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Host cell proteins in biotechnology‐derived products: A risk assessment framework |
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| Authors: | Christina L. Zuch de Zafra Valerie Quarmby Kathleen Francissen Martin Vanderlaan Judith Zhu‐Shimoni |
| Affiliation: | 1. 650‐225‐7547650‐225‐2797;2. Safety Assessment, Genentech, Inc., South San Francisco, California;3. Bioanalytical Sciences, Genentech, Inc., South San Francisco, California;4. Pharma Technical Regulatory, Genentech, Inc., South San Francisco, California;5. Analytical Operations, Genentech, Inc., South San Francisco, California;6. Protein Analytical Chemistry, Genentech, Inc., South San Francisco, California |
| Abstract: | |
| Keywords: | host cell protein bioprocess safety assessment immunogenicity process development |