled (14C and 3H) active ingredient (AI) for in-vivo (plant and animal) and in-vitro metabolism studies, as well as environmental fate and effects testing
  • Reference standards
  • Stable-labeled  (13C, D, 15N) API/AI/metabolites for use as internal analytical standards

Preclinical Support

  • Stable-labeled API/metabolites (13C, D, 15N) Active Pharmaceutical Ingredient (API) for in-vivo and in-vitro drug metabolism and pharmacokinetic studies
  • API suitable for toxicological studies
  • Reference standard synthesis and qualification
  • Stable-labeled API/Ai/metabolites for use as internal standards
  • Impurity identification, isolation, synthesis and characterization

ABC can synthesize materials for GLP laboratory studies conducted at ABC or ship to the destination of your choice. Our fully trained materials management staff will package your materials and insure they arrive safely to their destination.

Radiolabeling Synthesis

Few can offer ABC's combination of compounding, formulation and dose fill (solid oral and sterile IV) services, as well as CGMP expertise in supporting human mass balance/ADME studies.