GMP [14C] API Manufacturing

Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation, and 14C or 3H labeling of active pharmaceutical ingredients (API) for clinical trials. In addition, Moravek is allowed to handle schedule I-V classified compounds under DEA authority.
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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:

Quality Systems

  • 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)

Production

  • 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