Overcoming limitations of ELISAs in process-related impurity testing  


Webinar Description:

Host cell protein (HCP) process-related impurities in biotherapeutics manufacturing are a major process and regulatory concern, due to their potential impact to product safety, efficacy, and quality. Immunoassays have been the mainstay of HCP measurement, with ELISAs the most common format and considered the gold standard of analysis. However, the drawbacks of ELISAs include lengthy assay incubation steps, frequent manual interventions, limited sensitivity, and narrow dynamic range, delaying time-critical decision making.

This webinar describes the evaluation and implementation of Gyrolab technology for overcoming the limitations of conventional ELISAs. The Gyrolab microfluidic-based, miniaturized immunoassay format uses a novel flow-through affinity column format paired with nanoliter-scale microfluidic structures contained within a CD format. Centrifugal and capillary forces are utilized to steer liquid flow through the affinity column to perform the immunoassay. The assay workflow is automated, with laser-induced fluorescence detection, eliminating the need for incubations and operator interventions.

Transfer of the HCP ELISA to Gyrolab format expanded the assay dynamic range to 1 to 1000 ng/mL, and the increased sensitivity reduced sample dilutions and repeat analysis. Time to data was reduced to 2 hours. Gyrolab Technology demonstrated capability as a platform HCP method for early stage bioprocess development

Learning Objectives:

  • Understand the plate-based assay vs Gyrolab experience
  • Understand Gyrolab Viewer profile data analysis and troubleshooting experiences


Utku Hasbay

Utku Hasbay
Bioassay Scientist, Bio-Process Development Department
Takeda Pharmaceuticals

Utku Hasbay acquired his M.S. in Cellular and Molecular Biology in the aquatic toxicology laboratory at St. Cloud State University, Minnesota. He specialized in contaminants of emerging concern and their impact on aquatic organisms. His master’s research served development of adverse outcome pathways. After acquiring his M.S., he started working in the industry at Pharmgate Biologics for research and development of animal vaccines. Currently, he is part of the in-process analytics team at Takeda Pharmaceuticals and testing process related impurities.