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Re: biotechinvestor1 post# 6380

Monday, 03/01/2021 5:13:53 PM

Monday, March 01, 2021 5:13:53 PM

Post# of 9129
Good find. Thanks and I hope you are right that approvals will come faster.

Immunogenicity of Protein-based Therapeutics
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Principal Investigator: Zuben E. Sauna, PhD
Office / Division / Lab: OTAT / DPPT / HB

General Overview

A major problem with protein-based therapeutics is their immunogenicity, that is, their tendency to trigger an unwanted immune response against themselves. One form of immune response is activation of B cells, which produce antibodies that bind to the proteins and reduce or eliminate their therapeutic effects. Such antibodies can also cause complications that can be life-threatening. Therefore, a critical part of determining the clinical safety and efficacy of protein-based therapeutic products is measuring their tendency to trigger antibody formation.

https://www.fda.gov/vaccines-blood-biologics/biologics-research-projects/immunogenicity-protein-based-therapeutics
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