Freeze-Drying Protein Products Excipients Quiz
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Questions and Answers

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?

  • 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?

  • 5°C
  • -5°C
  • -20°C
  • -40°C (correct)
  • What happens if a protein solution is freeze-dried without the proper excipients?

    <p>It results in irreversible damage to the protein (A)</p> Signup and view all the answers

    What does Tg refer to in the context of freeze-drying?

    <p>Glass transition temperature (C)</p> Signup and view all the answers

    Which stage of the freeze-drying process involves reducing the pressure and adding heat to allow frozen water in the material to sublimate?

    <p>Primary drying step (B)</p> Signup and view all the answers

    What is the purpose of bulking agents in freeze-dried protein formulations?

    <p>Prevent blowout by adding solid material to the vial (D)</p> Signup and view all the answers

    Which excipient is used as a collapse temperature modifier in freeze-dried protein formulations?

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

    What is the main reason for the use of lyoprotectants in freeze-dried protein formulations?

    <p>Replace water as a stabilizing agent (B)</p> Signup and view all the answers

    Which mechanism of action do lyoprotectants follow according to the text?

    <p>Replace water as a stabilizing agent (B)</p> Signup and view all the answers

    Why is oral delivery of protein drugs preferable despite its low oral bioavailability?

    <p>It doesn't require intervention by a healthcare professional (C)</p> Signup and view all the answers

    What are the two main reasons for the failure of uptake after oral administration of protein drugs?

    <p>Low oral bioavailability and lack of intervention by a healthcare professional (B)</p> Signup and view all the answers

    Which route of administration boasts lower proteolytic activity compared to the GI tract?

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

    What is a disadvantage of inhaled human insulin compared to subcutaneous routes?

    <p>Increased immunogenicity (D)</p> Signup and view all the answers

    Which route of administration allows for spatial containment of absorption enhancers?

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

    What is a disadvantage of the buccal route of administration?

    <p>Low bioavailability for proteins (A)</p> Signup and view all the answers

    Which route allows for the removal of the formulation if necessary?

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

    Under what conditions does inhaled human insulin show less reproducibility compared to subcutaneous routes?

    <p>Pathological conditions (D)</p> Signup and view all the answers

    What is the typical method used to produce monoclonal antibodies?

    <p>Fusing myeloma cells with the spleen from an immunized mouse (C)</p> Signup and view all the answers

    Which of the following is NOT a component found in parenteral formulations of biotech products?

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

    How can solubility of proteins be enhanced?

    <p>Increasing pH and ionic strength conditions (D)</p> Signup and view all the answers

    What is lysine or arginine used for in protein solubilization?

    <p>Enhance solubility (B)</p> Signup and view all the answers

    Which of the following is a function of lyoprotectants/cake formers in biotech formulations?

    <p>Prevent aggregation (B)</p> Signup and view all the answers

    In what way can the nature of a protein affect the complexity of its formulation?

    <p>By requiring specific excipients for stability (A)</p> Signup and view all the answers

    What is the role of pepsins in the stomach?

    <p>Breaking down proteins into amino acids and di- or tri-peptides (D)</p> Signup and view all the answers

    Which pH range is optimal for the activity of pepsins in the stomach?

    <p>3-5 (D)</p> Signup and view all the answers

    What is the main function of exopeptidases like carboxypeptidase A and B?

    <p>Degrading peptide chains from their ends (C)</p> Signup and view all the answers

    Which enzymes complement each other with different peptide bond cleavage characteristics?

    <p>Chymotrypsin and elastase (D)</p> Signup and view all the answers

    How are proteins further broken down into amino acids, di- or tri-peptides in the GI lumen?

    <p>By brush border and cytoplasmic proteases of enterocytes (A)</p> Signup and view all the answers

    What is the significance of endopeptidases like trypsin, chymotrypsin, and elastase in the GI tract?

    <p>Breaking down proteins into amino acids and di- or tri-peptides (C)</p> Signup and view all the answers

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