Module 4 - In Depth Analytical ChallengesUpon completion of this fourth module, the learner should be able to:
- describe the basic modular structure of different types of non-antibody based protein scaffolds;
- explain the overview of immunogenicity assessment strategies and risks for non-antibody based protein scaffolds;
- describe immunogenicity risk factors relevant and specific to multi-domain biotherapeutics;
- 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;
- describe the challenges of protein drug delivery;
- evaluate PEGylation as a parenteral time-action strategy and impact on PK/PD;
- list advantages of PEGylating a therapeutic protein;
- describe the consequences of anti-PEG antibodies in humans;
- identify industry approaches for identifying and reporting pre-existing antibodies;
- describe the frequency of pre-existing antibodies with respect to biotherapeutic type and disease area; and
- discuss the impact of pre-existing antibodies on immunogenicity, patient safety and product efficacy.
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