Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging

Wendy Shieu; Oliver B. Stauch; Yuh-Fun Maa

doi:10.5731/pdajpst.2015.01055

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Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging

Wendy Shieu, Oliver B. Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 417-426; DOI: https://doi.org/10.5731/pdajpst.2015.01055

Wendy Shieu

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

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Oliver B. Stauch

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

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Yuh-Fun Maa

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

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For correspondence: maay@gene.com

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vol. 69 no. 3 417-426

DOI

https://doi.org/10.5731/pdajpst.2015.01055

PubMed

26048747

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online June 4, 2015.

Author Information

Wendy Shieu,
Oliver B. Stauch and
Yuh-Fun Maa*

Pharmaceutical Processing and Technology Development, Genentech, a member of the Roche Group, 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: 650-225-3499; Fax: 650-742-1504; e-mail: maay{at}gene.com

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Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging

Wendy Shieu, Oliver B. Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 417-426; DOI: 10.5731/pdajpst.2015.01055

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Filling of High-Concentration Monoclonal Antibody Formulations into Pre-filled Syringes: Investigating Formulation-Nozzle Interactions To Minimize Nozzle Clogging

Wendy Shieu, Oliver B. Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology May 2015, 69 (3) 417-426; DOI: 10.5731/pdajpst.2015.01055

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Keywords

prefilled syringe
High-concentration monoclonal antibody
Suck-back
Hydrophilic nozzles
Hydrophobic nozzles
nozzle clogging

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