cGMP [3H] API Manufacturing and Purification

Licensed by the Food and Drug Branch of the California Department of Public Health, Moravek is permitted to prepare 3H label APIs for clinical trials and handle schedule I-V classified compounds under DEA authority.

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cGMP 3H API Manufacturing and Purification

Our cGMP 3H API manufacturing and purification services include the preparation of 3H radiolabeled APIs for Phases 0, I, and II mass balance and microdosing (Phase 0 and Phase I) studies. We also perform cGMP testing, synthesis, purification, and QA release in compliance with FDA Phase 0, I, and II cGMP guidance (ICH Q7 Section XIX).

In the cGMP 3H API process, radiolabeled APIs that have been produced or purified under cGMP conditions are carefully examined on qualified analytical instrumentation. These APIs are also supplied with a complete batch record that includes documentation of the synthetic, purification, and analytical processes from start to finish. Finished 3H radiolabeled APIs can be sent to a contract research laboratory (CRO) to undergo preparation for investigational medicinal products (IMPs).

All of our work, from cGMP testing to QA release, is carried out in 1 of our 4 certified cGMP suites. APIs are analyzed using qualified HPLC and MS instrumentation and NMR.

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 3H 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
  • Master batch record (MBR)
  • Technical 3H batch prior to cGMP synthesis to aid in preparation of MBR & to be utilized for stability testing

Analysis & Documentation

  • cGMP CoA certifying 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 cGMP storage at ambient, +4°C, -20°C, or -80°C
  • Temperature logging during shipment