Global intercompany assessment of ICIEF platform comparability for the characterization of therapeutic proteins
An international team spanning 19 sites across 18 biopharmaceutical and in vitro diagnostics companies in the United States, Europe, and China, along with one regulatory agency, was formed to compare the precision and robustness of imaged CIEF (ICIEF) for the charge heterogeneity analysis of the National Institute of Standards and Technology (NIST) mAb and a rhPD-L1-Fc fusion protein on the iCE3 and the Maurice instruments. This information has been requested to help companies better understand how these instruments compare and how to transition ICIEF methods from iCE3 to the Maurice instrument. The different laboratories performed ICIEF on the NIST mAb and rhPD-L1-Fc with both the iCE3 and Maurice using analytical methods specifically developed for each of the molecules. After processing the electropherograms, statistical evaluation of the data was performed to determine consistencies within and between laboratory and outlying information. The apparent isoelectric point (pI) data generated, based on two-point calibration, for the main isoform of the NIST mAb showed high precision between laboratories, with RSD values of less than 0.3% on both instruments. The SDs for the NIST mAb and the rhPD-L1-Fc charged variants percent peak area values for both instruments are less than 1.02% across different laboratories. These results validate the appropriate use of both the iCE3 and Maurice for ICIEF in the biopharmaceutical industry in support of process development and regulatory submissions of biotherapeutic molecules. Further, the data comparability between the iCE3 and Maurice illustrates that the Maurice platform is a next-generation replacement for the iCE3 that provides comparable data.
Keywords: Antibody; Biopharmaceutical analysis; Fusion protein; ICIEF; Imaged capillary Isoelectric focusing.
Authors: Seth Madren, Will McElroy, Kristin Schultz-Kuszak, Boris Boumajny, Yao Shu, Sabine Sautter, Helen C Zhao, Abby Schadock-Hewitt, Chris Chumsae, Nancy Ball, Xiaoying Zhang, Kimberly Rish, Shukui Zhang, Christine Wurm, Sumin Cai, Scott P Bauer, Cinzia Stella, Laura Zheng, Brian Roper, David A Michels, Gang Wu, Bostjan Kocjan, Matej Birk, Simon Erik Erdmann, Xiaoping He, Brad Whittaker, Yvonne Song, Hannah Barrett, Kevin Strozyk, Ye Jing, Long Huang, Vishal Mhatre, Paul McLean, Tiantian Yu, Huijuan Yang, Minna Mattila
Dominik Brandstetter, Constanze Helbig, Kentaro Osawa, Hiroyuki Minemura, Yumiko Anzai, Tetsuo Torisu, Susumu Uchiyama, Tim Menzen, Wolfgang Friess, Andrea Hawe