Octet Systems Software

Octet CFR software and our GxP Server enable data acquisition and data analysis in laboratories working under GMP, GLP, and 21 CFR Part 11 regulations. It also provides all necessary technical administrative features for compliance with FDA regulations. A Software Validation Package that verifies calculations is available.

User friendly software for data acquisition and analysis; enables easy method development and data analysis

From kinetics and quantitation analysis of antibodies, proteins, protein residual contaminants and other biological molecules, Octet software is intuitive and easy to use.

Octet Systems SoftwareOctet Systems Software
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    Design and analyze an assay in minutes

    A new assay can be set up in just a few minutes. To make assay setup even faster, experimental method templates are available. Analysis settings can be saved and applied to a new assay to significantly speed up routine analysis.

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    Compliance

    Octet CFR Software and our GxP Server enable data acquisition and data analysis in laboratories working under GMP, GLP, and 21 CFR Part 11 regulations. It also provides all necessary technical administrative features for compliance with FDA regulations. Controlled access with multiple user levels and a set of permission structure are available: administrator, developer, supervisor, lab user.

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    Customized report generation

    Create customized reports for experiments, combining various data elements such as graphs, text, data tables, company logo, images and experimental details. Reports are ready to be uploaded to an electronic notebook or stored in the database. Report templates can be saved and reloaded to make similar reports for additional datasets.

  • Analysis of multiple sample plates

    Software allows for the analysis of multiple sample plates and experiments together in Octet Data Analysis HT software, reducing analysis time from hours to minutes.

  • Data processing flexibility; customizable PDF data reports

    More flexible and advanced data processing and correction options to choose from. PDF data reports can be customized using text, graphs, data tables and images.

  • Automated analysis

    Automated analysis is enabled for quantitation, kinetic, and epitope binning data.

  • 21 CFR Part 11 compliance - electronic signatures

    Primary data integrity is secured through electronic signatures—acquired data is digitally signed and is invalidated if tampered with.

  • 21 CFR Part 11 compliance - enhanced audit trail

    All actions are recorded and time-stamped with details of old vs. new values.

Epitope Binning Assays

 

Epitope Binning Assays

 

Example: BinChart from a 32x64 screen. Each bin represents antibodies that block each other's ability to bind the antigen, and have similar blocking profiles when paired with other antibodies in the panel.

Epitope Binning Assays - Advanced Analysis with HT Software

Append and overlay data from multiple experiments, plates or biosensor trays to create a combined dataset for advanced analyses. Software automatically finds the binning cycle pattern and creates a 2-D traffic-light matrix and BinChart for you. Cluster antibodies in similar bins or groups using custom (Euclidean, Pearson, Maximum) algorithms. Additional matrix analyses like normalizing to controls or self-binding and highlighting unidirectional binning pairs can be performed. Simple data quality assessment can be accomplished by monitoring loading levels and flagging antibodies with high off-rates. Customize and export final reports in Excel and PDF.

Kinetics Assays

Kinetics Assays

Applications: Ligand/target binding, kinetic screening (off-rate or affinity) in supernatants and purified samples, kinetic analysis of protein-protein, protein-small molecules, antibody-antigen, antibody-VLP, antibody-Fc gamma receptors, antibody-neonatal receptor (FcRn) interactions. Lot release and stability testing of drug molecules can also be analyzed using Octet software.

Combine and analyze multiple experiments and plates together. Flexible and additional reference sample and biosensor subtraction Advanced data processing options remove bulk shifts or assay artifacts Faster and improved 1:1, 1:2, 2:1 and mass transport curve fitting models Local (partial or full) or Global data fitting options Steady-state analysis Add report point(s) to any step in the sensor trace for screening purposes Customize and export final reports in Excel and PDF.

Quantitation Assays

 

Quantitation Assays

 

In Octet Data Analysis HT software version 12, fitted traces can now be overlaid on raw binding traces for optimal visualization. The Best Fit model classifier was used in this example.

Quantitation Assays

Quantitation of total IgG, Fab and custom proteins, contaminant testing such as host cell protein (HCP) and residual protein A, pharmacokinetic (PK) assays, antibody isotyping in complex samples, glycosylation profiling, vaccine titer determination etc. Combine and analyze multiple experiments and plates together. Multiple and flexible reference subtraction Linear, 4 and 5-parameter logistic (PL) unweighted and weighted fittings. View and analyze any step(s) in a multi-step ELISA-type assay. Automated sample alert tools to evaluate data quality for precision, accuracy and dilution linearity, enabling you to interpret results with confidence.

Import previously made standard curves for routine assays Customize and export final reports in Microsoft® Excel® and PDF formats.

Processor

3.0 GHz Quad Core processor or greater

Operating system

Windows 7 Professional or Windows 10 Professional, 64bit.
Older Octet instruments are also compatible with Windows 7 Professional 32bits. Contact a Fortebio representative to learn more

Data connection

3 available USB 2.0 ports
Octet control features do not support USB 3.0
1 available RS-232 serial port - Two serial ports are required in some older Octet models, contact a Fortebio representative to learn more

Memory

4 GB RAM or greater

Graphics display

Static or 100–1500 rpm

Software installation and activation

A DVD or CD drive is required to install the Data Acquisition and Analysis software

Hard Disk

250 GB hard drive or greater 200 MB available hard disk space required for application files more to acquire data – a single experiment can range from 1 MB to over 100 MB

Additional Software

Microsoft Office

Helpful Tips

• Laptops are not recommended for use with Data Acquisition
• A DVD or CD drive is required to install the Data Acquisition and Analysis software
• Computer workstations that are not supplied by ForteBio are not covered under the Octet warranty or service contracts.

Resources of Octet Systems Software

Application Note Cross-competition or Epitope Binning Assays on the Octet HTX System

Epitope binning is a term used to describe segmentation of a panel of monoclonal antibodies (mAbs) into “bins” based upon the antigen region, or epitope, bound by each antibody.

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Data Sheet Octet CFR Software and Software Validation Package

Recent enhancements to our Octet CFR Software and Software Validation Package Server Monitor Module, along with software validation package support enable all Octet® instruments to be integrated seamlessly into GxP regulated environments.

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Data Sheet Octet software comparison

ForteBio Octet Data Acquisition and Data Analysis software is rapidly evolving to better address the growing applications and needs of our customers. These comparison tables provide a general guide to the features included in various versions of the software. The latest release, Version 11, is available for use on all Octet systems. For more information or for upgrade options, please contact your local sales representative or fill out our software download request form.

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Data Sheet Octet Data Analysis HT Software

The Octet® Data Analysis HT software is designed for fast analysis of large datasets from quantitation, kinetic and epitope binning assays.

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Technical Guide Octet kinetics assay: method development guideline

The purpose of this document is to describe the procedure for developing a ligand binding kinetics assay on Octet® QKe, RED96, RED96e, RED384 and HTX instruments. The procedures described are for developing binding kinetics assays for release testing of product batches and related applications. The document is intended as a general guideline only. Actual method development procedures may be different as they may be product dependent.

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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).

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