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Efficient Discovery, Development and QC of Antibodies - The Path to Progress Just Got Simpler

Efficient Discovery, Development and QC of Antibodies - The Path to Progress Just Got Simpler

There is a considerable need, in the industry, for techniques that enable greater accuracy in the identification of lead molecules. In addition to accuracy in identifying functionally specific molecules, achieving the necessary throughput to support screening needs is another major challenge in early discovery and during process development. Technologies that can accurately identify the right targets and deliver the throughput necessary for screening large panels, would significantly reduce the time to the discovery and ultimately help lower costs.

Bio-Layer Interferometry (BLI) is especially versatile in the screening of biologics during discovery, cell line development and bioprocessing. BLI is a practical and effective technique for monitoring antibody-antigen interactions, with binding events monitored label-free and in real-time. The adoption of BLI has rapidly increased over the past two decades, and the technology has gained widespread acceptance in the biopharmaceutical industry.

Octet® systems provide antibody discovery scientists with a single solution for monitoring antibody-antigen interactions in the selection of lead molecules and determining titer in high-throughput. The systems provide robust label-free analysis of crude samples to assess biomolecular interactions, like kinetic rate constants, affinity binding constants, and specific molecule quantitation. High-throughput screening of up to 96 samples in parallel allow for early selection of engineered molecules and optimization of their production. Engineered biologics include monoclonal antibodies, bispecific antibodies or antibody-drug conjugates.

The instruments do not contain microfluidics components, thereby significantly reducing assay complexity.  This eliminates individual sample loading times, omits time-consuming cleaning steps and reduces other all operating costs.  Relatively easy-to-develop methods combining detection in a sample plate format and crude sample tolerance allows for rapid assay optimization that accelerates the selection of optimal, high-quality antibodies earlier in the drug discovery process. Furthermore, the measurement is non-destructive and the samples, especially in the development process, are available for further experimental analysis. BLI applications can also be used in bioprocessing to assess for critical quality attributes including glycan screening, host cell protein analysis and residual protein A detection, among others.

Benefits of the BLI technology:

  • Fluidics-free industry standard for label-free analysis 
  • High-quality protein kinetics and quantitation in real-time
  • Flexibility of sample type including crude matrices such as cell lysates or culture supernatants
  • Maximum productivity and throughput 
  • One platform, countless assay options
  • Wide fit across biologics development and manufacturing
  • Unmatched cost-effectiveness
  • Responsive and customized scientific support
  • Reliable global service and supply chain

High-throughput capability and assay versatility enable rapid development and qualification of test methods for monitoring critical quality attributes of biopharmaceutical products. For regulated environments, Sartorius offers a comprehensive GxP portfolio of products and services to help you to meet compliance requirements.

The GxP package includes:

  • Installation and operational qualification (IQ/OQ) kit and services
  • Performance qualification (PQ) kits 
  • Octet® CFR software
  • Software validation package support
  • Biosensor validation service

Above all Sartorius is a leading international partner of the biopharmaceutical industry and the research sector providing a reliable supply chain and a global service team. Build on a responsive and customized scientific support to lead your development project to success. The path just got simpler.

About Sartorius
Sartorius' ambition is to simplify medical progress, from the first idea of a new medication to its production. They support their customers with innovative technologies that make the development and manufacture of new therapeutics faster and more efficient, so that more people have access to better medicine.
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