Biomanufacturing Primer

Biomanufacturing Primer

Biomanufacturing Primer


*This microcourse includes optional CPE Credits and is powered by Biotech Primer, a trusted leader in life science training that simplifies complex topics for non-scientists.


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Optional CPE Credit: 1.0


Overview:

Biomanufacturing Primer introduces the ever-evolving world of biomanufacturing. It gives a scientific overview of essential topics such as the intricacies driving cell lines, cell banks, upstream/downstream bioprocessing, and the latest advancements in this dynamic field. The class compares the fascinating differences between bacterial and mammalian cell lines and explains which drug products each can and cannot produce. The concept of cell banks, both master and working cell banks, and their critical manufacturing roles are explained in detail. This primer outlines the art of upstream bioprocessing (optimizing cell growth and scale-up) and downstream bioprocessing (harvesting and purifying protein drug products). The class ends by highlighting incredible advancements such as continuous bioprocessing, single-use technologies, and critical quality attributes.

  • Section 1: Cell Lines: Explains cell line development and the process of cell bank production.
  • Section 2: Cell Banks: Discusses in detail the steps used to make biologics, specifically bulk upstream and bulk downstream processing.
  • Section 3: Upstream Bioprocessing: Highlights the nuances involved in harvesting and purifying a therapeutic protein from cell culture and explains the testing protocols that ensure drug product quality.
  • Session 4: Downstream Bioprocessing: Explores some of the new technologies that companies are using to reduce costs and increase yield of the drug product. These include continuous bioprocessing, continuous chromatography, and single-use systems.
  • Session 5: Advancements in Biomanufacturing: Learn the benefits and risks of continuous bioprocessing and single-use technologies.


By the end of the course, participants will be able to:

  1. Explain the process of bacterial and mammalian cell line development. 
  2. Compare the roles of a master cell bank and the working cell bank. 
  3. Describe, in detail, the steps of upstream and downstream bioprocessing and how to optimize cell growth for maximum productivity. 
  4. Discuss the highly regulated testing protocols that ensure product quality. 
  5. Cite the benefits and risks of game-changing advancements in biomanufacturing, including continuous bioprocessing and single-use technologies.

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