Analytical Development and Quality Control

LakePharma 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.