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Module 4 - In Depth Analytical Challenges

Module 4 - In Depth Analytical Challenges

Upon completion of this fourth module, the learner should be able to:
  1. describe the basic modular structure of different types of non-antibody based protein scaffolds;
  2. explain the overview of immunogenicity assessment strategies and risks for non-antibody based protein scaffolds;
  3. describe immunogenicity risk factors relevant and specific to multi-domain biotherapeutics;
  4. discuss assessment strategies for characterization of immune responses to MDBs;
    • discuss selection of suitable assay platform for non-mAb therapeutics;
    • identify ways to optimize assay, validation and support assay life-cycle management for long term use;
  5. describe the challenges of protein drug delivery;
  6. evaluate PEGylation as a parenteral time-action strategy and impact on PK/PD;
  7. list advantages of PEGylating a therapeutic protein;
  8. describe the consequences of anti-PEG antibodies in humans;
  9. identify industry approaches for identifying and reporting pre-existing antibodies;
  10. describe the frequency of pre-existing antibodies with respect to biotherapeutic type and disease area; and
  11. discuss the impact of pre-existing antibodies on immunogenicity, patient safety and product efficacy.


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