Biophysical Characterization

Biophysical characterization is a crucial aspect in the development of protein-based therapeutics, including monoclonal antibodies and biosimilars and to determine the biological function and stability of said protein/biotherapeutics. Biophysical characterization is a powerful tool for ensuring the safety, efficacy, and quality of protein-based drugs.
The key applications of the biophysical characterization are:
– Quality Control and Consistency across different production batches and even manufacturers by comparing biophysical properties (such as High Order Structure, aggregation, and stability)
– Biosimilarity Assessment to ensure similarity between generic versions of biologics. This is done by comparing the High Order Structure of the biosimilar with the original product ensuring similar structure and function, which is crucial for regulatory agencies
– Development of drug formulations: to understand the protein stability under different conditions (pH, temperature, excipients)
– Stability Studies: where accelerated assays determine the protein stability during storage and transportation by subjecting proteins to stress conditions (e.g., high temperature, agitation)
– Aggregation and Immunogenicity: to detect and quantify protein aggregates, minimizing the risk of immunogenicity
– Comparability Studies: to assess if the changes to a biologic process (e.g., manufacturing process, cell line), impact on product quality without affecting critical attributes
– Protein Engineering and Design: where with the biophysical data, protein engineers may modify biologics to improve stability, solubility, and activity.