Data Acquisition and Analysis Made Simple
Enable Easy Method Development
- Analysis of multiple sample plates - Software allows for analysis of multiple sample plates and experiments together in Octet® Analysis Studio, reducing analysis time from hours to minutes.
- Data processing flexibility and customizable PDF data reports - More flexible, advanced data processing and referencing options to choose from. PDF data reports can be customized using text, graphs, data tables and images.
- Automated analysis - Automated analysis enabled for quantitation, kinetic and epitope binning data.
- 21 CFR Part 11 compliance and 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 with enhanced audit trail - All actions are recorded and time-stamped with details of old vs. new values.
Octet® CFR software and our Octet® GxP Server enable data acquisition and data analysis in laboratories working under GMP, GLP and 21 CFR Part 11 regulations. They also provide necessary technical administrative features for compliance with FDA regulations. An additional Software Validation Package is available to validate data calculations produced by the Octet® software.
Benefits of Octet® Analysis Studio
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 new assays to speed up routine analysis.
Octet® CFR Software and our Octet® GxP Server enable data acquisition and data analysis in laboratories working under GMP, GLP and 21 CFR Part 11 regulations. They also provide 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.
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.
Applications
Kinetics and Affinity Analysis
Octet® Analysis Studio allows for fast and convenient analysis of assays measuring kinetics and affinity values for drug-target binding and high-throughput kinetic screening for lead identification. Typical applications include kinetic analysis of protein-protein, protein-small molecules, antibody-antigen, antibody-VLP, antibody-Fc gamma receptors, including antibody-neonatal receptor (FcRn) interactions. Additional applications supported include lot release and stability analysis of drug molecules based on binding kinetics and affinity.
- Combine and analyze multiple experiments spanning different days, runs, and replicates
- Allows for flexible sample referencing and biosensor subtraction schemes
- Advanced data processing options for eliminating bulk shifts or assay artifacts from kinetic datasets
- Improved 1:1, 1:2, 2:1 and mass transport curve fitting algorithms along with Local and Global data fitting options
- Create customized data reports and export to Microsoft® Excel® and PDF
Concentration Analysis
Octet® BLI assays are widely used for concentration or titer analysis of various biomolecules including IgG, Fab, custom proteins, and viruses. Additional quantification applications supported include host cell protein (HCP), residual protein A, pharmacokinetic (PK) assays, and antibody isotyping analysis.
- Combine multiple experiments and analyze data using a single analysis template
- Allows for flexible reference subtraction schemes to incorporate and utilize data from control samples easily
- 4PL, 5PL with unweighted and weighted fitting algorithms for concentration analysis
- Ability to view and analyze any step(s) in a multi-step quantitation assay.
- Automated sample alert tools to evaluate data quality for precision, accuracy, and dilution linearity, enabling you to confidently interpret results.
- Import previously prepared standard curves for routine assays
- Customize and export final reports in Microsoft® Excel® and PDF formats.
Potency Analysis
Drug activity or potency can be measured via an Octet® BLI binding assay. Unlike in ELISA or other endpoint detection technologies, when performing potency assays on an Octet® system, every step of the assay can be monitored in real-time, leading to faster assay development. Automated assay workflows also reduce hands-on times while improving assay precision and reproducibility. Octet® Software versions 13.x and above provide potency analysis tools.
- Conveniently setup EC50 and IC50 experiments with built‑in experimental method templates in Octet® Discovery Software
- 3PL, 4PL, 5PL, linear, and semi-log fitting algorithms
- Monitor biosensor loading responses and flag data traces based on user-defined biosensor loading criteria
- Independent and global dose-response fitting options and similarity assessments to effectively compare against standard and test sample groups
- Create customized data reports for presenting and reporting dose-response data and conclusions
- Eliminate errors in data transfer with a built-in potency analysis module, available in both CFR 21 part 11 and non-CFR software versions
Epitope Binning Assays - Advanced Analysis with Octet® Analysis Studio
Octet® BLI systems are ideally suited to run cross-competition assays, due to the combination of assay speed, the versatility of assay design with the ability to perform in-tandem, sandwich as pre-mix assays, and the use of parallel, independent biosensor formats. Octet® Analysis Studio software provides a dedicated module for convenient epitope binning analysis.
- Append and overlay data from multiple experiments, plates, or biosensor trays to create a combined dataset for advanced analyses
- Software automatically finds and annotates the binning cycle pattern and creates a 2D traffic-light matrix and BinChart for displaying antibody clusters
- Cluster antibodies in similar bins or groups based on Euclidean, Pearson, and Maximum algorithms
- Additional matrix analyses such as 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
Processor | 3.0 GHz Quad Core processor or greater |
Operating system | Windows 10 Professional or Enterprise and Windows 11. Contact a representative to learn more |
Data connection | 3 available USB 2.0 ports |
Memory | 4 GB RAM or greater |
Graphics display | Monitor with 1920x1080 resolution or better |
Software installation and activation | A USB drive is required to install the Version 13 Octet® 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 |
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