Chapter 9.1 Bringing a Biotechnology Product to Market
Study Guide
1. Read through the learning outcomes for chapter 9…focus on these concepts throughout
your reading and lab work in this unit.
9.1 Intro to biomanufacturing:
2. What does biomanufacturing mean in your own words?
3. Define in your own words these terms which are used in the last paragraph on page 253:
transformed cells:
transfected cells:
native cells:
4. List the 5 basic steps in biomanufacturing (pg 254).
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5. What is a bioreactor?
6. Describe what it means to “scale-up.”
(pg 254 & For this you will need to also read pages235-6 in chapter 8)
7. Draw your own diagram of the scale-up process similar to figure 8.20.
(Please do not copy and paste for this).
Downstream Manufacturing: Recovery and Purification:
8. Define intracellular and extracellular proteins (own words):
9. Using amylase as an example, explain how an extra cellular protein can be isolated. (pg. 255)
10. Explain what is more challenging about purifying intracellular proteins versus extracellular proteins?
11. When harvesting broth cultures, the cells must be separated from the broth…
What are the steps involved? (pg 255)
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12. Once the cells have been separated, the broth still contains multiple proteins. In column
chromatography, what is accomplishing the separation of the molecules which allows an
individual protein to be purified?
13. Read about the different types of chromatography (pg. 256) we’ll go into depth on this in 9.2.
14. Reading on page 257, and using diagram 9.7 on page 258….summarize the differences in the
objectives of the upstream and downstream processes during biomanufacturing.
15. Go online and find 2 contract biomanufacturing companies; this is a “hot” area in
business biotech. What is the name of each of the companies you found? & for each,
describe the services this company offers or what it specializes in.
16. Do the Biotech Live Activity 9.2 on page 277.
Homework: Read and outline 9.2 (chapter 9 section 2 pages 259-264.