Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers: Impact of Mechanism and Design on Drug Product Quality

Benson Gikanga; Yufei Chen; Oliver B. Stauch; Yuh-Fun Maa

doi:10.5731/pdajpst.2015.01031

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Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers: Impact of Mechanism and Design on Drug Product Quality

Benson Gikanga, Yufei Chen, Oliver B. Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology March 2015, 69 (2) 284-296; DOI: https://doi.org/10.5731/pdajpst.2015.01031

Benson Gikanga

Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080

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Yufei Chen

Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080

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Oliver B. Stauch

Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080

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Yuh-Fun Maa

Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080

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For correspondence: maay@gene.com

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vol. 69 no. 2 284-296

DOI

https://doi.org/10.5731/pdajpst.2015.01031

PubMed

25868994

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online April 13, 2015.

Author Information

Benson Gikanga,
Yufei Chen,
Oliver B. Stauch and
Yuh-Fun Maa*

Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, South San Francisco, CA 94080

↵*Corresponding Author: Yuh-Fun Maa, Genentech, a member of the Roche Group, 1 DNA Way South San Francisco, CA 94080. Telephone: 650-225-3499; Fax: 650-742-1504; e-mail: maay{at}gene.com

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Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers: Impact of Mechanism and Design on Drug Product Quality

Benson Gikanga, Yufei Chen, Oliver B. Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Mar 2015, 69 (2) 284-296; DOI: 10.5731/pdajpst.2015.01031

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Mixing Monoclonal Antibody Formulations Using Bottom-Mounted Mixers: Impact of Mechanism and Design on Drug Product Quality

Benson Gikanga, Yufei Chen, Oliver B. Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Mar 2015, 69 (2) 284-296; DOI: 10.5731/pdajpst.2015.01031

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Keywords

Bottom-mounted mixing
monoclonal antibody
Levitation mixer
Magnetic mixer
Disposables
Filter fouling
Particle formation

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