Custom cGMP [14C] API Manufacturing

Moravek is licensed by the California Department of Public Health’s Food and Drug Branch to prepare 14C 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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The cGMP custom [14C] API manufacturing process begins with a conversation between you and our cGMP and radiochemistry specialists. We discuss all of the elements that are crucial to your clinical trial’s success, from clinical requirements to scheduling, in order to create an appropriate scope of work and ensure the success of your custom [14C] API manufacturing endeavor.

cGMP Solutions Offered by Moravek

  • cGMP [14C] API Manufacturing
    For use in human clinical trials
  • Technical Batch Synthesis
    Used to confirm synthetic pathway and establish radiolabeled compound stability
  • cGMP HPLC Method Transfer, Development and Validation
    Services include HPLC method transfer, method protocol, system suitability, and report, and are carried out utilizing six qualified HPLC and UPLCs
  • cGMP Analytical Services and cGMP Purification of [14C] APIs
    NMR of various nuclides, MS, HPLC, UPLC, Karl Fischer, and other analytical services
  • Quality Assurance Release of [14C] API under cGMP
    Quality Assurance review and approval of all cGMP production and analytical documentation prior to release of the active pharmaceutical ingredients (API).
  • cGMP Temperature Controlled Stability Studies
    NIST traceable temperature recording at +4, -20 and -80°C utilizing qualified HPLC systems
  • Comprehensive Logistics Services Storage, chain of custody, dispensing, shipping to clinics worldwide, and temperature tracking

To ensure that you successfully receive approval for clinical trials, we provide properly designed and implemented Quality Systems, including cGMP Standard Operating Procedures. In addition, our Quality Assurance team works closely with regulatory bodies and clients alike to design and implement cGMP-compliant quality systems and 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] API while adhering to FDA cGMP guidance ICH Q7 Section XIX.

Since we added cGMP ISO 7 Cleanrooms 2 and 3 in 2012, 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. Moravek is also permitted to manufacture cGMP [14C] and active pharmaceutical ingredients (API) 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
  • Master batch record (MBR)
  • Technical [14C] batch prior to cGMP synthesis to aid in preparation of MBR & to be utilized for stability testing

Analysis & Documentation

  • cGMP CoA certifying [14C] 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