ForteBio is now part of the Sartorius group. Click here for more

GxP Compliance Tools

Comprehensive tools for GxP compliance combined with extreme simplicity of operation enable application of Octet systems in analytical development and regulated quality control (QC) labs.

From antibody quantitation, ligand binding to potency assays, the GxP compliance tools offer Octet users confidence in developing validated assay methods

ForteBio’s 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.

GxpConfident 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 ForteBio’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

    ForteBio 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.

Active Antibody/Protein Concentration Determination

Active Antibody/Protein Concentration Determination

Despite its widespread adoption, variability in results, susceptibility to human error, labor intensive workflow, and slow times-to-result remain as big hurdles for users looking to adopt ELISA in high throughput applications. GxP compliant Octet systems are aptly designed to solve these problems. ELISA assays can be directly transferred onto validated methods for confident concentration determination on Octet systems.

Ligand binding and Potency Assays

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. ForteBio offers ready-to-use biosensors for the immobilization of a variety of ligands including Fcgamma 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.

Protien Contaminant Testing

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 (designed with sensitivity in mind) provide biologics developers with a rapid and easy to use technique for contaminant testing.

Stability & Forced Degradation Studies

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.

Resources of GxP Compliance Tools

Application Note Analysis of Fc-gamma Receptor-IgG Interactions on the Octet Platform

Fc gamma receptors (FcγRs) are membrane glycoproteins with affinity for the Fc region of immunoglobulin G (IgG). FcγRs expressed on the surface of immune effector cells play a key role in initiating Fc effector functions such as antibody-mediated cell-dependent cytotoxicity (ADCC)1, which is a major mechanism of action of therapeutic monoclonal antibodies

Read more

Application Note Customized quantitation of recombinant therapeutic proteins using High Precision Streptavidin biosensors (SAX)

The accurate determination of recombinant protein titer is critical to the selection of high-producing clones during cell line development and in optimization of bioreactor conditions during production of therapeutic proteins.

Read more

Application Note Octet Potency Assay: Development, Qualification and Validation Strategies

Kinetic analysis of biomolecular interactions is critical during drug discovery and development. The affinity of an interaction directly affects the dose required for a biopharmaceutical to be effective.

Read more

Technical Guide CHO Host Cell Protein Detection

Host cell proteins (HCPs) are contaminants found in biopharmaceuticals expressed in bacterial, yeast or mammalian production cell lines. Among protein expression cell lines, Chinese hamster ovary (CHO) cells are the most commonly used mammalian hosts for industrial production of recombinant protein therapeutics

Read more

White Paper Octet platform: a complete solution for lot release and in-process testing of biologics in GxP laboratories

Bio-Layer Interferometry (BLI) is an optical analytical technique that analyzes the interference pattern of white light reflected from two surfaces: a layer of immobilized protein on the biosensor tip and an internal reference layer (Figure 1A). Any change in the number of molecules bound to the biosensor tip causes a shift in the interference pattern that can be measured in real time (Figure 1A and 1B).

Read more

Application Overview Octet Systems: Modernize biopharmaceutical QC testing to increase efficiency

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

Read more

Application Overview 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 drug products, vaccines, or diagnostic reagents.

Read more

We use cookies to personalize content and improve your browsing experience.

We also use analytics & advertising services. To opt-out click for more information.