BioPharmaSpec can support your aggregation requirements with a variety of techniques, providing you with an orthogonal understanding of how your biopharmaceutical product is aggregating.
For biopharmaceuticals, and monoclonal antibodies in particular, it is essential to assess for the presence of multimers and aggregates using a combination of methods. The regulatory authorities will usually request:
- Size Exclusion Chromatography (SEC) with Multi-Angle Laser-Light Scattering (SEC-MALS)
- Sedimentation Velocity Analytical Centrifugation (SV-AUC)
Aggregates can often be lost by non-specific binding to the SEC column or dispersed by the dilution of the product on the column and the shearing forces during the chromatography. Therefore, while defining your manufacturing processes or after making any changes, it is necessary to confirm the SEC results using a column free technique such as AUC.
BioPharmaSpec can provide both of these methodologies and will work with you to select the best method or combination of methods to assess the aggregation state of your product.