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Assignment 1
EnE 215 – Biochemical Engineering
First Semester SY 2022-23
Assignment Guidelines
Topic 1
None applicable
Topic 2
1. What is GMP and how does it relate to the regulatory process for pharmaceuticals?
2. When the FDA approves a process, it requires validation of the process. Explain what validation
means in the FDA context.
3. Why does the FDA approve the process and product together?
Topic 3
1. You wish to produce a high-value protein using recombinant DNA technology. Would you try to
develop a chemical defined medium or a complex medium? Why?
2. Contrast DNA and RNA. Cite at least four differences.
3. Contrast the advantages and disadvantages of chemically defined and complex media.
Topic 4
k1 k3
S+ E ⇌ (ES)1 ⇌ (ES)2 k 5 P+ E
→
k2 k4