Biopharmaceutical Product Characterization Techniques

Catalog description

This 8 week graduate course introduces engineering students to bioanalytical testing to processes that produce structurally complex biopharmaceuticals. Students will gain hands-on experience including assay validation, drug/biologic substance characterization (structural and activity) and biopharmaceutical purity. The technologies and related theory will include rapid micro SDS-PAGE, lab-on-a-chip, HPLC, mass spectrometry, UV/Vis absorbance and fluorescence spectroscopy. Students will also learn assay development and validation concepts as per ICH Q2(R1) and other U.S. and international government regulatory guidelines.