Moravek’s services are compliant with FDA current good manufacturing practices (cGMP) and [14C]-labeled active pharmaceutical ingredients (APIs) produced under cGMP are suitable for use in clinical trials. The cGMP production of custom [14C]-labeled APIs begins with a conversation between you and our cGMP radiochemistry specialists. We will discuss all of the elements that are crucial to your clinical trial’s success, from clinical requirements to scheduling, to create an appropriate scope of work and ensure the success of your custom [14C]-labeled API.
cGMP Solutions Offered by Moravek
- cGMP [14C]Radiolabeling and API Manufacturing
For use in human clinical trials - Technical Batch Synthesis
Used to confirm synthetic pathway and establish radiolabeled compound stability - cGMP HPLC/UHPLC Method Transfer and System Suitability
Performed on one of our qualified HPLC or UHPLCs - cGMP Analysis and Purification of [14C]-Labeled APIs
NMR of various nuclides, MS, HPLC, UPLC, Karl Fischer, and other analytical services - Quality Assurance Release of [14C]-labeled API under cGMP
Quality Assurance review and approval of all cGMP production and analytical documentation prior to release of the API - cGMP Temperature Controlled Stability Studies
Storage in ambient, +4°C, -20°C, and -80°C with NIST traceable temperature recording and analysis with qualified HPLC or UHPLC systems - Comprehensive Logistics Services Storage, chain of custody, dispensing, shipping to clinics worldwide, and temperature tracking
To ensure that your 14C-labeled API successfully receives approval for clinical trials, we provide properly designed and implemented Quality Systems. Our Quality Assurance team works closely—with regulatory bodies and clients alike—to design and implement cGMP-compliant quality systems and standard operating procedures. This way, we can make sure that we satisfy all essential compliance activities including procurement, quarantine and release of reagents, manufacturing, isolation, quality control, chain of custody, temperature tracking, proper labeling, documentation, and release of cGMP 14C-labeled API while adhering to FDA cGMP guidance ICH Q7 Section 19.
Our quality systems and facilities have successfully passed all client and regulatory body Quality Assurance and Quality Systems audits and inspections. This also includes a cGMP inspection carried out by the California Department of Public Health. With our rigorous quality systems, Moravek is permitted to manufacture cGMP 14C labeling of active pharmaceutical ingredients (APIs) for clinical trials.
Production of APIs includes, but is not limited to:
Quality Systems
- Compliant with FDA cGMP guidance ICH Q7 Section XIX
- Suitable for use in clinical trials
- Quarantine & release of [14C] API by Moravek Quality Assurance
- Analytical method transfer
- Validation of analytical method(s)
Production
- Synthesis carried out in one of three highly engineered cGMP suites
- Verification of production area cleanliness by TOC
- SOPs for all key activities
- All new glassware for synthesis
- Quarantine & release of materials by Moravek Quality Assurance
- cGMP HPLC purification including all new media, tubing & glassware
- Production of a master batch record (MBR)
- Technical 14C-labeled batch prior to cGMP synthesis to aid in preparation of MBR and to be utilized for stability testing
Analysis & Documentation
- cGMP Certificate of Analysis certifying 14C-labeled API is suitable for use in clinical trials
- HPLC, MS, & NMR analysis (as appropriate)
- TSE/BSE statement
- Copy of notebook pages* (incl. reagent sources, lot numbers & procedures)
*notebook pages will not include proprietary information
Logistics & Customer Service
- Weekly email updates
- Weekly teleconferences
- Initial (kick-off) teleconference
- Confirmation of storage/packaging conditions
- Shipping & storage tracking
Shipping & Storage
- Aliquot preparation
- Domestic & International door-to-door shipment
- Secure cGMP storage at ambient, +4°C, -20°C, or -80°C
- Temperature logging during shipment