This online course presents the fundamentals of biomanufacturing. It focuses on the unit operations utilized to manufacture biological drug products. After an overview of product types, processes, and current Good Manufacturing Practice you’ll address the maintenance of cell lines and growth of cells in a bioreactor. Topics such as mass transfer, process control, and product expression are emphasized. In the second half of the course, lectures focus on downstream unit operations that harvest cells, remove byproducts or contaminants, and fill the final bulk product.
This course was developed in conjunction with the Biomanufacturing Training and Education Center (BTEC) at NC State and SBE.
Topics will include:
- Why and how biopharmaceutical production is regulated
- Typical biomanufacturing flow
- Cryopreservation
- Basics of metabolism and nutrition requirements
- Examples of yield calculations
- Cell growth for industrial production
- Non-suspension cultures
- Solid-liquid separation
- Gravity sedimentation vs. centrifugation
- Centrifuge process and performance parameters
- Chromatography techniques by separation mechanism
- Viral clearance methods
- The ultimate goal of ultrafiltration/diafiltration (UF/DF):
- Protein concentration and buffer exchange
Learning Outcomes:
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Explain how cell lines are maintained and grown in bioreactors to express biomolecules.
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Describe the unit operations required to recover, purify, formulate, and fill bulk biological drug substances.
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Conceptualize processes for the production of biological drug products given a particular cell line and biomolecule.
Who Should Attend:
Any chemical engineer working in a design, operations, or support function within a biopharmaceutical or vaccine company.
Lecture 1: Biomanufacturing Products and Processes
Lecture 2: Cryopreservation and Cell Banking
Lecture 3: Cell Nutrition and Media
Lecture 4: Cell Growth in Production Bioreactors
Lecture 5: Mass Transfer in Bioreactors
Lecture 6: Bioreactor Control Parameters and Process Analytical Technology (PAT)
Lecture 7: Centrifugation and Other Harvest Techniques
Lecture 8: Chromatography Principles and Procedures
Lecture 9: Chromatography Equipment and Performance
Lecture 10: Viral Clearance
Lecture 11: Ultrafiltration and Bulk Filling
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