Type of Posting: Notice of Intent to Revise
Posting Date: 05-Feb-2021
Targeted Official Date: TBD- Interim Revision Announcement
Expert Committee: Biologics Monographs 5 – Advanced Therapies
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monographs 5 – Advanced Therapies Expert Committee intends to revise the <90> Fetal Bovine Serum Quality Attributes and Functionality Tests.
Comments were received that indicate that some of the critical reagents needed to perform the Identification test are not available, and the test cannot be performed as described. The Expert Committee proposes to revise the USP chapter, <90> Fetal Bovine Serum Quality Attributes and Functionality Tests to remove the Radial Immunodiffusion test and replace it with a different method for Identification.
It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in a future Pharmacopeial Forum pursuant to the Rules and Procedures once the laboratory work is complete.
Should you have any questions, please contact Rebecca Potts, Associate Scientific Liaison (rcp@usp.org).
CN-21-036-00