18 Questions
What is the function of excipients in pharmaceuticals?
To affect the bioavailability of drugs
Which of the following is commonly used as a stabilizer in biopharmaceuticals?
Human serum albumin (HSA)
What is the purpose of preservatives in vaccines and drugs?
To prevent microbial growth
What are some factors affecting protein activity in downstream processing?
Physical environment and biological agents
How are protein alterations classified in terms of covalent changes?
Deamidation and oxidation
What is a crucial requirement for clean rooms to control contaminants?
Maintaining air-lock systems
What is the primary purification method in biopharmaceutical purification?
High resolution chromatography
What is the ideal attribute of chromatography resin for biopharmaceutical purification?
Inertness
Which step involves separating molecules based on size and shape using a gel matrix with defined pore sizes?
Gel filtration chromatography
What is the common usage of gel filtration chromatography?
Final 'polishing step' for separation
Which chromatography type offers high capacity, recovery, purification factor, and process control?
Adsorption Chromatography
'Eluate is monitored at 280 nm' refers to which stage in chromatography operation?
Protein elution
Why are preservatives like thimerosal used in vaccines and drugs?
To prevent microbial growth
What are some common biopharmaceutical contaminants mentioned in the text?
Microbes, viruses, DNA, and protein impurities
Why is monitoring of all purification stages essential for quality control in downstream processing?
To prevent contamination and ensure product quality
How can enveloped viruses be inactivated during manufacturing processes?
Through exposure to low pH or solvent-detergent treatment
What is the purpose of final product testing criteria in biopharmaceuticals?
To ensure the product meets end-use dependent criteria
How are viruses generally removed in biopharmaceutical processes?
Through filtration with pore sizes
Test your knowledge on monitoring and quality control in downstream processing, including the validation of sterilization processes and preservatives used in vaccines and drugs. Learn about final product testing and end-use dependent criteria.
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