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 correction 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 necessary technical administrative features for compliance with FDA regulations. A Software Validation Package that verifies calculations is available.
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 Assays
For analysis of assays including ligand/target binding, kinetic screening, kinetic analysis of protein-protein, protein-small molecules, antibody-antigen, antibody-VLP, antibody-Fc gamma receptors and antibody-neonatal receptor (FcRn) interactions. Lot release and stability testing of drug molecules can also be analyzed using Octet® BLI software.
Additional features allow users to combine and analyze multiple experiments and plates together and employ flexible reference sample and biosensor subtraction. Advanced data processing options can remove bulk shifts or assay artifacts. Faster and improved 1:1, 1:2, 2:1 and mass transport curve fitting models along with Local (partial or full) or Global data fitting options. Customize and export final reports in Excel and PDF.
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.
Epitope Binning Assays - Advanced Analysis with Octet® Analysis Studio
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 displaying antibody clusters. 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.
Specifications
Processor | 3.0 GHz Quad Core processor or greater |
Operating system | Windows 7 Professional or Windows 10 Professional, 64-bit. Older Octet® instruments are also compatible with Windows 7 Professional 32-bit. 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 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 |
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Resources and applications on Octet Systems Software
- Octet CFR Software V12.X and Software Validation Package Datasheet PDF | 197.7 KB
- Cross-Competition or Epitope Binning Assays on the Octet® RH96 System PDF | 4.1 MB
- Enhanced Productivity and Labor Efficiency in Lot Release and In-Process Testing of Biologics in GxP Laboratories PDF | 924.3 KB
- Octet® Kinetics Assay Method Development Guideline
