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Weekly Reflection

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This week, we have learnt types of immune response and immunity; factors that influence antibody formation of therapeutic proteins; structure factor of immunogenicity; clinical effects of induced antibodies; immunogenicity; and strategies to reduce immunogenicity.

Here are some key points for you to review what you have learnt this week. There is no need to answer them all. You could use these to check the gist of this week.

  1. Illustrate the difference between immunity, immunogenicity, and autoimmune response with known examples.

  2. Summarize the factors that influence antibody formation of therapeutic proteins, to include source, structure, formulation, impurities, among others.

  3. What are the two most commonly used biochemical procedures to decrease turn over, prolong half-life, reduce frequency of dosing and improve efficacy of therapeutic proteins? Give example biologics that benefit from such chemical manipulations.

  4. Discuss the elements for the evaluation of clinical immunogenicity, including clinical study in treatment naïve patients, ADA incidence and titer, onset of ADA, duration of ADA, and impact of ADA on clinical efficacy, clinical safety and other clinically relevant outcomes. Note ADA=anti-drug antibody.

  5. Elaborate on the potential clinical effects of induced antibodies, be it a neutralizing antibody or binding antibody. Is immunogenic response always harmful or could be beneficial?

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Pharmacotherapy: Understanding Biotechnology Products

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