BIOT261 — Laboratory Fundamentals for Cell and Gene Therapy Production
(G only) Hands-on introduction to the essential methods used in the production of gene and cell therapies. Understanding of BSL levels and safety considerations. Basic cGMP with an emphasis on aseptic technique and GDP. Plasmid and vector production (bioreactor) in producer cells, plasmid and vector purification, characterization of vectors. Scale up and scale out of cells in bioreactors. Quality control assays including qPCR, ELISA, and rapid sterility testing. Lab math is associated with cell and gene therapy such as the determination of multiplicity of infection, cell concentration at infection, and vector genomes. PRE- or Three hours laboratory each week. 1 semester hour Course
Prerequisites: BIOT121, BIOT201, BIOT241