Our custom radiosynthesis, purification, dilution, release, radiochemical stability testing, and QA reviewed documentation process consistently achieves cGMP compliance and assurance of quality.
All of the over 100 cGMP 14C labeled APIs provided by Moravek were suitable for use in early phase clinical trials in the US and around the world.
With one of the largest radiochemistry groups and state-of-the-art facilities and equipment, Moravek has the expertise and capacity to supply custom radiolabeled APIs that meet release specifications and are on time for your clinical trial.
In addition to cGMP radiosynthesis, solutions offered by Moravek include non-GMP radiosynthesis of carbon-14 and tritium labeled compounds, extensive GLP analytical services and a catalog of over 2,500 highly pure non-GMP radiolabeled compounds for research.
Solutions offered by Moravek include
• cGMP manufacture of 14C labeled APIs for clinical trials
• cGMP manufacture of 3H labeled, stable-labeled and non-labeled APIs for clinical trials
• Quality critical analytical services include UPLC, HPLC, MS, LC-MS, ICP-MS, Headspace GC, XRPD, and NMR
• Method transfer and method feasibility check under GLP or cGMP
• GLP custom synthesis of 14C, 3H, stable-labeled, and non-labeled compounds
• Agilent OpenLab Enterprise Content Management (ECM) system for 21 CFR Part 11 compliance
• Stability studies and storage utilize a 21 CFR Part 11 compliant Rees Scientific Environmental Monitoring System (EMS)
• Non-GLP grade custom synthesis of 14C, 3H, stable-labeled, and non-labeled compounds
• Purification by HPLC, flash and lobar chromatography, as well as preparative gas chromatography
• Catalog of over 2,500 exceptionally high quality non-GLP grade labeled compounds
• All operations are supported by 500 kW of Cummins PowerCommand cloud monitored backup power
• Comprehensive logistics services include storage, dispensing, shipping, chain of custody and temperature tracking