Biologics GxP Applications

Label-Free Assays for Process Development and QC

Biologics drug products must be QC tested using methods that are robust and are appropriately qualified and validated under GMP conditions. The Octet platform facilitates method development for in-process and lot release testing that can be easily transferred to QC.  The ease of use and high throughput capacity of the Octet systems allow for enhanced productivity of up to 40X over ELISA and up to 16X over select SPR instruments for certain applications.

Octet systems come ready for GMP implementation with:

  • Octet CFR software and server applications for secure and traceable electronic record keeping
  • Optional IQ/OQ/PQ packages to qualify instruments are installed, operating, and performing as intended
  • Support services and biosensor validation


Fc Receptor Binding Assays diagram

Fc Receptor Binding Assays

The safety and efficacy of a therapeutic monoclonal antibody can be greatly impacted by its binding to both the target and to the FcγR. Antibodies are often engineered to achieve desired properties including binding to FcγRs.

Octet systems offer high throughput and sensitive methods for Fc receptor binding analysis, with a variety of biosensor surfaces available for rapid and flexible assay development.

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Ligand Binding Potency Assays diagram

Ligand Binding Potency Assays

Reproducible and accurate relative ligand binding potency methods can be used to assess lot-to-lot variability by monitoring either the drug binding response or the kinetics of binding including affinity constants. An ideal method must be stability-indicating as well.

The Octet platform is increasingly used for assessing the potency of drug candidates.  Octet systems:

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

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Titer and Protein Quantitation graph

Titer Determination

The active protein concentration can be used to determine the potency of the drug molecule.  Octet instruments can be used to develop methods that measure only the active protein. Traditional protein concentration determination techniques, like HPLC are being supplanted by more robust Octet assays in both upstream and downstream bioprocesses.  With Octets:

  • Measure directly in crude and unpurified samples, like cell culter media
  • Obtain IgG titer for a full microplate of 96 samples of in as little as two minutes
  • Walk away with automation capable Octet HTX and Red384 systems

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Analysis of Fc Gamma Receptor IgG Interactions on Octet Platform

Whether you're assessing FcRn-Antibody or FcγR-IgG binding interactions, you need a high throughput, versatile, and easy to use solution.

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Analysis of FcRn-Antibody Interactions on Octet Platform

Assay design recommendations and best practices for producing the highest quality of kinetic data.

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Customized Quantitation of Recombinant Therapeutic Proteins

Using High Precision Streptavidin Biosensors (SAX)

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Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control

Validated Quantitation and Activity Assay of Fab Molecule for...

The group was able to develop a working Fab activity assay on the Octet RED system in less than a week. Relative to the overnight incubation and...

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Enhanced Efficiency in Lot Release and In-Process Testing of Biologics cover

Enhanced Efficiency in Lot Release and In-Process Testing of Biologics

Bio-Layer Interferometry (BLI) is an optical technique that analyzes the interference pattern of white light reflected from two surfaces: a layer...

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Octet® Systems: Modernize Biopharmaceutical QC Testing to Increase Efficiency

Modernize Biopharmaceutical Quality Control Testing

Quality control of biological products to support clinical trials and post market assay activities require the evaluation of multiple critical...

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High productivity and process economy in GxP applications with Octet

Quantitation assays must show precision, accuracy, linearity, and reproducibility. To be used for GMP applications, they must be developed with...

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Converting ELISA Assay into Octet Quantitation Assay

Quantitation assays on the Octet® platform have many similarities to enzyme-linked immunosorbent assays (ELISA). Both are performed on a solid...

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Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics cover

Enhancing Efficiency and Economics in Process Development and...

Analytical techniques that measure protein quantity and quality are used in nearly all stages of research, process development and manufacturing...

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Octet Potency Assay: Development, Qualification and Validation...

In this application note, we discuss the strategies for the development and validation of a potency assay using Octet® systems. We have...

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Enhanced Efficiency in Lot Release and In-Process Testing of Biologics cover

Octet platform: a complete solution for lot release and...

Bio-Layer Interferometry (BLI) is an optical analytical technique that analyzes the interference pattern of white light reflected from two...

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Quality control of biotherapeutics using Octet systems

Bio-Layer Interferometry (BLI) has been rapidly adopted as an important analytical tool in laboratories that work with biological molecules...

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Octet HTX

96-Channel Ultra High Throughput Octet System: Octet HTX

Monitors up to 96 biosensors simultaneously, enabling label-free detection for protein quantitation and kinetic characterization at unmatched speed

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Octet RED384

16-Channel High Throughput Octet System: Octet RED384

The Octet RED384 16-channel instrument provides analytical performance similar to the 8- channel Octet RED96 system, but with higher levels of...

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Octet RED96e

8-Channel Octet System: Octet RED96e

The 8-channel Octet systems perform quantitation of 96 samples in 32 minutes and kinetic screening of 64 samples in 1.5 hours.

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Octet QKe

8-Channel Octet System: Octet QKe

Unmatched versatility for discovery, development, and quality control

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