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 Quality Control

Quality Control Laboratory

The Quality Control (QC) laboratory directly adjacent to our Chemical GMP Synthesis Facility is overseen by an independent quality assurance manager.

Infrastructure:

  • Dedicated analytical laboratory
  • Equipped with qualified and validated instrumentation for the GLP/GMP release and characterization of APIs

QC Analysis of Intermediates, Drug Susbstances (DS) and CoA Release:

  • Identity

    • 1H-,13C-NMR
    • HRMS, MSn
    • UV-Vis spectroscopy 
    • IR spectroscopy
    • Refractive index
    • Optical rotation
    • Melting point
  • Purity

    • Chemical purity
    • Related substances
  • Quality Tests 

    • Heavy metals
    • Organic volatile impurities
    • Loss on drying
    • Residue on ignition
    • pKa determination
    • Raw materials release

Other Services:

  • Mass Spectrometry/NMR Spectrometry

    • Structural confirmation of API and intermediates
    • Structural determination of trace impurites
  • Release Testing for Oliogonucelotides/siRNA/Aptamers/Peptides 

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 Shared Resources

City of Hope and Beckman Research Institute have developed Shared Resources where a perceived need exists for specialized equipment, services, or expert consultation. Shared Resources with specialized instrumentation, and the expertise to apply these resources to research, have become increasingly important in recent years. Many of City of Hope's research support services are funded by the Cancer Center Support Grant (CCSG). 

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 Comprehensive Cancer Center

City of Hope Comprehensive Cancer Center - Photography by Julius Shulman and Juergen NogaiIn recognition of our excellence in a broad range of new approaches to cancer research and treatment—and our outreach to the community— the National Cancer Institute (NCI) has designated City of Hope a Comprehensive Cancer Center—one of just a handful of elite institutions nationwide.
 

 Beckman Research Institute - Home

Beckman Research Institute of City of Hope Renowned for transforming elusive clues into scientific discoveries, City of Hope's Beckman Research Institute stands as one of the nation’s premier centers for groundbreaking biomedical research. Scientific advances here in the fields of recombinant DNA technology, monoclonal antibodies and gene therapy have led to life-saving technologies and treatments for patients around the world.