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Downstream Processing Quality Control Quiz

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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?

Physical environment and biological agents Signup and view all the answers

How are protein alterations classified in terms of covalent changes?

Deamidation and oxidation Signup and view all the answers

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

Maintaining air-lock systems Signup and view all the answers

What is the primary purification method in biopharmaceutical purification?

High resolution chromatography Signup and view all the answers

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

Inertness Signup and view all the answers

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

Gel filtration chromatography Signup and view all the answers

What is the common usage of gel filtration chromatography?

Final 'polishing step' for separation Signup and view all the answers

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

Adsorption Chromatography Signup and view all the answers

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

Protein elution Signup and view all the answers

Why are preservatives like thimerosal used in vaccines and drugs?

To prevent microbial growth Signup and view all the answers

What are some common biopharmaceutical contaminants mentioned in the text?

Microbes, viruses, DNA, and protein impurities Signup and view all the answers

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

To prevent contamination and ensure product quality Signup and view all the answers

How can enveloped viruses be inactivated during manufacturing processes?

Through exposure to low pH or solvent-detergent treatment Signup and view all the answers

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

To ensure the product meets end-use dependent criteria Signup and view all the answers

How are viruses generally removed in biopharmaceutical processes?

Through filtration with pore sizes Signup and view all the answers