GMP [14C] API Manufacturing

Licensed by the Food and Drug Branch of the California Department of Public Health, Moravek holds the ability to prepare 14C or 3H labeled active pharmaceutical ingredients (API) for clinical trials. We are also permitted to handle schedule I-V classified compounds under DEA authority.

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GMP 14C API Manufacturing

Moravek is a leader in API GMP solutions, with the ability to prepare 14C and 3H radiolabeled APIs for Phases 0, I, and II mass balance and microdosing (Phase 0 and Phase I) studies. We perform GMP synthesis, purification, testing, and QA release in compliance with FDA Phase 0, I, and II GMP guidance (ICH Q7 Section XIX). In addition, we provide secure GMP storage conditions for our customers’ compounds.

In our GMP synthesis, purification, testing, and QA release processes, we analyze radiolabeled APIs that have been produced or purified under GMP conditions. These compounds are analyzed on qualified analytical instrumentation and are supplied with a complete batch record, which includes documentation of the synthetic, purification, and analytical processes from start to finish.

From synthesis to top-notch GMP storage conditions, all of Moravek’s work is carried out in 1 of our 4 certified GMP suites. APIs are analyzed using qualified HPLC, NMR, and MS instrumentation.

Production of APIs includes, but is not limited to:

Quality Systems

  • Compliant with FDA GMP guidance ICH Q7 Section XIX
  • 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 qualified equipment
  • 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