22 June 2023 | Thursday | Analysis
But developing a bispecific antibody presents several challenges, including those related to dual binding, screening, pharmacodynamics, tissue tropism, and potency. The following are key considerations:
A critical component of the bispecific antibody development workflow is to ensure appropriate cell line development protocols are in place. Recently, cell line development workflows have been enhanced by automation and high-throughput technologies for clone development, clone selection, cell expansion, and cell growth analysis. But despite these advancements, challenges remain in higher-throughput bioanalytical assay development to evaluate clone productivity and characterize the protein product.
Affinity high-performance liquid chromatography (HPLC) and size exclusion (SEC) HPLC is often used to characterize protein expression from cell lines. However, each involves lengthy, complex workflows, resulting in longer process time to data and subsequent analysis. Common bottlenecks include:
Addressing these challenges is critical for the successful development of bispecific antibodies.
Improving speed, efficiency, and productivity
The advent of next-generation and higher-throughout protein analysis and characterization platforms provides a time-efficient and effective method for evaluating bispecific antibody protein quality, offering significant time savings compared to traditional methods such as affinity or SEC HPLC. By improving speed, efficiency, and productivity of bispecific antibodies, labs can accelerate their antibody development projects and reduce common bottlenecks.
The LabChip® GXII Touch™ protein characterization system can be used for bispecific antibody evaluation, specifically to analyze titer, protein degradation, protein aggregation, glycan profiling, and potency determination as part of the cell line development workflow.
As more bispecific antibodies are produced for therapeutic applications, fast and accurate methods for evaluating and characterizing the stability of these antibody drugs are needed. As demonstrated in this application note, high-throughput HTRF® and LabChip GXII Touch platforms can provide complementary insights into stability and the degradation pathways of a bispecific antibody. By leveraging the biochemical HTRF binding assay, the functionality of the antibody can be assessed, allowing for stability evaluations across various formulations. The LabChip ProteinEXact assay offers valuable insights into the degradation of specific antibody components, such as the light chain or the heavy chain. These complementary platforms serve as crucial tools in evaluating the stability and variability of bispecific antibodies, making them indispensable in the biologics workflow for assessing their identity and robustness as potential biotherapeutics.
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