BIOT 261 - 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. PREREQUISITE(S): BIOT 121, BIOT 201, BIOT 241. PRE- or COREQUISITE(S): BIOT 260. Three hours laboratory each week.

1 semester hour

Course Outcomes:
Upon completion of this course, a student will be able to:

Follow SOPs and demonstrate GDP.
Demonstrate proper gowning and aseptic techniques.
Scale up or scale out the production of cells relevant to gene and cell therapies.
Purify viral vectors and plasmids.
Transfect host cells with a vector.
Use a FACS.
Use qPCR, ELISA, and other assays to assess the quality.
Complete basic calculations critical to gene and therapy process.

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