Accelerating the Development and Manufacture of Therapeutics Using the Octet^® Platform

The high costs of therapeutic discovery, development, and manufacture require improved process efficiencies and economics. Analytical tools that eliminate the need for reagent labeling and enable real-time data visualization save development time and improve efficiencies during process development. The Octet^® biolayer interferometry (BLI) platform and assays can be used throughout process development and manufacturing, including cell-line development, clone selection, and dynamic binding capacity (DBC) determination for affinity purification columns. The ability of the Octet^® BLI platform to monitor binding interactions in real time, coupled with its capability to analyze samples in their crude matrix and in high throughput, can help shorten development and analysis times, leading to significant cost savings and dramatically improved process economy.

Topics discussed include:

• Principles of Bio-Layer Interferometry
• Advantages Over ELISA and HPLC
• Upstream Bioprocessing Applications
  • Concentration Measurement
  • Titer Determination and Clone Selection
  • Cell-Line Development
• Downstream Bioprocessing Applications
  • Dynamic Binding Capacity (DBC) Determination
  • Residual Contaminant Detection
  • Formulation development
  • Quality Control (QC)
  • Potency Determination
  • Stability Studies
• Viral Vector Bioprocessing Applications
• Vaccine Bioprocessing Applications
  • SARS-CoV-2 Vaccine and Therapeutics Development
  • Influenza Vaccine Potency Assay
  • Nanoparticle Vaccine Constructs
• Dengue Vaccine Avidity Assay