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
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.
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.
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.
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.
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.
Featured Resources
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 |
|---|---|---|---|---|---|---|---|
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 |
Enhancing Efficiency and Economics in Process Development and Manufacturing of Biotherapeutics
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