The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk‐based management for their control
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چکیده
منابع مشابه
The future of host cell protein (HCP) identification during process development and manufacturing linked to a risk‐based management for their control
The use of biological systems to synthesize complex therapeutic products has been a remarkable success. However, during product development, great attention must be devoted to defining acceptable levels of impurities that derive from that biological system, heading this list are host cell proteins (HCPs). Recent advances in proteomic analytics have shown how diverse this class of impurities is;...
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ژورنال
عنوان ژورنال: Biotechnology and Bioengineering
سال: 2015
ISSN: 0006-3592,1097-0290
DOI: 10.1002/bit.25628