Capillary Electrophoresis capabilities expand
A thorough understanding of a biopharmaceutical product’s physicochemical properties is critical to achieving successful outcomes from development, through manufacturing and commercialization. Further, regulatory authorities require demonstration of a thorough knowledge of the protein’s structure. This is obtained primarily through extensive characterization studies. Once a knowledge base is established, these characteristics are typically monitored as critical quality attributes during bioprocess development and also used to set specifications for stability and release testing of the final product.
One of the primary techniques employed to analyze proteins is capillary electrophoresis (CE). This technique builds on traditional electrophoresis methods such as SDS-PAGE and Western Blot by utilizing a capillary tube and automating the analysis to transform it into an HPLC-like experiment. Protein species are separated based on their size-to-charge ratio. Critical properties such as the isoelectric point (pI) and charge heterogeneity are measured utilizing cIEF; whereas size and aggregation are studied utilizing cSDS.
Eurofins Lancaster Laboratories recently expanded its CE capacity within the Biochemistry Department due to increased demand from clients. A new lab module is being dedicated and equipped with 4 Beckman Coulter PA800 plus units, a Beckman Coulter PA800, a ProteinSimple iCE280, and a ProteinSimple iCE3. The Biochem Team has extensive experience developing and validating CE methods as well as transferring established methods into its lab to support stability and release testing. And Eurofins Lancaster Laboratories in Dungarvan, Ireland, also has a PA 800 plus and can perform method transfer and/or co-validation of methods developed in Lancaster, US, to support EU release testing of biopharmaceutical products.