Engineered therapeutic proteins, monoclonal antibodies (MAbs) as well as bispecific monoclonal antibodies (BsMAbs), genes or genetic sequences (e.g. mRNAs, oligonucleotides), and cell and engineered cell based therapeutics (e.g. stem cell, CAR-T-cells) have demonstrated the successful delivery of breakthrough therapies for many unmet medical needs. The enthusiasm continues to increase the pipelines of the pharmaceutical industry in their efforts to address the medical conditions for which no effective treatment currently exists. While immunological reactions are utilized in effective vaccine development as demonstrated recently by the introduction of a new generation of mRNA vaccines against SARS CoV2 in record time, undesired immunological reactions to engineered therapeutic biopharmaceutical compounds are a threat. Throughout the development of therapeutic biologic compounds, undesired immunogenicity remains one of the most important risk factors for patient safety. The FDA made it clear that it will not compromise on patient safety in clinical trials for the development of therapies even vaccines for the SARS-CoV2 virus, stating “Ensuring the safety of trial participants is paramount”
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