Today, we are analyzing more drug candidates with a wider range of modalities, all with the understanding that speed to market is more critical than ever before. As a result, scientists working on these candidates are looking for ways to increase throughput while maintaining robustness and reproducibility. While automated capillary electrophoresis (CE) instruments provide quicker separation times and high reproducibility, these systems operate using a single capillary format that offers limited throughput. To address these challenges, SCIEX recently launched the BioPhase 8800 system (Figure 1), an electrophoresis platform that utilizes a multi-capillary format that can raise throughput by allowing the characterization of multiple samples in parallel.
The BioPhase 8800 System from SCIEX
The BioPhase 8800 system is a multi-capillary electrophoresis system that enables the simultaneous analysis of eight samples while retaining the capability of delivering sensitive and robust capillary electrophoresis sodium dodecyl sulfate (CE-SDS) and capillary isoelectric focusing (cIEF) results. This accelerates the development and execution of sensitive, high-throughput analytical methods.
The increased throughput of the system minimizes bottlenecks in the drug development pipeline, helping to reduce time to market. By allowing scientists to screen more candidates faster and assess the molecular liabilities of their candidates more quickly, the selection of candidates for advancement is streamlined. This also enables the detection and characterization of any changes that occur with a drug candidate during development. The quick turnaround time helps to retain sample integrity between the first and last sample, which helps increase reproducibility. Lastly, companies can use the design and features of the BioPhase 8800 system to facilitate compliance with 21 CFR Part 11.
Scientists who have been using the single-capillary PA 800 Plus system can smoothly transition their assays onto the multi-capillary BioPhase 8800 system. Excellent comparability was demonstrated between the PA 800 Plus system and the BioPhase 8800 system (Figure 2).
Intuitive System Usage
To enable efficiency and a short, shallow learning curve, the BioPhase 8800 system utilizes user-friendly acquisition and analysis software that can decrease data processing time by multiplexing data integration. In addition, pre-assembled and temperature-controlled cartridges help ensure maximum data reproducibility. Reagent and consumable kits simplify operation, streamline workflows and minimize user error (Figure 3). In addition, switching between UV and LIF detectors is as simple as a mouse click.
The BioPhase 8800 system provides flexible, high-throughput, high-sensitivity analysis for bioprocessing, analytical development and QA/QC for the following analyses:
- CE-SDS: automated, quantitative and repeatable size-based separation of proteins
- cIEF: rapid and reproducible charge heterogeneity analysis via multi-capillary isoelectric focusing
- CGE: seamless method transferability and multi-capillary throughput for a multitude of nucleic acid species
Application Areas for BioPhase 8800 System
- Purity assessment of monoclonal antibodies (mAbs) and other protein therapeutics as well as proteins from lentivirus (LV) and adeno-associated vectors (AVVs)
- Charge heterogeneity analysis of therapeutic proteins
- Size and purity assessment of RNA-based vaccines and therapeutics
- Size and purity assessment of other nucleic acid species
Lastly, SCIEX offers full assistance, software training and the SCIEX Now support network to help support their customers’ analytical work.
For more information, please see BioPhase 8800 system
For more information, please see RNA 9000 Purity & Integrity kit