GxP Compliance Tools
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.
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.
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.
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.
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.
Boost your research and commercialization goals by combining BLI and SPR at an attractive promotional price.
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
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.
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.
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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
Literature references covering a large variety of research areas and applications
A comprehensive tool set for compliance makes the Octet® BLI platform an ideal analytical instrument in regulated environments.
Current regulatory guidelines for assay validation were harmonized for kinetic-based assay to derive a common set of parameters.
Octet® GxP packages support the GMP compliant implementation, including 21 CFR Part 11 software, validation packages, and biosensor validation support...
Whether you're assessing FcRn-Antibody or FcγR-IgG binding interactions, you need a high throughput, versatile, and easy to use solution.
Assay design recommendations and best practices for producing the highest quality of kinetic data.
Using Octet® SAX Biosensors
A method for evaluating the binding of an Fc gamma receptor III (FcγR) molecule to the widely characterized NIST mAb.
For Process Development and Quality Control
In Lot Release and In-Process Testing of Biologics in GxP Laboratories
Developing kinetics binding assays to establish specificity, accuracy, precision, linearity and range as stipulated by USP 1032
Quality control of biological products to support clinical trials and post market assay activities require the evaluation of multiple critical product...
Quantitation assays must show precision, accuracy, linearity, and reproducibility
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 ofApproval
Keytruda | Pembrolizumab
PD-1
mAb
Merck
EMA
Non-small cell lung cancer
Affinity Characterization
2015
Tecentriq | Atezolizumab
PD-L1
Roche
Specificity
2017
Comirnaty | BNT162b2
COVID-19
mRNA Vaccine
Pfizer
2020
Ultomiris | Ravulizumab
Human C5
Alexion
Paroxysmal nocturnal hemoglobinuria (PNH)
2019
Livogiva | Teriparatide
PTH
Peptide Biosimilar
Teva
Osteoporosis
Atoltivimab, maftivimab, and odesivimab-ebgn
EBOV glycoprotein
mAb Cocktail
Regeneron
FDA
Ebola virus
Competition studies
Oyavas | Bevacizumab
VEGF-A
mAb Biosimilar
Mabxience
Specificity | Affinity Characterization
2021
Jemperli | Dostarlimab
GSK
Endometrial cancer
Regdanvimab
S protein
Celltrion
Affinity Characterization| Blocking Assay
Xevudy | Sotrovimab
GSK | Vir Biotechnology
Nuvaxovid
Vaccine
Novavax
2022
Kimmtrak | Tebentafusp
CD3 | gp100
TCR
Immunocore
Uveal melanoma (UM)
Tixagevimab | Cilgavimab
mAb Combination
AstraZeneca
Opdualag (nivolumab | relatlimab)
LAG-3 | PD1
BMS
Melanoma
Blocking Assay
Monitors up to 96 biosensors simultaneously, enabling label-free detection for protein quantitation and kinetic characterization at unmatched speed
Ideal for high-throughput applications that demand high sensitivity and low sample volume requirements
Unmatched flexibility and versatility in protein analysis
The perfect balance between cost and throughput with given leeway
Grows with your biomolecule characterization needs
Affordably priced label-free analysis for individual researchers on any budget
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