Confidently Characterize, Identify, and Quantify Protein Aggregates
The safety and efficacy of protein-based therapeutic agents such as monoclonal antibodies are highly dependent on the correct primary, secondary, ternary, and quaternary structure of the complex protein molecule. This includes, among other qualities, aggregation status.
Aggregation can occur during development, production, purification, storage, handling and even transportation. Aggregated proteins can lead to incorrect dosage, activity loss, decreased solubility, and dangerous, even fatal, immune responses. Monitoring aggregates is vital for drug safety and quality assurance. That’s why regulatory bodies require thorough characterization of protein aggregation in each stage of the manufacturing process.
Several methods can be used to analyze aggregation:
- The advantage of UV spectroscopy as an analytical method to detect the presence of protein aggregation is that it is non-destructive. It also uses low sample volumes, requires minimal sample preparation, and provides easy sample analysis.
- Size exclusion chromatography (SEC), which separates particles according to hydrodynamic size, is the method of choice for the quantification of aggregates in biotherapeutic samples. SEC coupled to UV detection and Agilent’s dynamic laser light scattering Multi-Detector Bio-SEC system can be used to analyze low levels of aggregation.
- Hydrophobic interaction chromatography (HIC) has also received great interest as an orthogonal technique to SEC. HIC separates proteins based on their hydrophobicity in the native state and can often detect changes in protein structure as well as aggregates.
Agilent offers a range of high-resolution inert SEC columns and detection systems to help scientists to routinely analyze and monitor aggregation and fragments from the main biopharmaceutical products.
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