Analytical Testing & Release

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.

Curia GMP Analytics

  • We use a standardization approach for analytics offered to streamline upfront feasibility and shortening the distance to qualification. We utilize the flexibility to accommodate varying analytical methods and custom development as required.
  • Our stability support encompasses Developmental and packaging studies, stability protocol design, chromatographic analysis, wet chemistry and dissolution testing.
  • Close program oversight is in place from quoting phase through GMP Release of Materials by members of the QA team and close collaboration with the development aspects of the program to monitor Risk, Alignment with GMP manufacturing goals and IND submission needs for early stage clients. 
  • We deliver thoughtful, organized Documentation for GMP activities including Batch Records, Custom Analytical SOPs and Qualification Protocols/Reports, Raw Materials, and Raw Data.

Hightlights

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

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