A Series of Collaborations Between Various Pharmaceutical Companies and Regulatory Authorities Concerning the Analysis of Biomolecules Using Capillary Electrophoresis

• DOI: 10.1365/s10337-006-0003-y
• Publication Date: 2006-08-09T09:36:10Z
• Authors: B. Nunnally; S. S. Park; K. Patel; M. Hong; X. Zhang; S. -X. Wang; B. Rener; A. Reed-Bogan; O. Salas-Solano; W. Lau; M. Girard; H. Carnegie; V. Garcia-Cañas; K. C. Cheng; M. Zeng; M. Ruesch; R. Frazier; C. Jochheim; K. Natarajan; K. Jessop; M. Saeed; F. Moffatt; S. Madren; S. Thiam; K. Altria
• Keywords: Biopharmaceutical; Biomolecule; Bovine serum albumin; Expert opinion

An international project team (including members from US, Canada and UK) has been formed from a number of interested biopharmaceutical companies and regulatory authorities to conduct a cross-organisation collaboration exercise. The results from this exercise demonstrate the robustness of CE-SDS across eight different organisations that used instruments of the same equipment model, the same reagents, and the same methodology. Data generated from the analysis of a series of molecular weight markers showed very good precision with regards to relative migration time (RMT) both within and between organisations. The apparent molecular weight of bovine serum albumin (BSA) was measured with good precision to within approximately 2% RSD across the participants. A representative IgG sample showed similar results with regards to relative migration time of its 3 main components, IgG Light Chain, IgG Non-glycosylated Heavy Chain, and IgG Heavy Chain. Fractional peak area for each peak also showed good agreement, with less than 9% RSD for all peaks. This exercise will facilitate both increased regulatory and industrial opinion of CE for biopharmaceutical analysis.