30 Questions
What is the main method of water removal during freeze-drying?
Sublimation
Which step in the freeze-drying process involves removing water not bound to protein/excipients by sublimation?
Primary drying step
At what temperature is the chamber kept during the secondary drying step in freeze-drying?
-40°C
What happens if a protein solution is freeze-dried without the proper excipients?
It results in irreversible damage to the protein
What does Tg refer to in the context of freeze-drying?
Glass transition temperature
Which stage of the freeze-drying process involves reducing the pressure and adding heat to allow frozen water in the material to sublimate?
Primary drying step
What is the purpose of bulking agents in freeze-dried protein formulations?
Prevent blowout by adding solid material to the vial
Which excipient is used as a collapse temperature modifier in freeze-dried protein formulations?
Dextran
What is the main reason for the use of lyoprotectants in freeze-dried protein formulations?
Replace water as a stabilizing agent
Which mechanism of action do lyoprotectants follow according to the text?
Replace water as a stabilizing agent
Why is oral delivery of protein drugs preferable despite its low oral bioavailability?
It doesn't require intervention by a healthcare professional
What are the two main reasons for the failure of uptake after oral administration of protein drugs?
Low oral bioavailability and lack of intervention by a healthcare professional
Which route of administration boasts lower proteolytic activity compared to the GI tract?
Buccal
What is a disadvantage of inhaled human insulin compared to subcutaneous routes?
Increased immunogenicity
Which route of administration allows for spatial containment of absorption enhancers?
Rectal
What is a disadvantage of the buccal route of administration?
Low bioavailability for proteins
Which route allows for the removal of the formulation if necessary?
Transdermal
Under what conditions does inhaled human insulin show less reproducibility compared to subcutaneous routes?
Pathological conditions
What is the typical method used to produce monoclonal antibodies?
Fusing myeloma cells with the spleen from an immunized mouse
Which of the following is NOT a component found in parenteral formulations of biotech products?
Antibiotics
How can solubility of proteins be enhanced?
Increasing pH and ionic strength conditions
What is lysine or arginine used for in protein solubilization?
Enhance solubility
Which of the following is a function of lyoprotectants/cake formers in biotech formulations?
Prevent aggregation
In what way can the nature of a protein affect the complexity of its formulation?
By requiring specific excipients for stability
What is the role of pepsins in the stomach?
Breaking down proteins into amino acids and di- or tri-peptides
Which pH range is optimal for the activity of pepsins in the stomach?
3-5
What is the main function of exopeptidases like carboxypeptidase A and B?
Degrading peptide chains from their ends
Which enzymes complement each other with different peptide bond cleavage characteristics?
Chymotrypsin and elastase
How are proteins further broken down into amino acids, di- or tri-peptides in the GI lumen?
By brush border and cytoplasmic proteases of enterocytes
What is the significance of endopeptidases like trypsin, chymotrypsin, and elastase in the GI tract?
Breaking down proteins into amino acids and di- or tri-peptides
Test your knowledge on excipients commonly used in freeze-drying protein products, including bulking agents and collapse temperature modifiers. Learn about the reasons for using specific excipients to prevent issues like blowout and increase collapse temperature.
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