Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress

Benson Gikanga; Devon Roshan-Eisner; Robert Ovadia; Eric S. Day; Oliver Boris Stauch; Yuh-Fun Maa

doi:10.5731/pdajpst.2016.006726

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Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress

Benson Gikanga, Devon Roshan-Eisner, Robert Ovadia, Eric S. Day, Oliver Boris Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology October 2016, pdajpst.2016.006726; DOI: https://doi.org/10.5731/pdajpst.2016.006726

Benson Gikanga

1 Genentech;

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For correspondence: gikanga.benson@gene.com

Devon Roshan-Eisner

1 Genentech;

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For correspondence: roshan-eisner.devon@gene.com

Robert Ovadia

1 Genentech;

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For correspondence: ovadia.robert@gene.com

Eric S. Day

1 Genentech;

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For correspondence: daye3@gene.com

Oliver Boris Stauch

2 Genentech Inc.

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For correspondence: staucho@gene.com

Yuh-Fun Maa

1 Genentech;

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For correspondence: maay@gene.com

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Article Information

pdajpst.2016.006726

DOI

https://doi.org/10.5731/pdajpst.2016.006726

PubMed

27789805

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Received June 28, 2016
Accepted October 12, 2016
Published online October 27, 2016.

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Author Information

Benson Gikanga1 (gikanga.benson{at}gene.com),
Devon Roshan-Eisner1 (roshan-eisner.devon{at}gene.com),
Robert Ovadia1 (ovadia.robert{at}gene.com),
Eric S. Day1 (daye3{at}gene.com),
Oliver Boris Stauch2 (staucho{at}gene.com) and
Yuh-Fun Maa1,3 (maay{at}gene.com)

¹ Genentech;
² Genentech Inc.

↵* Corresponding author; email: maay{at}gene.com

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Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress

Benson Gikanga, Devon Roshan-Eisner, Robert Ovadia, Eric S. Day, Oliver Boris Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Oct 2016, pdajpst.2016.006726; DOI: 10.5731/pdajpst.2016.006726

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Processing Impact on Monoclonal Antibody Drug Products: Protein Subvisible Particulate Formation Induced by Grinding Stress

Benson Gikanga, Devon Roshan-Eisner, Robert Ovadia, Eric S. Day, Oliver Boris Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Oct 2016, pdajpst.2016.006726; DOI: 10.5731/pdajpst.2016.006726

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Keywords

Bottom-mounted mixers
JetMixer
LevMixer®
Mobius® mixer
monoclonal antibody
Subvisible particles

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