Analysis of Product-Related Impurities and Degradants in Biotech and Biological Products

Molecular variants in protein products require isolation and characterisation in order to identify the type of modification(s). At SGS M-Scan, product-related impurities and degradants are isolated and analysed using a combination of techniques described below.

Analysis of Modified Forms of Biotech and Biological Products

The desired protein product may often be oxidised, deamidated, have mismatched disulphide bridge patterns and other variable post‑translational modifications (e.g. glycosylated, phosphorylated, sulphated, acetylated). At SGS M-Scan, identification and analysis of modified forms can be performed using the following techniques:

  • Isoelectric Focusing (IEF) and Capillary Isoelectric Focusing (cIEF)

Analysis of Truncated Forms of Biotec and Biological Products

The desired product can often exist in a truncated or multiply truncated form. Identification and analysis of truncated forms (e.g. C-terminal Lysine variants) can be performed using the following techniques:

Analysis of Product Aggregates: Aggregation Analysis

Protein aggregation is a common problem encountered during manufacture and storage. It is considered to be undesirable because of potential immunogenicity (small aggregates) or problems with administration (large aggregates). SGS M-Scan utilises the following methods for aggregation analysis:

  • Analytical Ultracentrifugation (AUC)
  • Size Exclusion Chromatography with Multi-Angle Laser Light Scattering (SEC-MALLS)