 The PA 800 plus IgG Purity and Heterogeneity Assay Kit (Part Number A10663) was designed in collaboration with biopharmaceutical analysts developing and manufacturing therapeutic MAb molecules. Assay methodology involves heat denaturation of IgG in the presence of SDS, followed by size separation using high-resolution capillary gel electrophoresis technology.
The IgG assay on the PA 800 plus features an internal system suitability control consisting of an IgG control standard with a designated quantity of non-glycosylated heavy chain to test both the resolution and quantitation suitability of the assay prior to running unknowns. This SDS-gel based method has been successfully implemented by different organizations in different locations with high precision.* The portability of the IgG Purity and Heterogeneity Assay was demonstrated in a 2006 study featuring multiple biopharmaceutical companies. *“A Series of Collaborations between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis.” Chromatographia 2006, 64, September (No. 5/6).
“Assay of IgG Purity and Heterogeneity Using High-Resolution Sodium Dodecyl Sulfate Capillary Gel Electrophoresis” (AIB A-1973A) - This bulletin describes development of a replaceable SDS-gel formulation and a separation methodology for purity and heterogeneity assessment of IgG and its isoforms. Click here for the IgG Purity/Heterogeneity Assay Kit Insert. Click here for more Information on the SDS-Gel and IgG Applications. |
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