Moravek can prepare 14C and 3H radiolabeled APIs for Phases 0, I and II, mass balance and microdosing (Phase 0 and Phase I) studies.
Moravek is able to perform GMP synthesis, purification, testing, and QA release in compliance with FDA Phase 0, I and II GMP guidance (IQCH Q7A Section 19).
Radiolabeled APIs produced or purified under GMP conditions are analyzed on IQ\OQ analytical instrumentation and are supplied with a complete batch record, which includes documentation of the synthetic, purification and analytical processes from start to finish.
Finished 14C and 3H radiolabeled APIs can be sent to a contract research laboratory (CRO), to carry out the GMP procedures for the preparation of investigational medicinal product (IMPs).
GMP work is carried out in one of our three state-of-the-art certified GMP suites.
APIs are analyzed using IQ\OQ HPLC and MS instrumentation and NMR.
Production of APIs includes, but is not limited to:
- Compliant with FDA GMP guidance ICH Q7A
- Suitable for use in clinical trials
- Quarantine & release of 14C or 3H API by Moravek Quality Assurance
- Analytical method transfer
- Validation of analytical method(s)
- Synthesis carried out in one of three highly engineered GMP 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
- GMP HPLC purification including all new media, tubing & glassware
- Master batch record (MBR)
- Technical 14C or 3H batch prior to GMP synthesis to aid in preparation of MBR & to be utilized for stability testing
Analysis & Documentation
- GMP CoA certifying 14C or 3H 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
- Radiochemical and/or chemical stability data
- Utilization of equipment with current IQ/OQ
- Product labels with expiration date
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 GMP storage at ambient, +4°C, -20°C, or -80°C
- Temperature logging during shipment