Octet GXP Wheel

Applications

ForteBio GxP Offering

Octet Systems

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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.

Installation and Operational Qualification Kit and Services

Proteins can be assayed in crude mixtures such as cell lysates or hybridoma supernatants, glycerol, or in up to 10% DMSO, which drastically reduces sample preparation

Crude Sample Compatibility

Octet systems provide definitive analysis of kinetic binding constants at a fraction of the price of traditional SPR systems

High Quality Data at an Affordable Price

Higher Throughput

Our proprietary Bio-Layer Interferometry (BLI) technology monitors the binding of proteins and other biomolecules to their partners directly in real time.

Label-Free, Real-Time Results

Is an Octet system the right fit for your lab?

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Octet systems accelerate every stage of biotherapeutic drug discovery and development by delivering results rapidly for a large number of assay types. 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.

Confident Compliance

Explore the hotspots

Enables large molecule characterization as well as small molecule and fragment analysis. The system supports two 384- or 96-well microplates, provides 16-well simultaneous read-out, biosensor re-racking and automation compatibilities.

Octet RED384 System

IQOQ and Performance Certification

21 CFR Part-11 Software and Validation

Performance Qualification for Quantitation and Kinetics

Service and Technical Support

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Octet systems perform sample analysis in 96- and 384-well microplates, processing up to 96 samples in parallel. Protein quantitation of 96 samples can be completed in as little as two minutes — a task that can take from 4 hours to overnight using traditional ELISA. Rapid kinetics, screening and epitope binning assays are enabled by the multiplexed biosensor formats.

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Performance Qualification Kits

ForteBio PQ Kits provide rapid and convenient methods to verify performance of your Octet RED96e instrument. 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

Using software that complies with 21 CFR Part 11 guidelines and validating the software are regulatory requirements prior to using any analytical instruments in a GxP environment. Octet CFR software includes features such as controlled user access, comprehensive audit trails, customized locked reports and electronic signatures. All data acquired by Octet CFR software is digitally signed to protect data integrity. 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.

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Biosensor Validation Service

This service enables 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.

Confident GMP Compliance - Applications

Enables large and small molecule analysis for low throughput users. The 2-channel system supports one 96-well plate with biosensor re-racking.

Octet K2 System

Measurement of Active Concentration Assays

The Octet platform provides a convenient and reliable analytical method for measuring antibody and active recombinant protein concentrations.

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.

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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Enables the highest throughput large molecule characterization as well as small molecule and fragment analysis. The system supports two 384- or 96-well microplates and provides up to 96-well simultaneous read-out, biosensor re-racking and automation compatibilities.

Octet HTX System

Enables large molecule characterization. The system supports one 96-well plate, provides 8-well simultaneous read-out and biosensor re-racking.

Octet QKe System

Enables large molecule characterization and small molecule and fragment analysis. The system supports one 96-well plate, provides 8-well simultaneous read-out and biosensor re-racking. Enables assays to be performed over a wider temperature range of 15-40C and longer experimental time up to 12 hours with evaporation control.

Octet RED96e System

Is your current method not fast enough?

The Octet HTX enables direct quantitation of 96 samples in 2 minutes, and kinetics in a fraction of the time compared to traditional SPR.

Your Current Challenges

Can't keep up with the number of samples?

Ready-to-use biosensors and detection kits including kits for impurity testing are available, reducing hands-on time compared to ELISA. Further maximize your unattended run time by integrating one of our custom automation bundles in your workflow.

New to Validation?

Establish hardware and method validation standards to ensure an analytical method is suitable for its intended purpose. This provides an assurance of reliability for routine testing in GMP environment. Validation involves comprehensive protocol-driven experiments that evaluate and document the performance of an assay.

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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. In addition, Octet systems have become a solution platform for potency analysis of drug-target and drug-Fc receptor(s) (FcyRI, FcyRIIa, FcRIII, and FcRn) interactions. Moreover, Octet instruments are suitable for stability analysis that assess changes in activity in stressed and forced degradation assays. The high-throughput capability and flexibility of the platform enables rapid completion of assay method development through design of experiments (DOE) essential in identifying and controlling critical quality attributes (CQAs) that ensure consistent and reliable quality of biopharmaceutical products.

The Octet platform provides a convenient and reliable analytical method for measuring antibody and active recombinant protein concentrations. The simple Dip and Read™ approach enables streamlined workflows and rapid quantitation of as many as 96 samples in as little as 5 minutes on the Octet HTX system or 80 samples in < 30 minutes on the Octet RED96e system. Samples can be analyzed in cell culture supernatant or in complex media, thus removing the need for purification.

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 techniques.

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ForteBio GxP Offering

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