USP has set an aggressive goal of April, 2012 to complete drafts of a mandatory general chapter (<129>) covering critical quality attributes (CQAs) of recombinant therapeutic monoclonal antibodies (MAbs) and an informational general chapter (<1260>) addressing a broader range of monoclonal manufacturing and control issues.
The expert panel overseeing the drafting of the two new MAb chapters was formed in January under the direction of Amgen Global Product Quality and External Affairs Executive Director Anthony Mire-Sluis, who has created a number of subcommittees that are working on various portions of the two documents.
[More on the new drafts from updates provided at recent USP and RAPS meetings are provided for subscribers here. Nonsubscribers can purchase the story for $95 by contacting Jonathan Trethowan (Jonathan@ipq.org). For subscription/license information, click here.]