USP General Chapter Open for Public Comment

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The chapter is open for comment until Nov. 30, 2019.

USP General Chapter <1108> Assays to Evaluate Fragment Crystallizable (Fc)-Mediated Effector Function is now open for public comment online in the Pharmacopeial Forum 45(5) until Nov. 30, 2019.

The new general chapter was created to give users guidance regarding the selection, development, and validation of Fc function assays, including the measurement of low-affinity interactions observed with Fc gamma receptors (FcγR) and the impact of glycosylation on antibody effector function.

The Fc region plays a key role in regulating the immune system’s responses by modulating the actions of antibodies. FcγR, which are membrane-bound proteins,control and mediate the communication between immunoglobulin antibodies and the immune system, for example, and studies have demonstrated that these specific receptors play multiple roles in conferring immunity against influenza viruses, making them a focus for vaccine development efforts.


The chapter can be accessed for free at

Source: USP