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.