Isotope chemistry, isotope labeling, isotope labelling, radiolabelling, radiolabeling, c14 labelling, c14 labeling, gmp labelling, cgmp labelling, gmp labeling, cgmp labeling

Isotope Chemistry

Almac has extensive experience in the synthesis and analysis of stable and 14C  isotope labelled compounds.

We can label any compound at any stage between drug discovery and launch -including small moleculespeptidescytotoxics and antibody drug conjugates. Working from dedicated state of the art facilities, Almac provides a complete suite of solutions for your radiolabelling needs including:

  • Synthetic route design
  • Non-GMP supply of API for preclinical ADME studies
  • cGMP supply of API (Drug Substance) and IMP (Investigational Medicinal Product, also referred to as DP or Drug Product) for clinical AME studies
  • QC and analytical support Including method development and validation, method transfer and stability studies
  • Storage and repurification

MHRA certified for 14C  IMP and cGMP compliance, Almac is fully equipped to deliver an industry leading radiolabelling service which is high in quality, cost effective and true to your deadlines.

Download our library of expertise including case studies, presentations and publications

Almac Advantage

Experience

Over 15 years experience in the synthesis and analysis of stable isotope labelled compounds

Facilities

Dedicated, state of the art API and IMP facilities

Quality

MHRA accreditation for cGMP manufacture and IMP drug product manufacturing license

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