Downstream Processing - Unsolved Practice Set
Chapter: Biotechnology Principles and Processes | Topic: Downstream Processing
DOWNSTREAM PROCESSING - UNSOLVED PRACTICE SET
Topic: Downstream Processing
Multiple Choice Questions
Q1. Downstream processing refers to the series of processes carried out:
- Before the biosynthesis of a product begins
- After the biosynthesis stage, to separate and purify the desired product
- Only during the transformation step
- Only during PCR amplification
Q2. One of the main purposes of downstream processing is to:
- Introduce foreign DNA into a host cell
- Separate and purify the desired product from the culture medium and other unwanted materials
- Cut DNA at specific recognition sites
- Amplify a specific DNA sequence
Q3. Before a biotechnologically produced pharmaceutical product can be marketed, it typically must undergo:
- No further testing at all
- Rigorous quality control testing to ensure safety and efficacy
- Only visual inspection
- Testing only for colour and packaging
Q4. Formulation, as part of downstream processing, generally involves:
- Only separating the product from the culture broth
- Adding suitable preservatives and preparing the product in a form suitable for its intended use
- Cutting the DNA of the host organism
- Introducing the vector into a new host cell
Q5. Downstream processing is considered an essential part of the biotechnology production process mainly because:
- It has no real impact on the final product
- It ensures that the final product is sufficiently pure, safe, and suitable for its intended use before reaching the market
- It replaces the need for a bioreactor entirely
- It occurs before any biosynthesis takes place
Short Answer Questions
Q6. Define downstream processing, and explain when it occurs in relation to the biosynthesis stage.
Q7. Why is separation and purification of the product considered a critical part of downstream processing?
Q8. What is meant by "formulation" in the context of downstream processing?
Q9. Why must biotechnologically produced pharmaceutical products undergo rigorous quality control testing before being marketed?
Long Answer Questions
Q10. Discuss the general steps involved in downstream processing, explaining why each step is necessary to obtain a safe, pure, and market-ready product.
Q11. Explain the overall importance of downstream processing in the biotechnology production pipeline, using a suitable example such as the production of a pharmaceutical product.
APPLICATION / ANALYSIS
Q12. A biotechnology company successfully produces a therapeutic protein inside genetically modified bacterial cells, but the protein is still mixed with bacterial cell debris and culture medium components. Explain, using your understanding of downstream processing, what steps the company would need to take before this protein could be safely used as a medicine.
Q13. A batch of biotechnologically produced insulin fails a quality control test during downstream processing due to the presence of impurities. Explain why it is important that this batch is not released to the market, despite the time and resources already invested in its production.