Control and analysis of protein aggregation is an increasing challenge to pharmaceutical research and development. Aggregation of antibody drugs is a crucial concern with respect to their safety and efficacy. Creative Proteomics provides cutting-edge solutions for antibody drug aggregation analysis. Our advanced chromatography and mass spectrometry-based technologies accurately assess the formation of protein aggregates, providing quality and safety assurance during the development of antibody therapeutics.
Fig. 1 Engaging with Raman Spectroscopy to Investigate Antibody Aggregation
What is Protein Aggregation?
Antibody molecules are susceptible to aggregation due to spatial alteration of proteins caused by post-translational modifications, shear forces from transportation, impurities, pH changes, etc., resulting in spatial complementarity and charge complementarity. The phenomenon of protein aggregation is a common issue that compromises the quality, safety, and efficacy of antibodies and can happen at different steps of the manufacturing process, including fermentation, purification, final formulation, and storage. In addition, antibody aggregation increases the immunogenicity of antibody drugs, promotes the production of anti-drug antibodies, and reduces drug efficacy, so close monitoring is required.
Fig. 2 The process of protein folding and aggregation. (Li, W.; et al., 2016)
Protein Aggregation Analysis Services at Creative Proteomics
- Apply a range of protein aggregation analysis techniques to detect and aggregates in samples.
- Qualitative assessment of sample molecular weight and presence of aggregates.
Protein Aggregation Analysis Techniques
Creative Proteomics offers advanced analytical technologies for aggregate detection, characterization and quantification. Through these technologies, our team of experts can accurately assess the extent of drug aggregation, providing valuable information necessary for product formulation, manufacturing process optimization and regulatory submissions.
Features and Advantages of Protein Aggregation Analysis Services
- Cutting-edge analytical techniques
We use advanced chromatography-based techniques to enable comprehensive characterization and assessment of antibody drug aggregation at the molecular level.
- Quantitative and qualitative analysis
Our comprehensive characterization services enable qualitative and quantitative analysis of aggregates formed in antibody drugs, resulting in data that can help in the optimization of relevant processes.
- Professional data analysis
Our laboratory personnel have accumulated extensive experience in experimental operations and data analysis to ensure that we provide you with professional, comprehensive data interpretation.
Creative Proteomics provides professional services to analyze and characterize protein aggregates in samples to support customer needs in antibody drug development, quality control and stability studies. Contact us to learn more about our protein aggregation analysis services of antibody drugs. We will be happy to assist you.
Reference
- Li, W.; et al. Antibody aggregation: insights from sequence and structure. Antibodies. 2016, 5(3): 19.
