Microfluidic platform for rapid biologics activity assessment using molecular charge modulation and electrokinetic concentration based receptor assays

Abstract

Biologics (biomolecule drugs) play a key role in modem medicine, yet assuring their quality and safety remains a major challenge for the biopharmaceutical industry. Developing a platform for rapid and reliable assessment of biologics activity is critical for quality control of biologics manufacturing and safety assurance. Herein we introduce a generally applicable platform for this purpose, using molecular charge modulation and electrokinetic concentration based receptor binding assays. This technology is homogeneous (immobilization-free) and overcomes many practical challenges of current immobilization-based binding assays. We developed various formats of assays for extracting the dissociation constants and dissociation rates of biologics toward their target receptors, which are directly related to the in vivo efficacy and duration of efficacy of biologics. We showcased the technology for rapid determination of biologics degradation, which is meaningful for assuring biologics safety. This work provides reliable biologics analysis comparable to state-of-the-art technologies with significantly less time (<1 h), reduced sample use, and simpler experimental setup, which holds promises as a platform for assuring the quality and safety of biologics at the point-of-care.