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MASS SPECTROMETRY-BASED METHOD FOR IDENTIFYING AND MAINTAINING QUALITY CONTROL FACTORS DURING THE DEVELOPMENT AND MANUFACTURE OF A BIOLOGIC
专利权人:
Bioanalytix; Inc.
发明人:
LI, Lily, T.,POSS, Kirtland, G.,GARNICK, Robert,WU, Shiaw-Lin
申请号:
EP14851186
公开号:
EP3114476A4
申请日:
2014.10.03
申请国别(地区):
EP
年份:
2017
代理人:
摘要:
The invention provides methods for determining a set of critical features that serves as a “map” of attributes critical for maintaining the structure and function of a biologic. The map can serve as a development tool, e.g., as a guide or target during the development of expression, purification, and formulation protocols, a quality assurance tool during manufacturing, or as a definitive identifier of the specific biologic. The map can also serve as the definition of the biologic thereby providing a means by which a given product may be reliably characterized as a biosimilar of another biologic product.
来源网站:
中国工程科技知识中心
来源网址:
http://www.ckcest.cn/home/

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