ORISE Fellow US Food and Drug Administration Silver Spring
Presentation Description: Maintaining the quality of biotherapeutics throughout their shelf life and in-use is challenging due to their high sensitivity to formulation excipients, storage conditions and product handling. Here we report an innovative approach using an advanced robotic platform coupled with ion mobility−high resolution mass spectrometry for at-line monitoring both chemical and conformational stability of peptide and proteins. The presentation will first give an overview of the regulatory requirement for biotherapeutics products quality; then use three case studies to highlight FDA/CDER/OPQ/OTR’s regulatory research on: 1) at-line multiple dimensional profiling the isomeric degradation products of a polypeptide; 2) investigation on key instrumental parameters for ion mobility mass spectrometry to minimize artifacts when evaluating high order structure; 3) potential for using collision induced folding (CIU) approaches for comparability of bio-therapeutics products.
Understand the regulatory requirement for biotherapeutics products quality.
Define the chemical and conformational stability of biotherapeutics.
Understand the potential for using collision induced folding (CIU) approaches for comparability of bio-therapeutics products.