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Custom cGMP [14C] API Manufacturing

Moravek is licensed by the Food and Drug Branch of the California Department of Public Health. We are approved to prepare 14C labeling of active pharmaceutical ingredients (API) for clinical trials and handle schedule I-V classified compounds under DEA authority.
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Custom cGMP 14C API Manufacturing

The cGMP [14C] API manufacturing process begins with a conversation between you and Moravek cGMP and radiochemistry specialists. We will discuss your project’s scope of work, clinical requirements, scheduling, and other cGMP solutions. To ensure the success of your cGMP API campaign, we also discuss good manufacturing practices for pharmaceutical ingredients. Some of the cGMP solutions that we offer include:

  • cGMP [14C] API Manufacturing
    For use in clinical trials with humans
  • Technical Batch Synthesis
    To confirm synthetic pathways and establish radiolabeled compound stability
  • cGMP HPLC Method Transfer, Development and Validation
    Services include HPLC method transfer, method protocol, system suitability, and reporting. We carry out these services using 6 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 API
  • cGMP Temperature Controlled Stability Studies
    NIST traceable temperature recording at +4, -20 and -80°C utilizing qualified HPLC systems
  • Comprehensive Logistics Services
    Services include storage, chain of custody, dispensing, shipping to clinics worldwide, and temperature tracking

Properly designed and implemented Quality Systems, including good manufacturing practices for pharmaceutical ingredients, are essential to ensuring that your cGMP [14C] API manufacturing campaign will succeed in receiving approval from regulatory bodies for use in a clinical trial.

The cGMP Quality Assurance Team at Moravek has over thirty years of industry experience in cGMP API Manufacturing. Working closely with regulatory bodies and dozens of clients, our QA Team designs and implements comprehensive, cGMP-compliant, high-quality systems and operating procedures. These solutions consistently satisfy all essential compliance activities including:

  • Procurement
  • Quarantine and release of reagents
  • Manufacturing
  • Isolation
  • Quality control
  • Chain of custody
  • Temperature tracking
  • Proper labeling
  • Documentation
  • Release of cGMP [14C] API

We perform these services all while adhering to FDA cGMP guidance ICH Q7 Section XIX.

Since the addition of cGMP ISO 7 Cleanrooms 2 and 3 in 2012, our cGMP Quality Systems and facilities have successfully passed all client and regulatory body Quality Assurance audits and inspections, including a cGMP inspection carried out by the California Department of Public Health. Moravek has passed all Quality Systems audits and inspections and was approved to manufacture cGMP [14C] and API for clinical trials. Since 2012, we have manufactured over 100 cGMP [14C] APIs: all of which have met both our client’s Quality Assurance criteria as well as the acceptance criteria of the clinical trial regulatory bodies.

Moravek welcomes your Quality Assurance onsite inspection of our cGMP facilities and systems. Please contact us to schedule an inspection.

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