(634b) Development of Lateral Flow Assays for Rapid Quantification of Cell Culture Targets

Chinese hamster ovary (CHO) cells are the most common host cell line for the production of biotherapeutics, including recombinant antibodies, bi-specifics and fusion proteins. With advances in technology, these cell factories are pushed to their limits in a controlled environment curated specifically for high growth and protein productivity. However, the high quantities of protein produced in these cells require high energy demands for protein synthesis, folding, secretion, and quality control. Additionally, inefficient mixing or oxygen transport across the large-scale reactors could potentially become a bottleneck resulting in hypoxic pockets that can impact overall cellular health and productivity.

Cell culture relies on daily bioreactor sampling to measure various process parameters, including cell viability and metabolite concentrations, such as glucose and lactate. It has been shown that higher levels of lactate can impact both cell growth and product quality. Rapid detection of abnormal cell culture parameters enables a proactive approach to implement corrective actions and improves overall process robustness.

Lateral flow assays have become an established analytical detection tool for various health screening needs, including pregnancy and COVID tests. However, little work has been done to generate assays focused on detecting targets relevant to CHO cell culture. In this work, we focused on developing lateral flow assays for the quantification of multiple cell culture metabolism targets for rapid, specific target detection of overall cell health. These assays can shed light onto the changing cell metabolism throughout the cell culture process and can allow for earlier detection of aberrant trends. With the growing demand for high volume production of biologics, lateral flow assays can enable process robustness and consistency to identify concentrations of targets that have major impacts on cell culture growth and productivity.