An essential part of drug development is understanding how a target molecule will react in the body. This understanding is typically gained through ADME studies:
- Absorption – what fraction goes into systemic circulation
- Distribution – does the target reach the site of action
- Metabolism – what the drug is turned into and what it comes out as
- Excretion – how the drug is removed from the body and how fast
What is Radiolabeling?
Radiolabeling is a common technique employed in ADME studies by drug developers to trace the life and journey of a target molecule; how it moves around and how it breaks down. The molecule is “labeled” with a radioisotope to enable tracking of its journey via imaging technology.
Carbon-14 (or 14C) is the most favored label choice when considering radiolabeling as it incorporates a 14C label selectively into the skeleton of the drug molecule, is detectable at very low concentrations, and its long half-life means no need for correction for radioactive decay.
Almac has extensive experience in the synthesis and analysis of stable (non radio-active) and 14C isotope labeled compounds – from drug discovery through to launch – we can label any compound at any stage, including small molecules, peptides and larger bio molecules.
Our custom radiolabeling service encompasses QC and analytical support, including method development and validation, method transfer and radiolabeling stability studies from our state-of-the-art facilities.
We are MHRA certified for 14C IMP manufacture and GMP compliance and we are fully equipped to deliver an industry-leading, cost-effective radiolabeling service.
Isotopic labeling imposes many synthetic challenges beyond those found in normal chemical synthesis. When the isotope is radioactive, this becomes even more demanding. That’s why we offer advice on the most appropriate label position for your molecule, including feasibility and metabolic stability.
Our strong track record in providing a complete suite of custom Radiolabeling solutions include:
- Biology & fermentation expertise
- QC & analytical support
- Stability studies & storage advice
- GMP & non-GMP stable & 14C-labelled API synthesize
- QC & analytical support selectAZymeTM enzymes for selective and mild transformation
- Labeled metabolites
- Storage & repurification
Our highly skilled team are enabled to offer custom radiolabeling services within a dedicated controlled access GMP facility using validated quality-critical equipment including:
- NMR and mass spectroscopy
- Cyclone Radio-TLC scanner
- Stromboli KF equipment
- Multiple Agilent HPLCs with radioflow, UV and fluorescence detection
- Tri-Carb 2900, 4900 and Topcount 12 channel scintillation analysers
- 2-8°C, -20°C and -80°C fridges and freezers
- Agilent GC
- 3, 5, and 6 point analytical balances
- X-ray powder diffraction (XRPD)