Use of SDS-PAGE for Residue Protein Determination

In recent years, Almac has increasingly integrated biocatalysis into the manufacturing of active pharmaceutical ingredients (APIs). These biologically driven processes, while efficient and sustainable, inherently introduce host cell derived impurities and recombinant proteins into the production stream. As a result, the detection and quantification of residual proteins-host cell proteins (HCPs) and recombinant enzymes-are critical to ensuring the quality, safety, and efficacy of the final API.

Absorption based methods for protein analysis, such as ELISA, Bradford, and BCA assays, often face limitations in specificity, sensitivity, or compatibility with complex sample matrices. To overcome these challenges, Almac has developed a robust and versatile sodium dodecyl sulfate– polyacrylamide gel electrophoresis (SDS-PAGE) method tailored to accommodate a wide range of APIs and intermediates. This technique enables both qualitative and semi-quantitative assessment of residual proteins, offering a reliable alternative for routine quality control in biocatalytic API production.