Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations

Benson Gikanga; Ada Hui; Yuh-Fun Maa

doi:10.5731/pdajpst.2017.007732

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Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations

Benson Gikanga, Ada Hui and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology March 2018, 72 (2) 117-133; DOI: https://doi.org/10.5731/pdajpst.2017.007732

Benson Gikanga

1Pharmaceutical Processing and Technology Development, Genentech, South San Francisco, CA; and

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Ada Hui

2Late Stage Pharmaceutical Development, Genentech, South San Francisco, CA

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Yuh-Fun Maa

1Pharmaceutical Processing and Technology Development, Genentech, South San Francisco, CA; and

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For correspondence: maay@gene.com

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vol. 72 no. 2 117-133

DOI

https://doi.org/10.5731/pdajpst.2017.007732

PubMed

29030532

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

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Published online March 23, 2018.

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previous version (October 12, 2017 - 19:14).
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Benson Gikanga1,
Ada Hui2 and
Yuh-Fun Maa1,*

¹Pharmaceutical Processing and Technology Development, Genentech, South San Francisco, CA; and
²Late Stage Pharmaceutical Development, Genentech, South San Francisco, CA

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

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Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations

Benson Gikanga, Ada Hui, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 117-133; DOI: 10.5731/pdajpst.2017.007732

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Mechanistic Investigation on Grinding-Induced Subvisible Particle Formation during Mixing and Filling of Monoclonal Antibody Formulations

Benson Gikanga, Ada Hui, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Mar 2018, 72 (2) 117-133; DOI: 10.5731/pdajpst.2017.007732

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Keywords

Grinding stress
monoclonal antibody
Subvisible particles
HMWs
LMWs
Cavitation
Sonication
Thermal stress
Spray drying

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