Custom GLP Synthesis with Sulfur 35 [35S]

Moravek is licensed by the California Department of Public Health, Food and Drug Branch, for the preparation of 35S 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 GLP [35S] product manufacturing process begins with a conversation between you and Moravek radiochemistry specialists. Project scope of work and scheduling are all discussed. All elements essential to your project’s success will be discussed in order to arrive at an appropriate scope of work and to ensure the success of your GLP [35S] project.

GLP [35S] Solutions Offered by Moravek

Quality Systems

  • Compliant with FDA GMP guidance ICH Q7A
  • Technical Batch Synthesis (optional)
    Used to confirm synthetic pathway and establish radiolabeled compound stability
  • GLP Analytical Services and GLP Purification of [35S] Compounds
    NMR of various nuclides, MS, GC/MS, LC/MS, HPLC, UPLC and Karl Fischer analyses performed on IQ\OQ qualified instrumentation. (Other analytical services available)
  • 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 worldwide locations and temperature tracking.

Production of GLP [35S] Compounds includes, but is not limited to:

Quality Systems

  • Synthesis, purification and testing in accordance with GLP practices
  • Analytical method transfer (optional)

Production

  • Synthesis carried out in a clean, dedicated fume hood
  • Clean or new glassware for synthesis

Analysis & Documentation

  • CoA certifying 35S product was produced in accordance with GLP practices
  • HPLC, MS, & NMR analysis (as appropriate)
  • TSE/BSE statement (optional)
  • Copy of notebook pages* (incl. reagent sources, lot numbers & procedures)
    *notebook pages will not include proprietary information
  • Radiochemical and/or chemical stability data (optional)
  • Utilization of analytical equipment with current IQ/OQ

Logistics & Customer Service

  • Weekly email updates
  • Weekly teleconferences (optional)
  • Initial (kick-off) teleconference
  • Confirmation of storage/packaging conditions
  • Shipping & storage tracking

Shipping & Storage

  • Aliquot preparation
  • Domestic & International door-to-door shipment
  • Secure storage at ambient, +4°C, -20°C, or -80°C
  • Temperature logging during shipment (optional)

* Products produced under non-GMP guidelines are not suitable for clinical trials