Product Datasheet

Octet Software Version 13®

Added Features to Improve EC50, IC50
and Potency Analysis-New Key Features
New EC50 and IC50 analysis capabilities to determine
drug product activities using surrogate potency assays,
reducing assay variability, timelines, and costs
Data bridge to support data transfer between
Sartorius Octet® and Sartorius Ambr® bioreactor
systems to accelerate cell line development workflows

Overview
Sartorius Octet® BLI Discovery and Analysis Studio
Software are evolving to address growing applications,and user needs with every release version.

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 or potencyindicating assay is a requirement by regulatory bodies
before the release of every manufactured drug lot. Typically,
potency measurements are obtained using bioassays inanimal models or cell-based assays to capture biologicalactivities directly. However, alternative assay formats suchas ELISA or BLI are used for potency measurements when
drug binding activities to target molecules correlate withthe biological activity of the drug. These assays are coined
as potency-indicating or surrogate assays for their ability toreveal drug activity based on target binding. Octet® doseresponse assays provide fast time to results with automatedworkflows, minimal hands-on times, and reduced assay
variabilities. Unlike ELISA, all assay steps can be monitored
and evaluated in real time.

--

Conveniently setup EC50 and IC50 experimentswith built‑in experimental method templates inOctet® Discovery Software.
3-PL, 4-PL, 5-PL, linear, and semi-log fitting algorithms
Monitor 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
Create customized data reports for presenting andreporting dose-response data and conclusions

Figure 1: 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.

2Octet®- Ambr® 15 Data BridgeOctet® BLI platforms are routinely implemented in
upstream and downstream cell line development
workflows measuring critical quality attributes (CQAs) suchas product titer, binding activity, or glycosylation ranking.
The Ambr® 15 is an automated high-throughput single-use
bioreactor system that provides parallel operation of up to48 single-use microbioreactors at a time where multiple cellculture experiments can be used to evaluate different celllines, clones, or to identify desirable cell culture processparameters. Ambr® cell culture workflows are often
combined with label-free binding assays due to fast time
to results and minimal hands-on time.

-Built-in Octet®-Ambr® data bridge in Octet® BLI
Discovery Software for importing Ambr® sample andcondition information, saving analyst time and eliminating
data transfer errors.*
Directly import Ambr® 15 sample plate map
configurations with experimental information, rearrange
sample well positions for Octet® assays, and modify
sample information or replicate groups using theOctet®-Ambr® 15 data bridge.
Preconfigure data import and export file locations tostreamline data import and export to and from theOctet® to Ambr® 15 data bridge.
Seamless transfer of Octet® data analytics from Octet®
Analysis Studio Software to Ambr® Software for
integrating cell culture analytics for faster data feedback.*

A.

B.

Figure 2: Ambr® 15 process data import to Octet® BLI Discovery Software for product concentration measurement in the Octet® system. (A) The newdata interface allows for importing critical sample information from Ambr® 15 process runs. Users can track sample information and reconfigure sample
plate maps suitable for the Octet® assay without manually entering information in the Octet® Software. (B) Ambr® 15 sample information is
automatically populated for an Octet® experiment and method set up in Octet® BLI Discovery Software.

New Virus Concentration Units

Specifications

Setup, calculate, and report virus concentration data
in VP/mL, VG/mL, CP/mL and GC/mL units in Octet®
BLI Discovery and Analysis Studio Software.

Component

Requirement

Processor

3.0 GHz Quad Core processor or greater

Operating system

Windows 10 orWindows 11 Professional, 64-bit

Reduce Experiment Downtimes Even
Further on Octet® RH96 Instruments

Memory4 GB RAM or greater

Graphic display

Monitor with 1920x1080 resolution or better

Hard disk

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

Additional software

Microsoft OfficeOctet® RH96 instruments are powered by multiple lamps
supporting the 96-channel read heads. In the event of amalfunctioning lamp, the Octet® BLI Discovery Software
will guide users to continue using the instrument with theremaining lamps and reduced throughput until service
on the Octet® instrument is completed to reduce
instrument downtimes.

*Use of Octet®-Ambr® 15 Data Bridge will require purchase of Ambr® 15
data interface license and require Ambr® Software version R10.0 or above.
3

Ordering Information

4Part No.

Description

50-5029

Upgrade of Octet® instrument software to the latest version of software. Includes 4 seat licenses. Includes Octet®
Software Version 13. Requires previous version of Octet® Software.

50-5098

4-seat licenses of Octet® Software version 13.X. Includes FREE upgrades within 13.X. Requires previous purchase(50‑5029) or installation of version 13.X software.

50-5099

1-seat license of Octet® Software version 13.X. Includes FREE upgrades within 13.X. Requires previous purchase (50‑5029)
or installation of version 13.X software.

50-5100

2-seat license of Octet® Software version 13.X. Includes FREE upgrades within 13.X. Requires previous purchase(50‑5029) or installation of version 13.X software.

50-5101

Site license for Octet® Software version 13.X for offline data analysis. Installation and use of the Octet® Software version
13.X at a physical site (single city or ZIP code) as defined in the purchase order. Includes FREE upgrades within 13.X.
Requires previous purchase (50-5029) or installation of version 13.X software.

50-5034

Upgrade of Octet® CFR instrument software to the latest version of software. Includes 4 seat licenses. Requires previous
version of Octet® CFR Part 11 Software.

50-5102

4-seat licenses of Octet® BLI CFR part 11 software version 13.x at a physical site (single city or ZIP code) as defined in thepurchase order. Includes FREE upgrades within 13.X. Requires previous purchase of Octet® BLI CFR part 11 Software
version 13.x.

50-5103

1-seat licenses of Octet® BLI CFR part 11 Software version 13.x at a physical site (single city or ZIP code) as defined in thepurchase order. Includes FREE upgrades within 13.X. Requires previous purchase of Octet® BLI CFR part 11 Software
version 13.x.

50-5104

2-seat licenses of Octet® BLI CFR part 11 Software version 13.x at a physical site (single city or ZIP code) as defined in thepurchase order. Includes FREE upgrades within 13.X. Requires previous purchase of Octet® BLI CFR part 11 Software
version 13.x or previous installation of a non-CFR Octet ® software. Includes 2 licenses.

50-5105

Site license for Octet® BLI CFR part 11 Software version 13.x at a physical site (single city or ZIP code) as defined in thepurchase order. Includes FREE upgrades within 13.X. Requires previous purchase of Octet® BLI CFR part 11 Software
version 13.x.

50-0300

13.X SOFTWARE VALIDATION PACKAGE. For researchers working in GLP or GMP laboratories, the Octet® Software
Validation Package provides comprehensive documentation and tools available to validate GxP administrator features,and quantitation and kinetics functions for data generated on Octet® instrumentation.

001-8B39Ambr® 15 Octet® data interface.

Germany
Sartorius Lab Instruments GmbH & Co. KG
Otto-Brenner-Strasse 2037079 Goettingen
Phone +49 551 308 0

 F
 or further contacts, visit

www.sartorius.com/octet-support

Specifications subject to change without notice.
Copyright Sartorius Lab Instruments GmbH & Co. KG.
For Research Use Only.
DS_4016 Rev C.
Status: 09 | 2022

USASartorius Corporation
565 Johnson Avenue
Bohemia, NY 11716
Phone +1 888 OCTET 75
Or +1 650 322 1360