Screen and identify mAbs faster with streamlined analytical methods

Launching a therapeutic antibody requires years of drug discovery research, clinical trials, and scaling up for commercialization. One of the most crucial yet challenging steps in creating a therapeutic antibody is cell line development (CLD). It often requires the collaboration of multiple teams specializing in different areas of research, such as genomics, PD, and analytics.

Initially, genes of interest are transfected into cells. After successful transfection, several thousand clones are generated. These clones undergo assessment for critical quality attributes in analytical labs to ensure consistent drug quality, efficacy, and safety. This introduces a significant bottleneck in the CLD process because immense amounts of time and resources are needed to assess the critical quality attributes of each clone.

A clever approach for tackling the bottleneck caused by the high numbers of clones at this stage is the incorporation of a screening process within the CLD lab itself to identify high-producer cell lines. This strategy allows shortlisting of a smaller pool of candidates for further evaluation in the analytical lab, improving turnaround time. IgG quantitation is an accurate and swift cell screening method for CLD labs.

The Beckman Coulter Life Sciences Valita Titer microplates facilitate rapid IgG quantitation, producing results within 15 minutes. By simplifying liquid handling and offering the opportunity to automate several aspects of IgG quantitation, Valita Titer microplates also reduce hands-on time, further reducing turnaround time.

The analytical laboratory can then address bottlenecks in mAb characterization by embracing streamlined workflows to accelerate the analysis process and generate more comprehensive data to enable more informed decision-making.

Platforms such as SCIEX Intabio ZT System offer streamlined workflows for intact protein analysis, charge variant analysis, and post-translational modification characterization, accelerating clone selection. Combining automated imaged capillary isoelectric focusing sample preparation with high-resolution mass spectrometry, the Intabio ZT system reduces the time to identify promising candidates from weeks to minutes.

Overcoming analytical bottlenecks in CLD is crucial when developing monoclonal antibodies. With the appropriate tools and expertise, you can ensure consistent and swift time to market. Contact an expert at the Life Sciences companies of Danaher today to explore solutions tailored to your needs.