GxP Compliance

GxP Compliance Tools

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GxP Compliance Tools for Octet Systems

From Antibody Quantitation, Ligand Binding to Potency Assays, the GxP Compliance Tools Offer Octet Users Confidence in Developing Validated Assay Methods

  • Comprehensive tools for GxP compliance
  • Extreme simplicity of operations in analytical development and regulated quality control labs

A comprehensive tool set for compliance makes the Octet system an ideal analytical instrument in regulated quality control (QC) labs for lot release and in-process testing for ligand binding, concentration, and impurity analysis in both upstream and downstream processes.

Sartorius Solutions for GxP Compliance

Compliant Installation and Operational Qualification (IQOQ) Kit and Services

The IQ/OQ kit provides comprehensive documentation to verify the Octet instrument, accessories and computer system are supplied and installed per Sartorius's guidelines by certified personnel. It also provides documented verification that the Octet instrument operates as intended at the user site by inspecting the critical components. These tests verify that the various key operational parameters, such as the optical system, plate temperature, system alignment, lamp performance, and shaker speed meet stipulated specifications.

Performance Qualification Kits

PQ kits provide rapid and convenient methods to verify performance of your Octet RED96e System. PQ can be performed using one or both of two tightly controlled assays, depending on the intended use of the instrument. The PQ-Kinetics and quantitation assays verify accuracy and precision of the assays are within specifications for a well characterized model system pair.

Octet CFR Software and Software Validation Package

For researchers working in GLP or GMP laboratories, the Octet Software Validation Package provides the most comprehensive documentation and tools available to validate the ForteBio FB Server Monitor and Octet CFR Software features and functions. It trims validation time to just three days using a fully-integrated manual that mirrors the validation process in a regulated laboratory and by providing sample data sets to authenticate analysis within Octet software to traditional programs including Microsoft® Excel®, and GraphPad Prism.

Biosensor Validation Service

This service enables the Octet system users to sample multiple lots of a biosensor during assay qualification and validation, and reserve a well-characterized lot for purchase. The service is available for the following biosensor types: Protein A (ProA), Streptavidin (SA), High Precision Streptavidin (SAX), Ni-NTA (NTA) and Anti-Mouse Capture (AMC). Customers can order up to five different biosensor lots, up to 20 trays from each lot for evaluation, and reserve up to 40 additional trays for future purchase.

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Applications

Active Antibody/Protein Concentration Determination

ELISA assays can be directly transferred to validated methods for confident concentration determination on Octet systems.  Octet assays reduce the variability, labor-intensive workflow, and slow times-to-result of traditional ELISAs.

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Ligand Binding and Potency Assays

Octet instruments are increasingly being used for the development of analytical methods for ligand binding to target and potency assays for batch lot release.

Sartorius offers ready-to-use biosensors for the immobilization of a variety of ligands including Fc-gamma receptors for affinity measurements to target and for potency assays. Octet systems are especially suitable for these assays as they decrease method development time significantly compared to SPR and ELISA.

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protein contaminant diagram

Protein Contaminant Testing

Protein contaminants are a major hurdle to overcome during the production of biopharmaceuticals. The Octet platform's rapid high throughput protein analysis combined with the anti-CHO HCP and Residual Protein A kits  provide biologics developers with a rapid and easy to use technique for contaminant testing.

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Stability & Forced Degradation Studies

Stability indication is a key requirement by regulatory bodies for analytical procedures used for monitoring stability and activity of drug molecules. Octet platforms can also be used to rapidly develop stability-indicating methods, and are suitable for measuring and distinguishing between fully-functional drug products and those whose binding activities have been affected by degradation.

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Featured Publications

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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Octet Potency Assay Development Qualification and Validation...

Real-time data on affinity and the kinetics of binding can provide useful information at every stage of biopharmaceutical reagent development.

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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 Kinetics Assay Method Development Guideline

Aimed at developing kinetics binding assays to establish specificity, accuracy, precision, linearity and range as stipulated by the USP 1032...

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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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