Biophysical Characterization

Light scattering is an essential part of any biophysical characterization lab for biotherapeutics, and is recognized by the FDA as a key technology for regulatory filings. Key applications include:

Aggregation

Applying orthogonal techniques based on light scattering and other instruments provided by Wyatt, analytical support labs can support regulatory filings with thoroughly validated, extended analysis of soluble and insoluble sub-micron aggregates. These techniques are:

SEC-MALS for robust characterization of the mass and size distributions of soluble, irreversible aggregates

FFF-MALS for robust characterization the mass and size distributions of soluble and insoluble, irreversible aggregates

Batch DLS for rapid testing of size distributions for soluble and insoluble, reversible and irreversible aggregates

CG-MALS for characterization of reversible aggregates or oligomers, as well as validation of SEC-MALS for loss of aggregates on the column.

Conjugation

Triple detection by UV-MALS-dRI determines the composition as well as molar mass distributions of:

Protein-polysaccharide conjugated vaccines

PEGylated proteins

Antibody-drug conjugates

glycoproteins

VLPs with DNA/RNA payloads

With the addition of a WyattQELS™ DLS module, the size distributions may be determined as well.

Chemical disposition: ELS determines charge state and so is an important indicator of surface chemistry.

Functionality: CG-MALS is a powerful technique for in-depth characterization of biomolecular interactions such as drug-target binding, without labeling or immobilization. Since it measures molar mass directly, it is particularly versatile for a range of valencies and self- as well as hetero-association.

Agregasyon

Konjugasyon

glikoproteinler