Abstract
Biophysical techniques such as analytical ultracentrifugation (AUC), circular dichroism (CD), and differential scanning calorimetry (DSC) have been widely used by the biopharmaceutical industry to study higher-order structure of protein therapeutics. The data generated have generally been included in regulatory filings as part of the elucidation of structure and other characteristics and pharmaceutical development. In recent years, there is increasing scrutiny from the regulatory agencies on the qualification of these techniques. This chapter provides an overview of the biophysical methods used for generating information for regulatory filings during protein therapeutics development, purposes of these analyses, qualification approaches of these methods, any gaps present, and future directions.
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a callDisclaimer: All third-party content on this website/platform is and will remain the property of their respective owners and is provided on "as is" basis without any warranties, express or implied. Use of third-party content does not indicate any affiliation, sponsorship with or endorsement by them. Any references to third-party content is to identify the corresponding services and shall be considered fair use under The CopyrightLaw.
