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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 (...
| Autores principales: | , , |
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| Formato: | Online Artículo Texto |
| Lenguaje: | English |
| Publicado: |
John Wiley and Sons Inc.
2015
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| Materias: | |
| Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4973824/ https://www.ncbi.nlm.nih.gov/pubmed/25998019 http://dx.doi.org/10.1002/bit.25628 |