Utilizing Octet Platform for Characterizing Critical Reagents in Support of Drug Development for Contemporary Biotherapeutics
Today, biotherapeutic drugs comprise a large portion of new drug candidates in Biopharma industry portfolios. In addition to the dramatic growth in the numbers of large molecule drugs, there is much increased diversity and structural complexity, including multi-domain therapeutics, non-proteins, new treatment modalities and advances in delivery systems. Furthermore, at present there is an immense effort underway to create new novel vaccines as treatments to remedy the COVID-19 pandemic. This shift to emphasis to large molecule therapeutics has generated renewed awareness for the need for innovation in the design, generation, characterization, and life cycle management of Critical Reagents to support both product development and regulated bioanalysis. This scenario requires critical reagent workflows that are easily customized, executed efficiently, versatile, have high throughput and operationally reliable. Accordingly, we have adapted the label-free optical technique of Bio-Layer Interferometry (BLI), the Octet© platform provides real time analysis of biomolecular interactions as key tool in our critical reagent workflow. Accordingly, here we present two case studies utilizing Octet® BLI technology for critical reagent characterization. The first study summarizes application of BLI technology combined with ELISA to investigate lot-to-lot batch differences for antibody critical reagent developed against a biologically active toxin. The second one describes the combination of ion-exchange chromatographic analysis with the Octet® BLI platform to separate and analyze the receptor-binding activity of various charge variants for a fusion-protein drug substance. These two case studies exemplify the benefits from broad application of BLI in our standard workflows for characterization of custom critical reagents for modern biotherapeutics. We conclude to that use of Octet® HTX (now Octet RH96) instrument is particularly beneficial, because it has afforded much increased efficiency to our operation due to increased capacity and speed.
Ronald R. Bowsher, Ph.D., FAAPS
B2S Life Sciences
Erica Simmons, Ph.D.
B2S Life Sciences
- Understand how Octet® BLI technology for affinity characterization antibodies can benefit critical reagent workflows, such as guiding decision-making about assay sensitivity and lot to lot comparisons
- Benefits of mixed use of ELISA and BLI to support critical reagent comparison studies
- Using Octet® BLI technology for quality control and batch release of drug-substance