non-GMP Syn

Pharmaceutical Development

Radiolabeling & Synthesis Solutions
non-GMP Services
CGMP Services
Phase 0 Development Support

CMC & 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

Non-CGMP Radiolabeling

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.

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

ABC's synthesis team offers 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.

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.