BIOT 251 - Techniques of Biomanufacturing

(G only)

Introduction to the process of producing a biological product using a cell line. The course will be organized as a production campaign in a simulated cGMP environment. Students will complete a batch record as they produce a biological product. Emphasis will be on upstream and downstream processes. Preparation of media and buffers. The upstream component begins with a vial thaw and flask seeding. Closed system scale-up from a shake flask to a 3-liter closed system single use bioreactor. Probe assembly and calibration. TFF separation of proteins. Use of FPLC protein purification systems including associated software. SDS-PAGE analysis of the purified protein. PREREQUISITE(S): BIOT 121 and BIOT 201. PRE- or COREQUISITE(S): BIOT 250 or consent of department. Three hours laboratory each week.

1 semester hour

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

Understand and apply the basics of cGMP biologics manufacturing including following SOPs and completing a batch record.
Assemble and work with a closed system for transfer of media and cells, sampling by using a sterile tubing welder and peristaltic pump in a bioreactor.
Assemble and run a single use stirred tank bioreactor using insect or mammalian cells including probe (pH and DO) assembly and calibration.
Set up and run an FPLC for protein purification.
Perform tangential flow filtration at the bench scale.
Complete calculations associated with the processes described above.

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