Failure Mode and Effects Analysis (FMEA) for Immunogenicity of Therapeutic Proteins.

Biotherapeutic drugs made by cell-based systems are revolutionizing the practice of medicine. The next generation of biotherapeutics include recombinant proteins, monoclonal antibodies, viral vector expressed proteins, and cell therapies. Immunogenicity associated adverse events is one of the major risks for these biologics. Accurate and precise measurement of the immunogenicity of biologics is a critical component during all phases of drug development. We have utilized the principles of Failure Mode and Effects Analysis (FMEA) in performing assessment of risk of immunogenicity. The multi-dimensional approach involves: i) listing all the potential risks by likelihood of occurrence and severity as part of quality target product profile. ii) ascribing the causes by identifying the risks at each stage of development. iii) predicting the effects. iv) determining the risk mitigation strategy. v) implementing a monitoring process. vi) developing templates for data collection. vii) timely reporting and. viii) life cycle management. FMEA is a continuous process that works throughout the lifecycle of the product or the process and keeps on getting updated with new insights and knowledge.

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