Introduction to Biomanufacturing

Module 1

• Recognize when aseptic technique is required
• Describe basics of airflow and HEPA filtration in BSCs
• Explain the difference between disinfectant and sanitizer
• Explain the main principles for proper aseptic technique: product contact surface and first air rule
• Demonstrate the ability to maintain sterility
• Judge the effectiveness of the technique or other worker’s technique
• Describe different types of media
• For mammalian cell culture, describe serum free versus serum-containing media
• Prepare media using written instructions

Module 2

• Describe the Lac operon system
• Design a strategy to express a protein using a lac operon containing plasmid

Module 3

• Define the growth rate formula
• Interpret rate based on supplied data
• Understand cell banks and their types

Module 4

• Identify parts of fermentor/bioreactor
• Apply knowledge to setup the system
• Explain how the parts fit with the overall process
• Describe the difference between microbial and mammalian cell processes
• Describe components needed for fermentation
• Explain what a control loop is

Module 5

• Compare and Contrast batch v. fed-batch
• Design a feed strategy
• Describe how a CIP and SIP systems works
• Distinguish between SIP and autoclavable systems

Module 6

• Understand Vaccine Technology
• Understand Gene Therapy
• Understand Antibody Technology including drug conjugates and bispecific antibodies
• Single Use systems
• Other production systems CHO/HEK
• Viral vaccine production concepts using mammalian host cells
• Other platforms such as adherent cells on microcarriers

Module 7

• Describe cell homogenization and sonication
• Compare and contrast chemical and mechanical homogenization techniques

Module 8

• Explain Dead End Filtration and Depth Filtration
• Compare and Contrast Dead End Filtration and Depth Filtration
• Design a strategy to filter different materials

Module 9

• Explain affinity chromatography and types
• Compare and Contrast affinity versus other types of chromatography

Module 10

• Explain Ion Exchange Chromatography
• Compare and contrast IEX to Size exclusion and hydrophobic interactions chromatography
• Create a strategy for Ion Exchange chromatography

Module 11

• Define TFF
• Calculate Flux rates and compare to TMP
• Design strategy to UF/DF a protein
• Compare and contrast microfiltration and ultrafiltration

Module 12

• Explain the importance of protein analytics
• Compare and Contrast SDS-PAGE and Spectrophotometry for analysis of a protein sample
• Assess a sample for protein purity
• Understand how ELISA is used for protein characterization