Type of Posting: Notice of Intent to Revise
Posting Date: 27–Sep–2019
Targeted Official Date: 01–Aug–2021, USP 2021, Edition 2
Expert Committee: Biologics Monographs 2-Proteins
In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monographs 2-Proteins Expert Committee intends to omit General Chapter <130> Protein A Quality Attributes.
Biologics Monographs 2-Proteins EC has determined that General Chapter <130> Protein A Quality Attributes does not meet the current needs of stakeholders. Therefore, USP the Committee has determined that this chapter should be proposed for omission in the Pharmacopeial Forum (PF).
In addition, USP plans to discontinue the reference standards (USP Protein A RS, USP rProtein A C-Cys RS, rProtein A, B4, C-Cys RS) associated with the chapter.
It is anticipated that the proposed omission will be published in PF 46(2) [Nov–Dec. 2019].
Should you have any questions, please contact Krishna Menon, Senior Scientific Liaison (firstname.lastname@example.org).