Biologics GxP Applications

  • The systems include Octet CFR software and ForteBio’s FB server features for secure and traceable electronic record keeping
  • Optional IQ/OQ/PQ packages ensure that Octet systems are qualified and operate as intended
  • Support services in software and biosensor validation are provided



Octet solutions for lot release

Overview for Biologics GxP Applications

Regulatory requirements necessitate that biologics drug products be QC tested using methods that are robust and have been appropriately developed, qualified, and validated under GMP conditions. Among these assays, titer measurement for potency assessment and ligand binding kinetics assays are increasingly being used for biological products' lot release. Drug developers are constantly in search of analytical technologies with robust features that are easy to use and adaptable in QC and manufacturing.

  • Ligand binding potency assays on the Octet platform

    Reproducible and accurate relative ligand binding potency methods can be developed using analytical technologies. These methods can be used to asses lot-to-lot variability by monitoring either the kinetics of binding or by comparing affinity constants. They can also be used to determine the stability of the different lots of the drug, hence the method has to indicate stability. Due to their ease of use and fast time to results, real-time label-free analytical techniques are increasingly becoming attractive for the development of methods for assessing the potency of drug candidates.

    • Readily accommodates the use of DOEs to rapidly develop robust potency measurement methods
    • Develops relative affinity constant or response signals comparability studies for potency measurements

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    Fc receptor binding assays on the Octet system

    The safety and efficacy of a therapeutic monoclonal antibody can be greatly impacted by its ability to bind to both the target and to the FcγR. Antibodies are often selected based on their binding properties to FcγRs. They are sometimes engineered to achieve desired FcγRs binding properties. As a result, the assessment of binding affinities of these antibodies to FcγRs is an integral part of biotherapeutic development processes.

    • Octet systems offer high throughput and sensitive methods for Fc receptor binding analysis
    • A variety of biosensor surfaces are available and allow for flexibility and rapid optimization of assay format

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  • Titer determination on the Octet platform

    Titer and protein concentration determination is a critical process in the development of biologics drug molecules. The active protein concentration can be used to determine the potency of the drug molecule. While ELISA and especially HPLC are commonplace techniques for titer and protein concentration determination, techniques that are more robust to cell culture and media are especially desirable as they can be easily adopted in both upstream and downstream processes during the development of the drug molecule.

    • A full plate (96 samples) of IgG titer can be analyzed in as little as two minutes
    • Sample plate format allows for the use of crude and non-purified samples
    • Automation capable Octet HTX and Red 384 allow for walkaway high throughput analysis

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Resources for Biologics GxP Applications

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