Downstream Processing Quality Control Quiz
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Questions and Answers

What is the function of excipients in pharmaceuticals?

  • To prevent microbial growth
  • To stabilize proteins
  • To maintain clean room temperature
  • To affect the bioavailability of drugs (correct)

Which of the following is commonly used as a stabilizer in biopharmaceuticals?

  • Surfactants
  • Polyhydric alcohols
  • Amino acids
  • Human serum albumin (HSA) (correct)

What is the purpose of preservatives in vaccines and drugs?

  • To maintain specific temperature ranges
  • To affect the bioavailability of drugs
  • To prevent microbial growth (correct)
  • To stabilize proteins

What are some factors affecting protein activity in downstream processing?

<p>Physical environment and biological agents (D)</p> Signup and view all the answers

How are protein alterations classified in terms of covalent changes?

<p>Deamidation and oxidation (C)</p> Signup and view all the answers

What is a crucial requirement for clean rooms to control contaminants?

<p>Maintaining air-lock systems (A)</p> Signup and view all the answers

What is the primary purification method in biopharmaceutical purification?

<p>High resolution chromatography (C)</p> Signup and view all the answers

What is the ideal attribute of chromatography resin for biopharmaceutical purification?

<p>Inertness (A)</p> Signup and view all the answers

Which step involves separating molecules based on size and shape using a gel matrix with defined pore sizes?

<p>Gel filtration chromatography (D)</p> Signup and view all the answers

What is the common usage of gel filtration chromatography?

<p>Final 'polishing step' for separation (B)</p> Signup and view all the answers

Which chromatography type offers high capacity, recovery, purification factor, and process control?

<p>Adsorption Chromatography (D)</p> Signup and view all the answers

'Eluate is monitored at 280 nm' refers to which stage in chromatography operation?

<p>Protein elution (A)</p> Signup and view all the answers

Why are preservatives like thimerosal used in vaccines and drugs?

<p>To prevent microbial growth (C)</p> Signup and view all the answers

What are some common biopharmaceutical contaminants mentioned in the text?

<p>Microbes, viruses, DNA, and protein impurities (B)</p> Signup and view all the answers

Why is monitoring of all purification stages essential for quality control in downstream processing?

<p>To prevent contamination and ensure product quality (A)</p> Signup and view all the answers

How can enveloped viruses be inactivated during manufacturing processes?

<p>Through exposure to low pH or solvent-detergent treatment (C)</p> Signup and view all the answers

What is the purpose of final product testing criteria in biopharmaceuticals?

<p>To ensure the product meets end-use dependent criteria (C)</p> Signup and view all the answers

How are viruses generally removed in biopharmaceutical processes?

<p>Through filtration with pore sizes (A)</p> Signup and view all the answers

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