Biologics

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Analytical Development and Quality Control

Curia offers a full service cGxP Analytical and QC workflow meeting USP, Ph. EU., and FDA guidelines with a full menu of analytical, bioassay, and microbiology services.

Highlights:

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  • 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 methods
  • LC/MS purity methods
  • Mycoplasma by qPCR
  • Integrated fully with cGMP biorepository services
  • Validated stability chambers with temperature and humidity control
  • Multiple standard storage modalities (Ambient, 5°C, -20°C, -80°C, LN2 -170°C)
  • Accelerated degradation studies
  • Customization including multiple conditions, sampling intervals, and analytical tests

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