Biologics GxP Applications
Label-Free Assays for Process Development and QC
Biologics drug products must be QC tested using methods that are robust and are appropriately qualified and validated under GMP conditions. The Octet 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 the Octet systems allow for enhanced productivity of up to 40X over ELISA and up to 16X over select SPR instruments for certain applications.
Octet systems come ready for 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
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 systems offer high throughput and sensitive methods for Fc receptor binding analysis, with a variety of 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 platform is increasingly used for assessing the potency of drug candidates. Octet systems:
- Readily accommodates the use of DOEs to rapidly develop robust potency measurement methods
- Provide relative affinity constant or response signals for potency measurements and comparability studies
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 only the active protein. Traditional protein concentration determination techniques, like HPLC are being supplanted by more robust Octet assays in both upstream and downstream bioprocesses. With Octets:
- Measure directly in crude and unpurified samples, like cell culter media
- Obtain IgG titer for a full microplate of 96 samples of in as little as two minutes
- Walk away with automation capable Octet HTX and Red384 systems