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【求助】如何在USP上查找抗体药物相关质量标准
如题。【求助】如何在USP上查找抗体药物相关质量标准
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.]
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【求助】如何在USP上查找抗体药物相关质量标准
【求助】如何在USP上查找抗体药物相关质量标准
1260-TOC-300x225.png
最新回复
eric930 (2016-4-10 17:39:54)
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.
Genentech Technical Regulatory Policy and Strategy Director Earl Dye provided an update on the USP MAb effort at the RAPS annual meeting in Indianapolis, Indiana in late October, referencing a report by Mire-Sluis at the USP Science and Standards Symposium in Seattle, Washington a few weeks earlier.
eric930 (2016-4-10 17:40:20)
Chapter <129> will hone in on quality attributes common to monoclonal antibodies and details of the tests used to measure the attributes. Included will be the minimum quality standards required for all monoclonal antibodies, how to identify appropriate quality attributes, and details such as analytical procedure and system suitability requirements for doing those kinds of assessments.
According to Mire-Sluis, <129> is designed to be “flexible” in its approach in terms of determining quality attributes to assure the minimum level of quality.
eric930 (2016-4-10 17:41:01)
Product-class-standards-slide-300x225.png
eric930 (2016-4-10 17:43:04)
The authoring team feels that a flexible approach is needed due to the unique quality attributes of each MAb, such as: ● the ligand it binds to ● the potential for effector function ● differing glycosylation patterns, and ● the nature and extent of N- and C-terminal heterogeneity.
Included in the scope of <129> are chimeric human or humanized IgG isolates and subtypes. It will apply to monoclonal antibodies for therapeutic and prophylactic use and for use in in vivo diagnostics. It will not apply to MAbs that are used as reagents in the manufacture of medicinal products, nor to MAb products produced in ascites, for which requirements are decided by the competent authorities
eric930 (2016-4-10 17:50:55)
cuturl('http://www.usp.org/sites/default/files/usp_pdf/ZH/press_release/fy1152_medicines_compendium_press_release_zh.pdf')
重新上传一下,如果有些人看不到链接
66+77 (2016-4-10 17:51:26)
memory (2016-4-10 17:52:32)
qumm1985 (2016-4-10 17:53:29)
看来是真的查不到,我也查过
eric930 (2016-4-10 17:54:08)
ukonptp (2016-4-10 17:55:11)
现在在USP-MC里面有利妥昔的质量标准了:
cuturl('https://mc.usp.org/monographs/rituximab-1-0')
qqq111 (2016-4-10 17:55:28)
qqq111 (2016-4-10 17:56:43)
找到的2个。
分别是Rituximabl利妥昔单抗和Trastuzumab曲妥珠单抗
duoduo (2016-4-10 17:57:10)
Avastin的也有
cuturl('https://mc.usp.org/monographs/bevacizumab-0-2')
october7 (2016-4-10 17:57:35)
咦,难道专利到期了,为什么把这些质量标准公布出来呢,还包括氨基酸序列?
难道是在说,我不怕你们仿?
owanaka (2016-4-10 17:58:32)
eric930 (2016-4-10 17:59:06)
QUOTE:
补充下,不是所有的FDA批准上市的单抗都能查到。#碧海潮生# (2016-4-10 18:00:33)
#碧海潮生# (2016-4-10 18:03:31)
yayya (2016-4-10 18:04:01)
MC网站已经打不开了。。。
【求助】如何在USP上查找抗体药物相关质量标准