Biophysics

Analytical Ultracentrifugation (AUC)

Biophysical testing provides rigorous evaluation of vectors used in gene and cell therapy. SV-AUC (Sedimentation Velocity AUC) is the gold standard for determining the extent to which gene therapy vectors have incorporated the gene of interest – a critical quality attribute.

AUC also enables detection of aggregates, stability testing and size distribution of lipid nanoparticles, monoclonal antibodies, antibody drug complexes, etc.

In collaboration with many clients, we have expanded our AUC testing repertoire to also offer density gradient equilibrium AUC.

BioAnalysis is the only firm providing precise AUC data collected with Good Manufacturing Practices (GMP) in a laboratory that includes a whopping seven AUC instruments. World-leading BioAnalysis experts provide complete AUC analyses including easy-to-understand interpretation and reporting.

SV-AUC is based on first principles (no modification of the molecule under study) and is the only technique that provides absolute quantitation, size distribution, and other hydrodynamic properties in a single experiment.

AUC Outputs

Percent of empty, partial and full capsids with gene of interest | DNA:Capsid Ratios | IntraCapsid Heterogeneity | Stability Indicating Assays | Contaminants | Aggregation | Size Distribution (apparent molecular weights, shape and sedimentation coefficients)

Dynamic Light Scattering

Dynamic Light Scattering (DLS) is a fast and sensitive semi-quantitative method for determining aggregation and particle size. BioAnalysis supports DLS testing with formulation development, process development, release and stability testing.