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A microfluidic approach to high throughput quantification of host cell protein impurities for bioprocess development

Jun Hyuk Heo*, Xiaodun Mou, Fengqiang Wang, John M Troisi, Christopher W Sandifer, Suzanne Kirby, Dennis Driscoll, Suzanne Mercorelli and David J Pollard

Background: Analysis of process-related impurities is critical for the control of biopharmaceutical processes and the quality of final biological products. Residual impurities in monoclonal antibody products such as host cell proteins (HCPs) increase the risk of immunogenicity and may directly affect drug potency. Commonly used HCP ELISA often involves complicated sample preparation, lengthy operation, and large volumes of reagent. To overcome these challenges, a fully automated CHO HCP assay was developed using a microfluidic platform (MFP) system and compared with existing plate-based ELISA for quantification of HCP in monoclonal antibody purification intermediates.

Results: The automated MFP based assay approach enabled an improved throughput (5–10-times faster), broader dynamic range (100-times) and decreased sample consumption, hands on time and duration for assay development compared with Tecan plate-based ELISA.

Conclusion: The newly developed microfluidic assay demonstrated its advantages over plate-based ELISA for the in-process HCP clearance monitoring and the quantification of final HCP in drug substance.