Product Datasheet

Octet BLI Discovery andOctet® Analysis Studio Software®

Faster, More Powerful Data Analysis with Version 11.0+----Key Features
Analyze multiple plates and experiments together
Customize PDF data reports using text, graphs, data tables
and images
More flexible and advanced reference subtraction options
and preprocessing tools for kinetic data prior to analysis
Additional data correction options to choose fromNew graphical display options to thicken sensor traces andcustomize axis scale and title options
Automated analysis for quantitation, kinetic, dose-responseanalysis, and epitope binning data
Compatible with 32- and 64-bit versions of Windows® 10and 11

Upgrade Information
Octet® Software provides an intuitive and easy to useinterface for data acquisition and analysis on all Octet®
instruments, enabling label-free kinetic, affinity, epitope
binning, activity, concentration, potency, and screening
applications. To upgrade your software to the latest version,please complete the software download form or contact yourlocal sales representative.

Beginning with Octet® Software version 12.1, the applications have been renamed. The Data
Acquisition Software has been renamed Octet® BLI Discovery. The Data Analysis HT Software
has been renamed Octet® Analysis Studio Software.

Octet® BLI Discovery Software
An Experiment Wizard and built-in protocols guide users
through a step-by-step data acquisition process, facilitating
both assay setup and efficient experimental design. Interactive sample plate maps allow rapid plate definition using
simple click and drag mouse movements, and sample wells,
standard wells, biosensors and regeneration steps aredescriptively color-coded. During acquisition, data are displayed in real time with a detailed graphical interface thatshows experimental progress. Interactive zoom tools andadvanced viewing options, such as real-time reference subtraction and alignment of traces to a step or a certain time,
are available while the experiment is running.

Octet® Analysis Studio Software
The Octet® Analysis Studio Sortware user interface is now
more interactive and updates automatically when settings
are changed. The latest software version contains all analyses, including quantitation, data processing and corrections, kinetics and epitope binning. All setting parameters
are saved locally in a new .efrd file to ensure user-customized settings are stored.

Data Preprocessing
The software allows overlay of multiple experiments andplates for simplified viewing. Datasets can also beappended and analyzed simultaneously, reducing analysis
time from hours to minutes. Hundreds to thousands ofsamples can be visualized, processed, analyzed and presented in the final report, so an entire campaign or projectto select leads from the global dataset (Figure 1).
Octet® Analysis Studio Software with an interactive interface offers more flexible tools for customizing data analysis
that caters to users at all experience levels. There are norestrictions on reference sample(s) placement, andadvanced options for reference subtraction are available
that remove any non-specific binding and/or baseline drift(Figure 2). For rapid analysis of multiple plates that were runusing similar experiment setups, the same reference subtraction and data corrections applied to one plate can also
be applied automatically to other plates in the dataset.
Advanced inter-step correction options remove bulk shifts
or artifacts to ensure data has been appropriately processed prior to fitting (Figure 3).

Figure 1: 10 large molecule kinetics datasets overlaid and combined to significantly speed up analysis and viewing.

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Report point values can be added to any step in the sensor
trace, providing flexibility of comparing loading, baseline,
association or dissociation levels between traces. This feature is especially useful in assessing loading levels, analyte
association levels, as well as early and late dissociation levels in screening applications such as ranking several clones
based of off-rates.

Kinetics Analysis
Multiple interactions from several plates or experiments can
now be fitted and evaluated in parallel (Figure 4). Faster andmore optimized 1:1 and 2:1 algorithms enable better fittingwith lower residuals and rapid analysis for large datasets.
Once analysis is complete, customized reports can be created by combining various data elements such as graphs,
text, data tables, company logo, images and experimental
details (Figure 5). Reports are then ready to be uploaded toan electronic notebook or stored in the database. Reporttemplates can be saved and re-loaded to make similarreports for additional datasets.

Figure 4: Kinetic analysis on a combined dataset.
Figure 2: More flexible reference subtraction options.

Figure 3: Advanced data processing option to remove bulk shifts orassay artifacts.

Figure 5: Customized experimental report.

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Quantitation Analysis
Octet® Analysis Studio Software also enables multi-experiment analysis of quantitation datasets that significantly
speeds up analysis of multiple plates (Figure 6).

Figure 6: Multi-experiment quantitation analysis.

Figure 7: Quantitation binding rate calculation and curve fitting.

4Simple 1-step and multi-step quantitation assays can beeasily analyzed with a few clicks. Extended data preprocessing options are available to perform one or multiple reference subtractions depending on the assay setup. Once thedata has been processed, binding rate is calculated basedon initial slope or rate at equilibrium. The data can then be
fitted using unweighted or weighted 4 parametric (4-PL)
5-PL or linear fits (Figure 7).

Automated sample alert tools are now available that analyze
data quality for the magnitude of precision between replicates, accuracy, dilution linearity and residuals, enabling
interpretation of results with confidence (Figure 8). Customized reports, similar to Figure 5, can also be generated.
Once quantitation analysis is complete, customized
reports can be created by combining various data elements such as graphs, text, data tables, company logo,images and experimental details as described earlier.
Reports are then ready to be uploaded to an electronic
notebook or stored in the database.

Figure 8: Sample alert tools.

Dose-Response Analysis Capabilities
Determination of product activity is vital during drug development and manufacturing to ascertain the intended biological activity of the therapeutic. A potency orpotency-indicating assay is a requirement by regulatory
bodies before the release of every manufactured drug lot.
Typically, potency measurements are obtained using bioassays in animal models or cell-based assays to capture biological activities directly. However, alternative assay formats
such as ELISA or BLI are used for potency measurements
when drug binding activities to target molecules correlatewith the biological activity of the drug. These assays arecoined as potency-indicating or surrogate assays for theirability to reveal drug activity based on target binding.
Octet® dose-response assays provide fast time to resultswith automated workflows, minimal hands-on times, andreduced assay variabilities. Unlike ELISA, all assay steps canbe monitored and evaluated in real time.

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Conveniently setup EC50 and IC50 experimentswith in‑built experimental method templates in
Octet® Discovery Software.
3-PL, 4-PL, 5-PL, linear, and semi-log fitting algorithmsMonitor biosensor loading responses and flag data points
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

Figure 9: Anti-Her2 lot-to-lot potency evaluation using an Octet® potency assay. Relative potency evaluation between two anti-Her2
antibody lots using the binding activity to Her2. Dose-repose binding data from multiple lots were fitted globally to a 4-PL fitting
algorithm in Octet® Analysis Studio Software.

5Epitope Binning
Epitope binning groups a panel of monoclonal antibodies(mAbs) into bins based upon similarities in antigen recognition sites or epitopes. This grouping is performed using
cross com­petition assays, in which the competitive binding of antibody pairs to a specific antigen is characterized.
If the binding of antigen to one mAb prevents the bindingof another mAb, then these mAbs are considered to bindto similar or overlapping epitopes. If binding of a mAb tothe antigen does not interfere with the binding of theother mAb, then they are considered to bind to distinct,
non-overlapping epitopes. Two criteria must be fulfilled inorder to assign mAbs into the same bin. First, all mAbs inthe same bin should block each other’s ability to bind theantigen. Second, all mAbs in the same bin should havesimi­lar blocking profiles when paired with other mAbs inthe panel.
The BinChart feature assigns screened antibodies to bins
based on the binding threshold set during analysis. Thisbinding threshold can be adjusted to analyze varying binning of antibodies as a result of the changing threshold(Figure 10).

Figure 10: Example BinChart from a 32x64 screen. Each bin represents antibod­ies that block each other’s ability to bind theantigen, and have similar block­ing profiles when paired with other antibodies in the panel. In this example, a higher binding nmthreshold setting was used.

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21 CFR Part 11 Compliance Features
Recent enhancements to our Octet® CFR Software enable
all Octet® instruments to be integrated seamlessly into GxPregulated environments (Figure 11).

-----21 CFR Part 11 Compliance features include:
Primary data integrity
Control access with multiple user levels
Enhanced Audit Trails
Electronic Signatures
Full control for routine assays and speed up analysis
Customized reports

Automated Acquisition and Analysis
for All Types of Octet® DataOctet® BLI Discovery and Octet® Analysis Studio Software
provide support for an automation interface through a
Serial Port (RS-232) or a Transmission Control Protocol/
Internet Protocol (TCP/IP) socket for Octet® RH16 andRH96 instruments. Octet® Analysis Studio Software alsoenables automated analysis of all types of datasets, including quantitation, kinetic, dose-response and epitope binning data which was not previously possible. Theautomation interface was designed to be as universal aspossible, making no assumptions about the communication
medium or the language of the client application connecting to Octet® Software.

Figure 11: Octet® Data Analysis Studio CFR Software’s new Security tab. User info, including username and privileges, are on the left panel. Audit Trail
details are in the middle and the old vs. new values are on the right panel on the Security tab.

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Octet® BLI Discovery Software Version Feature Comparison
FeatureV11.xV12.x

V13.x

V12.x

V13.x

Increased flexibility in Kinetic method generation when entering dilution factors anddesignating controls
Increased flexibility in Advanced Quantitation method generation – more step types and reuse
step types
Customize default settings – plate type, plate definition (row, columns, or quadrants) and data input
Support for glycoanalysis biosensors (GlyS/GlyM)
Shortcuts to minimize number of clicks
Support for the Biosensor Mount Cleaning Tool for Octet® RH16 and RH96 systems
Support for Octet® R8 system and its microplate evaporation cover consumableExperiment Wizard includes built-in protocol templates for kinetics, quantitation, andepitope binning
Additional concentration units for virus analysis VP/mL, VG/mL, GC/mL, and CP/mL
Data bridge interface to import Ambr®15 data, and optimize Octet® sample layout assignments
Ability to assign a file locations for routine data transfers between Ambr®15 Software andOctet® Discovery Software
Displaying both sample and reagent plate temperatures in Octet® RH16 and RH96 systems
Built-in method templates for dose-response experiment setup
Ability to continue using Octet® RH96 systems with up to two malfunctioning lamps until service
is performed to reduce instrument downtimes

Octet® Analysis Studio Software Version Feature Comparison
FeatureAutomated analysis of datasets
Available as a 64-bit application
Ability to sort multiple fields in data tables
Pre-defined analysis settings import to maximize speed
Automated kinetic analysis of multiple plates
Automated epitope binning analysis of multiple plates
Automated quantitation analysis of multiple plates
Dose-response analysis automation for data analysis and report creation
Automated quantitation data export to Ambr®15 file formats
Data preprocessing
Cross-plate referencing
Epitope Binning: ability to exclude full sensor trace
Epitope Binning: ability to export data to a csv file
New buttons for reference assignment for better usability
More editable columns for flexibility - loading sample ID, loading concentration, dilution factor
Perform data processing for a combined data from multiple experiments, plates and/or
biosensor traysMore flexible referencing options – by column, row, selected wells, pairs, pattern and between
biosensor trays

8V11.xOctet® Analysis Studio Software Version Feature Comparison (continued)
FeatureAdvanced inter-step correction to remove bulk shifts or assay artifacts
Report point feature for whole sensor traces – can be added in any step in the trace
More graphical options – thicken line, change trace colors, customize x- and y-axis scales
NEW Dose-response analysis
3-PL, 4-PL, 5-PL, and linear fitting algorithms for EC 50 /IC 50 analysis
Independent and global data fitting of dose-response data
Ability to manually constrain upper and lower asymptote, and hill slope
Automatic assignment of loading, sample, and detection steps in data cycles
Availability of stacked, individual, and pairwise plot views
Calculate and report biosensor immobilization statistics and flag data cycles based on a user definedloading variability threshold
Ability to assign standard groups for relative EC 50 /IC 50 analysis between sample groups
Ability to normalize response values to a user specified standard sample group
Export dose-response data and results to CSV. and Excel file formats
Epitope binning analysis
BinChart for automated binning of antibodies
Color schemes for Matrix display
Ability to export BinChart, original and corrected matrix, table with clustering info
Enable sample ID and information correction, if necessary
Copy epitope binning matrix image
Subtract self-binding in the matrix
Subtract the matrix against a select row or column
Append or overlay data from multiple experiments, plates and biosensor trays
Automatically create 2D traffic light matrix
Kinetic analysis
Ability to use multiple parameters in global fitting groups
Analyze kinetic cycles with different association/disassociation times in the same experiment file
Batch export of group graphs to image files
Pause auto-fitting of kinetic datasets option
Flip data option
Enable kinetic analysis of multiple experiments that can be visualized together in All Assays tab
More graphical options – thicken line, tooltip, legends, custom y-scaling
Additional data table with individual fitting groups for a concise data view
Additional data table with for reporting steady-state analysis by fit group
Quantitation analysis
Overlay fitted traces on top of raw binding traces
Exportable Fitted Graph that shows binding signal and curve fit for each sample well
Advanced option to choose the model classifier for binding rate determination
Pause auto-fitting of quantitation datasets option

9V11.x

V12.x

V13.x

Octet® Analysis Studio Software Version Feature Comparison (continued)
Feature

V11.x

V12.x

V13.x

V11.x

V12.x

V13.x

One step or one step type (when regeneration is performed) can be quantitated from a kinetic assay
Enables quantitation analysis of multiple experiments and plates by forming a single, combinedmega dataset
Standard curve sorted automatically by sensor type if multiple types of sensors are used in anexperimentMore advanced sample alerts for data quality
Custom report generation
Multi-page table support for large experiments
Formatting and sorting capability for data tables
Add residual, steady-state, iso-affinity, XY scatter and grouped graphs to report
Add experiment summary, sensor tray layout, sample plate layout, graphs and tables from any
analysis module – quantitation, kinetics, preprocessing or epitope binning
Add text boxes and any image(s)Export the report in PDF format or print a hard copy
Save report template and load to generate similar reports for other datasets
Create custom reports for presenting dose-response dataOctet® 21 CFR Part 11 SupportFeature
Ability to authorize users to remove signatures from an analysis file
Ability to inactivate the default Administrator accountMore detailed audit log of changes made within ForteBio Server Monitor
Ability to choose time zone and date/time format
New Security tab in Octet® Analysis Studio Software
Controlled access with multiple user levels and expanded privilegesElectronic signatures to lock dataset and prevent changes after analysis is complete
Digitally signed data files that are invalidated if any modification is made outside the software
Log all critical user actions in Octet® BLI Discovery and Analysis Studio Software Audit Trail withold versus new values
Audit Trail can be filtered by project, machine, user, experiment and date interval
Exporting Audit Trail and user information to PDF reports
Option to add customized comments to each analysis event in Audit Trail
Full control over running and analyzing routine assays in regulated labs
Lock all Microsoft® Excel® export reports
Software Validation Package product support
Ability for users with administrative privileges to force users to change a password at next log-in10(New doseresponse)Germany
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Phone +49 551 308 0

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www.sartorius.com/octet-support

Specifications subject to change without notice.
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