Da Yu Protein Sciences – Biophysical Characterization
Da Yu Protein Sciences has expertise in many biophysical techniques and offers services in Circular Dichroism Spectroscopy, Fluorescence Spectroscopy and UV Derivative Spectroscopy to its clients. Biophysical characterization is used during a Biologic’s life cycle in at least 3 specific areas:
- Product Characterization
- Formulation Development
- Comparability Testing
Biologics, such as monoclonal antibodies and recombinant proteins, are expected to be well characterized during CMC development. Biophysical techniques assist in characterizing the protein’s secondary and tertiary structure. Perturbations in these structures are examined during formulation development by intentionally changing environmental conditions such as pH and temperature.
Changes in a protein’s manufacturing process, whether during development or after licensure, should be supported by a comparability study to ensure the change has not impacted the protein’s quality. Changes impacting a therapeutic protein’s quality may adversely affect its safety and efficacy. Comparability testing begins with laboratory analyses that examine a protein’s critical quality attributes and other characteristics. A variety of biophysical techniques, as well as analytical and functional assays, are used to demonstrate comparability.
For more information on our biophysical laboratory services please Contact Us.