Biacore systems allow for rapid, label-free interaction analyses, giving deeper insights into the interactions of proteins with other molecules, and leading to better decision making and increased productivity. The wealth of information provided by Biacore systems – binding kinetics, affinity, specificity, selectivity, and concentration measurement – is invaluable across many applications such as unraveling molecular mechanisms, fragment screening, vaccine research, antibody characterization, immunogenicity testing, process development, and quality control.
The systems also provide sensitive binding activity measurements. This is based on the ability of the biomolecule of interest to interact with a specific binding partner, and may therefore be more informative than generic measurement techniques (e.g., total protein concentration).
Biacore system validation support
Laboratories involved in pharmaceutical drug development and manufacturing must satisfy the GxP (GLP, GCP, GMP) regulations. Computer-controlled analytical systems used in GxP applications must be validated and properly maintained. Failure to comply with regulatory demands is not a viable option from either a safety or economic standpoint.
Validation is the process of establishing documented evidence of control and is absolutely necessary for gaining product approval. Computer system validation ensures that:
- Hardware and software function as designed
- The process is controlled at all stages
- Data are processed as intended
- Offers a versatile, multi-application solution for detailed studies of biomolecular interactions – in real time with exceptional sensitivity. Wizard-supported software for assay development, analysis, data evaluation and interpretation makes the system straightforward to use. Applications, such as antibody characterization, which could take a week by conventional methods, can be completed in days.
- Biacore C is an automated Surface Plasma Resonance (SPR) system specifically designed for concentration determination of biopharmaceuticals in GLP/GMP applications. Increasing speed and quality of concentration analysis, while meeting stringent regulations is essential for ensuring success in drug development and manufacturing quality control (QC). Biacore C has user-friendly software and advanced instrumentation, which provide comprehensive assay control, high quality data, and high reproducibility with minimal sample usage, thereby increasing efficiency and saving costs.