Biologics GxP Applications

Label-Free Assays for Process Development and Quality Control (QC)

Biological drug products must be quality control (QC) tested using robust methods that are appropriately qualified and validated under GMP conditions. The Octet® BLI 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 Octet® systems allow for enhanced productivity of up to 40x over enzyme-linked immunosorbent assay (ELISA). 
Octet® BLI systems come ready for good manufacturing practice (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

Featured Applications

Fc Receptor Binding Assays diagram

Fc Receptor Binding Assays

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® BLI systems offer a high throughput and sensitive solution for Fc receptor binding analysis, with a variety of assay-ready 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® BLI platform is increasingly used for assessing the potency of drug candidates. Octet® BLI systems: 

  • Readily accommodate the use of Design of Experiment (DOE) 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 active protein levels. Traditional protein concentration determination techniques like HPLC are being supplanted by more robust Octet® BLI assays in both upstream and downstream bioprocesses. These assays enable: 

  • Measurement directly from crude and unpurified samples, like cell culture media 
  • Obtain IgG titer for a full microplate of 96 samples of in as little as two minutes 
  • Walk away with automation capable with Octet® RH96 and RH16 systems

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Analysis of Fc-Gamma Receptor-IgG Interactions on the Octet® Platform

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 the Octet® Platform

Analysis of FcRn-Antibody Interactions on the 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 Octet® SAX Biosensors

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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 Process...

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 four-...

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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 of i...

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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 product...

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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 techno...

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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 support...

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Enhancing Efficiency and Economics in Process Development and Manufact...

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

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

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

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Octet platform: a complete solution for lot release and in-process tes...

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

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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, either as...

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Octet® BLI rapidly determines recombinant protein concentration as a control parameter in cell line development.

96-Channel Ultra High Throughput Octet System: Octet® RH96

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

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16-Channel High Throughput Octet System: Octet® RH16

Ideal for high-throughput applications that demand high sensitivity and low sample volume requirements

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8-Channel System: Octet® R8

Unmatched Flexibility and Versatility in Protein Analysis

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