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Analytical Development
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