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Analytical Testing & Release

Curia offers full service GMP analytical testing that meet USP, Ph. EU., and FDA guidelines, with a full menu of analytical, bioassay, and microbiology services.

Curia Analytics
  • Whether your program requires a standard analytical approach to streamline upfront visibility, or flexibility to accommodate custom development, Curia’s in-house analytical testing labs can meet your needs.
  • Stability program supporting both development and GMP studies.

Highlights

  • Visual Appearance/Particle Testing USP <789/790>
  • pH/Osmolality USP <791/785>
  • Bioburden USP <61>
  • Endotoxin USP <85>
  • Sterility USP <71>
  • Mycoplasma USP <63 >
  • Adventitious agent testing
  • Other USP and Ph. Eu. methods upon request
  • Full Analytical Method Development and Validation
    • NGS sequencing methods for ITR constructs
    • Residual host cell protein (microBCA and ELISA)
    • Residual host cell DNA/RNA (std Gel Analysis, qPCR, and HPLC methods)
      cIEF and cIEX methods
    • HPLC/UPLC chromogenic methods
    • LC/MS purity methods
    • Mycoplasma by qPCR
  • Integrated fully with cGMP biorepository functions/services
  • Validated stability chambers with temperature and humidity control
  • Multiple storage chambers (Ambient, 5°C, -20°C, -80°C, LN2 -170°C)
  • Accelerated degradation studies
  • Full customization including multiple conditions, sampling intervals, and analytical tests

Ready to realize your product’s full potential on your schedule?

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