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BEC 515 Biopharmaceutical Product Characterization Techniques
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.
Prerequisite:颁贬听222 or equivalent
Typically offered in Fall only
Biomanufacturing (Certificate) (For Post-Baccalaureate Students)
/undergraduate/engineering/chemical-biomolecular/biomanufacturing-certificate-post-baccalaureate/
The Certificate in Biomanufacturing provides graduates with the knowledge base and hands-on skills that will prepare them to quickly contribute to a cGMP biomanufacturing operation in significant ways and should reduce the time needed for on-the-job training in those operations.
Biomanufacturing (Certificate)
/undergraduate/engineering/chemical-biomolecular/biomanufacturing-certificate/
The Undergraduate Certificate in Biomanufacturing (鈥淏TEC credential鈥�) is designed for both NC State students and for persons from outside the 福利逼站 who wish to gain hands-on experience with, and understanding of, the technology and operational protocols of large-scale cGMP biomanufacturing operations. This knowledge base will prepare Certificate recipients to quickly contribute to a cGMP biomanufacturing operation in significant ways and should reduce the time needed for on-the-job training in those operations. The Certificate educational focus includes gene expression technologies, bioreactors, downstream separation and purification processes, and aseptic processing operations.