Biologics GxP Applications
Label-Free Assays for Process Development and Quality Control (QC)
Biological drug products must be quality control (QC) tested using robust methods that are appropriately qualified and validated under GMP conditions. The Octet® BLI platform facilitates method development for in-process and lot release testing that can be easily transferred to QC. The ease-of-use and high throughput capacity of Octet® systems allow for enhanced productivity of up to 40x over enzyme-linked immunosorbent assay (ELISA).
Octet® BLI systems come ready for good manufacturing practice (GMP) implementation with:
- Octet® CFR software and server applications for secure and traceable electronic record keeping
- Optional IQ/OQ/PQ packages to qualify instruments are installed, operating and performing as intended
- Support services and biosensor validation
Featured Applications
Fc Receptor Binding Assays
Fc Receptor Binding Assays
The safety and efficacy of a therapeutic monoclonal antibody can be greatly impacted by its binding to both the target and to the FcγR. Antibodies are often engineered to achieve desired properties, including binding to FcγRs.
Octet® BLI systems offer a high throughput and sensitive solution for Fc receptor binding analysis, with a variety of assay-ready biosensor surfaces available for rapid and flexible assay development.
Ligand Binding Potency Assays
Reproducible and accurate relative ligand binding potency methods can be used to assess lot-to-lot variability by monitoring either the drug binding response or the kinetics of binding including affinity constants. An ideal method must be stability-indicating as well.
The Octet® BLI platform is increasingly used for assessing the potency of drug candidates. Octet® BLI systems:
- Readily accommodate the use of Design of Experiment (DOE) to rapidly develop robust potency measurement methods
- Provide relative affinity constant or response signals for potency measurements and comparability studies
Titer Determination
The active protein concentration can be used to determine the potency of the drug molecule. Octet® instruments can be used to develop methods that measure active protein levels. Traditional protein concentration determination techniques like HPLC are being supplanted by more robust Octet® BLI assays in both upstream and downstream bioprocesses. These assays enable:
- Measurement directly from crude and unpurified samples, like cell culture media
- Obtain IgG titer for a full microplate of 96 samples of in as little as two minutes
- Walk away with automation capable with Octet® RH96 and RH16 systems
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 |
Featured Resources
Instant Access
Instrument Comparability Assessment: Kinetics Precision Assessment in Ligand Binding Assays on the GxP-Compliant Octet® RED96e and Octet® R8 Instruments
PDF | 1.3 MB
Enhanced Productivity and Labor Efficiency in Lot Release and In-Process Testing of Biologics in GxP Laboratories
PDF | 924.3 KB
