Precipitation with polyelectrolytes is a promising alternative to conventional methods for purification of monoclonal antibodies (mAb). This study focuses on clarification of a monoclonal antibody by precipitation of the model impurity bovine serum albumin (BSA) with cationic polyelectrolytes. Different types of cationic polyelectrolytes with different functional amine groups and molecular weights are screened for their capability to precipitate BSA in mixture with mAb. Due to the high BSA depletion and mAb recovery achieved, two cationic polyelectrolytes, polyethyleneimine (PEI) and polyallylamine (PAA) with a molecular weight of 65 kDa were selected as most suitable precipitation agents. Additionally, influences of different parameters (polyelectrolyte, BSA and NaCI concentration and pH value) were analyzed by the use of design of experiments (DoE). Herewith, a fast identification of influencing factors and factor interaction was achieved. With DoE, two regression models for the analysis of BSA depletion in dependence of influencing factors were established. This enabled the analysis of the robustness of precipitation as initial clarification step of downstream process of mAb. (C) 2017 Elsevier B.V. All rights reserved.
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Genentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USAGenentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USA
McDonald, Paul
Victa, Corazon
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Genentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USAGenentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USA
Victa, Corazon
Carter-Franklin, Jayme N.
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Genentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USAGenentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USA
Carter-Franklin, Jayme N.
Fahrner, Robert
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Genentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USAGenentech Inc, Proc Res & Dev, Early Stage Purificat, San Francisco, CA 94080 USA
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Genentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USAGenentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USA
Peram, Thanmaya
McDonald, Paul
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Genentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USAGenentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USA
McDonald, Paul
Carter-Franklin, Jayme
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Genentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USAGenentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USA
Carter-Franklin, Jayme
Fahrner, Robert
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Genentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USAGenentech Inc, Early Stage Purificat Proc Res & Dev, San Francisco, CA 94080 USA
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Fed Univ Rio De Janeiro UFRJ, COPPE, Chem Engn Program, Cell Culture Engn Lab LECC, BR-21941598 Rio De Janeiro, BrazilFed Univ Rio De Janeiro UFRJ, COPPE, Chem Engn Program, Cell Culture Engn Lab LECC, BR-21941598 Rio De Janeiro, Brazil
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Bristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USABristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USA
Singh, Nripen
Arunkumar, Abhiram
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Bristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USABristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USA
Arunkumar, Abhiram
Chollangi, Srinivas
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Bristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USABristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USA
Chollangi, Srinivas
Tan, Zhijun George
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Bristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USABristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USA
Tan, Zhijun George
Borys, Michael
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Bristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USABristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USA
Borys, Michael
Li, Zheng Jian
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Bristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USABristol Myers Squibb Co, Global Mfg & Supply, Biol Dev, 35 South St, Hopkinton, MA 01748 USA