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Questions and Answers
What is the main method of water removal during freeze-drying?
What is the main method of water removal during freeze-drying?
- Evaporation
- Filtration
- Condensation
- Sublimation (correct)
Which step in the freeze-drying process involves removing water not bound to protein/excipients by sublimation?
Which step in the freeze-drying process involves removing water not bound to protein/excipients by sublimation?
- Thawing step
- Freezing step
- Secondary drying step
- Primary drying step (correct)
At what temperature is the chamber kept during the secondary drying step in freeze-drying?
At what temperature is the chamber kept during the secondary drying step in freeze-drying?
- 5°C
- -5°C
- -20°C
- -40°C (correct)
What happens if a protein solution is freeze-dried without the proper excipients?
What happens if a protein solution is freeze-dried without the proper excipients?
What does Tg refer to in the context of freeze-drying?
What does Tg refer to in the context of freeze-drying?
Which stage of the freeze-drying process involves reducing the pressure and adding heat to allow frozen water in the material to sublimate?
Which stage of the freeze-drying process involves reducing the pressure and adding heat to allow frozen water in the material to sublimate?
What is the purpose of bulking agents in freeze-dried protein formulations?
What is the purpose of bulking agents in freeze-dried protein formulations?
Which excipient is used as a collapse temperature modifier in freeze-dried protein formulations?
Which excipient is used as a collapse temperature modifier in freeze-dried protein formulations?
What is the main reason for the use of lyoprotectants in freeze-dried protein formulations?
What is the main reason for the use of lyoprotectants in freeze-dried protein formulations?
Which mechanism of action do lyoprotectants follow according to the text?
Which mechanism of action do lyoprotectants follow according to the text?
Why is oral delivery of protein drugs preferable despite its low oral bioavailability?
Why is oral delivery of protein drugs preferable despite its low oral bioavailability?
What are the two main reasons for the failure of uptake after oral administration of protein drugs?
What are the two main reasons for the failure of uptake after oral administration of protein drugs?
Which route of administration boasts lower proteolytic activity compared to the GI tract?
Which route of administration boasts lower proteolytic activity compared to the GI tract?
What is a disadvantage of inhaled human insulin compared to subcutaneous routes?
What is a disadvantage of inhaled human insulin compared to subcutaneous routes?
Which route of administration allows for spatial containment of absorption enhancers?
Which route of administration allows for spatial containment of absorption enhancers?
What is a disadvantage of the buccal route of administration?
What is a disadvantage of the buccal route of administration?
Which route allows for the removal of the formulation if necessary?
Which route allows for the removal of the formulation if necessary?
Under what conditions does inhaled human insulin show less reproducibility compared to subcutaneous routes?
Under what conditions does inhaled human insulin show less reproducibility compared to subcutaneous routes?
What is the typical method used to produce monoclonal antibodies?
What is the typical method used to produce monoclonal antibodies?
Which of the following is NOT a component found in parenteral formulations of biotech products?
Which of the following is NOT a component found in parenteral formulations of biotech products?
How can solubility of proteins be enhanced?
How can solubility of proteins be enhanced?
What is lysine or arginine used for in protein solubilization?
What is lysine or arginine used for in protein solubilization?
Which of the following is a function of lyoprotectants/cake formers in biotech formulations?
Which of the following is a function of lyoprotectants/cake formers in biotech formulations?
In what way can the nature of a protein affect the complexity of its formulation?
In what way can the nature of a protein affect the complexity of its formulation?
What is the role of pepsins in the stomach?
What is the role of pepsins in the stomach?
Which pH range is optimal for the activity of pepsins in the stomach?
Which pH range is optimal for the activity of pepsins in the stomach?
What is the main function of exopeptidases like carboxypeptidase A and B?
What is the main function of exopeptidases like carboxypeptidase A and B?
Which enzymes complement each other with different peptide bond cleavage characteristics?
Which enzymes complement each other with different peptide bond cleavage characteristics?
How are proteins further broken down into amino acids, di- or tri-peptides in the GI lumen?
How are proteins further broken down into amino acids, di- or tri-peptides in the GI lumen?
What is the significance of endopeptidases like trypsin, chymotrypsin, and elastase in the GI tract?
What is the significance of endopeptidases like trypsin, chymotrypsin, and elastase in the GI tract?
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