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:

Compendial Monograph Assays

  • Visual Appearance/Particle Testing USP <789/790>
  • pH/Osmolality USP <791/785>
  • Bioburden USP <61>
  • Endotoxin USP <85>
  • Sterility USP <71>
  • Mycoplasma USP <63 > (outsourced to approved partner)
  • Adventitious Agent Testing (outsourced to approved partner)
  • Other USP and Ph. Eu. methods upon request

Purity, Potency, Safety, Identity, and Residuals Assays in Multiple Formats

  • Sanger Sequencing
  • NGS Sequencing Methods for ITR Constructs (outsourced to approved partner)
  • Residual Host Cell Protein (microBCA and ELISA)
  • Residual Host Cell DNA/RNA (std Gel Analysis, qPCR, and HPLC methods)
  • cIEF and cIEX methods
  • HPLC purity methods
  • LC/MS purity methods (outsourced to approved partner)
  • Mycoplasma by qPCR
  • Phage Testing and Organism ID
  • Full Analytical Method Development and Validation
  • Virtually any R&D technology platform can be supported through full GMP development, qualification/validation, and recurrent testing

Fully Customized Stability Studies

  • Integrated fully with cGxP Biorepository Functions/Services
  • Validated Stability Chambers with Temperature and Humidity Control
  • Multiple Standard Storage Modalities (Ambient, 2-8°C, -20°C, -80°C, LN2 -170°C)
  • Accelerated Degradation Studies
  • Full Customization including multiple conditions, sampling intervals, analytical tests

Full Integration Across cGxP, Process Sciences, and R&D Assay Development Workflows

  • Fully-Customizable in process testing and release assay panel design
  • Standalone Testing Workflows or Integration with on-site Manufacturing Suites