Radiolabeling requires extensive training and expertise of locating a metabolically stable position on the molecule to optimize its stability and cost-efficiency. VxP Pharma can provide you with qualified organic chemists who will introduce radioactive and stable isotope labels at positions optimal for supporting human clinical trials, as well as preclinical and non-clinical studies.
We support the full range of DMPK, bioanalytical and analytical studies with GMP/GLP and research-grade certified materials for your APIs, reference materials, intermediates and other standards used for impurity and metabolite identification. We can provide technical assistance that accompanies in-house drug metabolism, impurity ID and environmental assessment expertise, and our laboratory managers can provide seamless communication throughout the duration of your development program.
cGMP Radiolabeling & Synthesis
At VxP Pharma, we maintain a cGMP-compliant environment required to produce certified radiolabeled products suitable for human clinical trials. Our facility maintains multiple classified cGMP synthesis suites, as well as additional support by our full service Analytical Chemistry Laboratory and Quality Assurance Department who have years of experience supporting labeled isotope studies.
Clinical Support
- GMP API suitable for early clinical trials, including micro-dosing studies
- Radiolabeled (14C) GMP API for early clinical trials
- Radiolabeled (14C) GMP drug product formulations
- Analytical support dedicated to synthesis activities
- Method development/validation
- Certificate of analysis generation
GLP Radiolabeling: Supporting Non-clinical & Pre-clinical Studies
Non-clinical Support
- Radiolabeled (14C and 3H) active ingredient (AI) for in-vivo (plant and animal) and in-vitro metabolism studies, 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) API for in-vivo/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
Our state-of-the-art labs are staffed by some of the best trained and most experienced subject matter experts in the field.