ICH Topic Q 6 B and the new EMEA Guideline on Development, Production, Characterisation and Specifications for Monoclonal Antibodies recommend analysis of biopharmaceuticals for protein aggregation.
Protein aggregation is a common problem encountered during manufacture and storage of proteins and is considered to be undesirable because of their potential immunogenicity (small aggregates) or due to potential problems with administration (large aggregates). A reliable method for assessment of Protein Aggregation is therefore required for the assessment of therapeutic products.
Currently, it is usual for the regulatory authorities to request Size Exclusion Chromatography (SEC) and a column free technique such as Analytical Centrifugation (AUC), to cross check the data obtained from SEC analysis. The requirement for confirmation of SEC results using a column free technique is due to the fact that aggregates can potentially be lost by non-specific binding to an SEC column.
SGS M-Scan utilizes Analytical Ultracentrifugation (AUC) and Size Exclusion Chromatography with Multi-Angle Laser Light Scattering (SEC-MALLS) to provide an assessment of aggregation for protein and glycoprotein therapeutics.