小中大【求助】如何在USP上查找抗体药物相关质量标准
如题。
小弟查了光盘阅览室的USP35,居然一个抗体药物的monograph没有,通则也没有。
Google 查到了一个信息《1260》cuturl('http://www.ipqpubs.com/usp-mab-2012/')
USP MAb General Chapters on Fast Track
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.
[The rest of the story that follows is normally only available to IPQ subscribers. By special arrangement between IPQ and PharmaQbD, the complete story is being made available.
Click to Enlarge
MAb chapter <129> is one of a series that USP will be developing on quality attributes for different types of biologic/biotech products, including enzymes, vaccines and peptides. The development of the quality attribute chapters including <129> is called for in the work plan for the current USP five-year cycle (2010-2015). The effort on <1260> continues an initiative begun under the previous cycle.
The subcommittee on general chapter <1260> – an overarching chapter that provides general guidance about various aspects of MAb structure and function – is being chaired by OncoMed Process Development VP Michael Mulkerrin, who also chairs the Biologics and Biotechnology Expert Committee.
The chapter will provide manufacturers with guidance on: ● how to develop a monoclonal antibody ● what critical information is needed to define quality attributes ● how to create expression vectors and manufacturing processes that are associated with the downstream purification, formulation and filling of those products, and ● attributes of the facilities that MAbs are made in. Other sections will deal with monoclonal regulatory and post-approval issues
[ 本帖最后由 summerxx 于 2014-8-7 15:13 编辑 ]