Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale

Benson Gikanga; Robert Turok; Ada Hui; Mayumi Bowen; Oliver B. Stauch; Yuh-Fun Maa

doi:10.5731/pdajpst.2015.01003

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Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale

Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch and Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology January 2015, 69 (1) 59-73; DOI: https://doi.org/10.5731/pdajpst.2015.01003

Benson Gikanga

aPharmaceutical Processing and Technology Development;

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Robert Turok

cSPX Flow Technology Systems, Inc., Elkridge, MD

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Ada Hui

bLate-Stage Pharmaceutical Development, Genentech, Inc., a member of the Roche Group, South San Francisco, CA; and

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Mayumi Bowen

aPharmaceutical Processing and Technology Development;

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Oliver B. Stauch

aPharmaceutical Processing and Technology Development;

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Yuh-Fun Maa

aPharmaceutical Processing and Technology Development;

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For correspondence: maay@gene.com

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Article Information

vol. 69 no. 1 59-73

DOI

https://doi.org/10.5731/pdajpst.2015.01003

PubMed

25691715

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online February 17, 2015.

Author Information

Benson Gikangaa,
Robert Turokc,
Ada Huib,
Mayumi Bowena,
Oliver B. Staucha and
Yuh-Fun Maaa,*

^aPharmaceutical Processing and Technology Development;
^bLate-Stage Pharmaceutical Development, Genentech, Inc., a member of the Roche Group, South San Francisco, CA; and
^cSPX Flow Technology Systems, Inc., Elkridge, MD

↵*Corresponding Author: Yuh-Fun Maa, Telephone: 650-225-3499; Fax: 650-742-1504; e-mail: maay{at}gene.com

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Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale

Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 59-73; DOI: 10.5731/pdajpst.2015.01003

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Manufacturing of High-Concentration Monoclonal Antibody Formulations via Spray Drying—the Road to Manufacturing Scale

Benson Gikanga, Robert Turok, Ada Hui, Mayumi Bowen, Oliver B. Stauch, Yuh-Fun Maa

PDA Journal of Pharmaceutical Science and Technology Jan 2015, 69 (1) 59-73; DOI: 10.5731/pdajpst.2015.01003

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Spray drying
Monoclonal antibody (mAb)
Powder collection yield
Powder reconstitution
Water content
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