Cell Line Development Inefficiencies and Streamlining the Clone Selection Process for Protein Biologic Production with the Solentim Ecosystem

As the demand for novel protein biotherapeutics continues to increase, Contract Development and Manufacturing Organizations (CDMOs) and pharmaceutical companies must enhance efficiency and productivity within their cell line development (CLD) workflows. The development of stable cell lines capable of expressing increasingly complex protein modalities, which maintain high cell viability throughout expansion from single cell to bioreactor, is a significant challenge that 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. Here, we will outline how the Solentim® Ecosystem 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.