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.
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
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
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.
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 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 antibodiesRead 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
Flyer 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
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 therapeuticsRead 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