GxP Compliance Tools for Octet® Systems

From antibody quantitation, ligand binding characterization to potency assays, Sartorius offers a wide range of GxP compliance tools for developing validated assay methods on the Octet® BLI platform

  • Comprehensive tools for GxP compliance
  • Simplicity in operations for analytical development and regulated quality control labs

Availability of a comprehensive tool set for compliance makes the Octet® BLI platform an ideal analytical instrument in regulated quality control (QC) labs for lot release and in-process testing for ligand binding, concentration, and impurity analysis in both upstream and downstream processes.

Sartorius Solutions for GxP Compliance

Compliant Installation and Operational Qualification (IQOQ) Kit and Services

The IQ/OQ kit provides comprehensive documentation to verify the Octet instrument, accessories and computer system are supplied and installed per Sartorius's guidelines by certified personnel. It also provides documented verification that the Octet instrument operates as intended at the user site by inspecting the critical components. These tests verify that the various key operational parameters, such as the optical system, plate temperature, system alignment, lamp performance, and shaker speed meet stipulated specifications.

Performance Qualification Kits

PQ kits provide rapid and convenient methods to verify the performance of your Octet® R8 and RH16 systems. PQ can be performed using one or two tightly controlled assays, depending on the instrument’s intended use. The PQ-Kinetics and quantitation assays verify accuracy and precision of the assays are within specifications for a well- characterized model system pair.

Octet® CFR Software and Software Validation Package

For researchers working in GLP or GMP laboratories, the Octet® Software Validation Package provides the most comprehensive documentation and tools available to validate the Octet® GxP Server Monitor and Octet® CFR Software features and functions. It trims validation time to just three days using a fully -integrated manual that mirrors the validation process in a regulated laboratory and provides sample data sets to authenticate analysis within Octet® software to traditional programs including Microsoft® Excel®, and GraphPad Prism.

Biosensor Validation Service

This service enables the Octet® system users to sample multiple lots of a biosensor during assay qualification and validation and reserve a well-characterized lot for purchase. The service is available for the following biosensor types: Octet® ProA , Octet® SA, Octet® SAX, Octet® NTA, and Octet® AMC. Customers can order up to five different biosensor lots, up to 20 trays from each lot for evaluation, and reserve up to 40 additional trays for future purchase.



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Applications

Active Antibody/Protein Concentration Determination

ELISA assays can be directly transferred for confident concentration determination on Octet® BLI systems.  These assays reduce the variability, labor-intensive workflow, and slow times-to-result of traditional ELISAs.

Read Application Note

Ligand Binding and Potency Assays

Octet® BLI instruments are increasingly being used for the development of analytical methods for ligand binding to target and potency assays for lot release.
Sartorius offers ready-to-use biosensors for the immobilization of a variety of ligands including Fc-gamma receptors for affinity measurements and potency assays. Octet® BLI systems are especially suitable for these assays as they decrease method development time significantly compared to SPR and ELISA.

Read Application Note

protein contaminant diagram

Protein Contaminant Testing

Protein contaminants are a major hurdle to overcome during the production of biopharmaceuticals. The Octet® platform's rapid high throughput protein analysis combined with the anti-CHO HCP and Residual Protein A kits  provide biologics developers with a fast and easy-to-use assay for contaminant testing.

Download Technical Note

Stability & Forced Degradation Studies

Stability indicating assays are a key requirement by regulatory bodies for analytical procedures used to monitor the stability and activity of drug molecules. The Octet® BLI platform can also be used to rapidly develop stability-indicating methods and are suitable for measuring and distinguishing between fully-functional drug products and those whose binding activities have been changed.

Read Application Guide

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Featured Resources

7000+ Octet publications New
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Octet® Publication Database

Literature references covering a large variety of research areas and applications

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Application Guide

Harmonizing Regulatory Guidelines for Assay Validation

Current regulatory guidelines for assay validation were harmonized for kinetic-based assay to derive a common set of parameters.

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Application Guide

Ligand Binding Assays That Meet Compliance with Octet® BLI Systems

Octet® GxP packages support the GMP compliant implementation, including 21 CFR Part 11 software, validation packages, and biosensor validation support...

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Analysis of Fc-Gamma Receptor-IgG Interactions on the Octet® Platform
Application Note

Analysis of Fc Gamma Receptor IgG Interactions on Octet® Platform

Whether you're assessing FcRn-Antibody or FcγR-IgG binding interactions, you need a high throughput, versatile, and easy to use solution.

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Analysis of FcRn-Antibody Interactions on the Octet® Platform
Application Note

Analysis of FcRn-Antibody Interactions on the Octet® Platform

Assay design recommendations and best practices for producing the highest quality of kinetic data.

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app note cover
Application Note

Customized Quantitation of Recombinant Therapeutic Proteins

Using Octet® SAX Biosensors

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Application Note

Potency Assay Development Qualification and Validation Strategies

A method for evaluating the binding of an Fc gamma receptor III (FcγR) molecule to the widely characterized NIST mAb.

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Validated Quantitation and Activity Assay of Antibody Fragment Molecule (Fab) for Process Development and Quality Control
Application Note

Validated Quantitation and Activity Assay of FaB

For Process Development and Quality Control

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Enhanced Efficiency in Lot Release and In-Process Testing of Biologics cover
White Paper

Enhanced Productivity and Labor Efficiency

In Lot Release and In-Process Testing of Biologics in GxP Laboratories

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Octet Kinetics Assay Method Development Guideline thumbnail
Technical Note

Octet® Kinetics Assay Method Development Guideline

Developing kinetics binding assays to establish specificity, accuracy, precision, linearity and range as stipulated by USP 1032

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Octet® Systems: Modernize Biopharmaceutical QC Testing to Increase Efficiency
Application Guide

Modernize Biopharmaceutical Quality Control Testing

Quality control of biological products to support clinical trials and post market assay activities require the evaluation of multiple critical product...

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Poster

High Productivity and Process Economy in GxP Applications

Quantitation assays must show precision, accuracy, linearity, and reproducibility

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Examples of Approved Drugs Utilizing Octet® BLI Data in Their Applications

This table includes examples of drugs where the Octet® BLI system has been used to generate data submitted as part of the supporting information for the drug’s approval with regulatory bodies.


Drug Name

Target

Drug Modality

Sponsor

Regulatory Agency

Indications

Application

Year of
Approval

Keytruda | Pembrolizumab

PD-1

mAb

Merck

EMA

Non-small cell lung cancer

Affinity Characterization

2015

Tecentriq | Atezolizumab

PD-L1

mAb

Roche

EMA

Non-small cell lung cancer

Specificity

2017

Comirnaty | BNT162b2

COVID-19

mRNA Vaccine

Pfizer

EMA

COVID-19

Affinity Characterization

2020

Ultomiris | Ravulizumab

Human C5

mAb

Alexion

EMA

Paroxysmal nocturnal hemoglobinuria (PNH)

Affinity Characterization

2019

Livogiva | Teriparatide

PTH

Peptide Biosimilar

Teva

EMA

Osteoporosis

Affinity Characterization

2020

Atoltivimab, maftivimab, and odesivimab-ebgn

EBOV glycoprotein

mAb Cocktail

Regeneron

FDA

Ebola virus

Competition studies

2020

Oyavas | Bevacizumab

VEGF-A

mAb Biosimilar

Mabxience

EMA

Non-small cell lung cancer

Specificity | Affinity Characterization

2021

Jemperli | Dostarlimab

PD-1

mAb

GSK

EMA

Endometrial cancer

Affinity Characterization

2021

Regdanvimab

S protein

mAb

Celltrion

EMA

COVID-19

Affinity Characterization| Blocking Assay

2021

Xevudy | Sotrovimab

S protein

mAb

GSK | Vir Biotechnology

EMA

COVID-19

Affinity Characterization

2021

Nuvaxovid

COVID-19

Vaccine

Novavax

EMA

COVID-19

Affinity Characterization

2022

Kimmtrak | Tebentafusp

CD3 | gp100

TCR

Immunocore

EMA

Uveal melanoma (UM)

Specificity

2022

Tixagevimab | Cilgavimab

COVID-19

mAb Combination

AstraZeneca

FDA

COVID-19

Affinity Characterization|  Blocking Assay

2022

Opdualag (nivolumab | relatlimab)

LAG-3 | PD1

mAb Combination

BMS

EMA

Melanoma

Blocking Assay

2022


datasheet thumbnail
Datasheet

Octet® CFR Software V12.X and Software Validation Package Datasheet

PDF | 197.7 KB
Datasheet: Octet Data Analysis HT Software Version 13
Datasheet

Datasheet: Octet® Software Version 13

PDF | 409.1 KB
Datasheet

Octet System Qualification Products and Services

PDF | 99.8 KB
app note cover
Application Note

Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics

PDF | 372.5 KB
Octet RH16 with Lab Tech
Application Note

Converting ELISA Assay Into Octet® Quantitation Assay

PDF | 207.5 KB
application guide thumbnail
Application Guide

Quality Control Of Biotherapeutics Using Octet® Systems

PDF | 1.9 MB
CHO Host Cell Protein Detection
Technical Note

CHO Host Cell Protein Detection

PDF | 1.3 MB
Technical Note

High Precision Streptavidin Biosensor (SAX) Quantitation and Kinetic Assays

PDF | 3.6 MB
Octet Instrument Comparability Kinetics Precision Assessment
White Paper

Instrument Comparability Assessment: Kinetics Precision Assessment in Ligand Binding Assays on the GxP-Compliant Octet® RED96e and Octet® R8 Instruments

PDF | 1.3 MB

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