As the demand for novel protein therapeutics continues to increase, Contract Development and Manufacturing Organizations (CDMOs) and pharmaceutical companies must enhance efficiency and productivity within their cell line development (CLD) workflows. Developing stable cell lines to express increasingly complex protein modalities whilst maintaining high cell viability from single cell isolation throughout expansion to the bioreactor is a significant challenge, which is associated with common pain points.
These include, but are not limited to, lack of clonality assurance, death of clones during expansion leading to false-positive titers, and finally, expensive and time intensive methods for quantifying critical quality attributes (CQA), such as glycosylation profiles. Furthermore, overcoming these pain points with conventional methods results in an arduous and time intensive convergence of data from multiple instruments, increasing labor cost and limiting project throughput.
Advanced Instruments has taken a holistic approach to address key challenges when overcoming such inefficiencies and streamlining the clone selection process. In this talk, we will outline how the Solentim ICON™ utilizes powerful imaging technology for robust evidence of clonality, accurate confluence quantitation and rapid viable cell density assays, in addition to high-throughput, low-volume assays to rapidly measure both titer and glycosylation profiles of IgG and Fc-containing proteins.