Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics—Drying Kinetics and Protein Aggregation

Andrea Allmendinger; Yuan Ni; Alexander Bernhard; Heiko Nalenz

doi:10.5731/pdajpst.2020.012492

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Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics—Drying Kinetics and Protein Aggregation

Andrea Allmendinger, Yuan Ni, Alexander Bernhard and Heiko Nalenz

PDA Journal of Pharmaceutical Science and Technology January 2022, 76 (1) 52-64; DOI: https://doi.org/10.5731/pdajpst.2020.012492

Andrea Allmendinger

aPharmaceutical Development & Supplies Biologics EU, F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland;

bDepartment of Pharmaceutical Technology and Biopharmacy, Institute of Pharmaceutical Sciences, Albert-Ludwigs-University Freiburg, Hermann-Herder-Str. 9, 79104 Freiburg, Germany

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For correspondence: allmendingerandrea@gmail.com

Yuan Ni

aPharmaceutical Development & Supplies Biologics EU, F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland;

bDepartment of Pharmaceutical Technology and Biopharmacy, Institute of Pharmaceutical Sciences, Albert-Ludwigs-University Freiburg, Hermann-Herder-Str. 9, 79104 Freiburg, Germany

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Alexander Bernhard

aPharmaceutical Development & Supplies Biologics EU, F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland;

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Heiko Nalenz

aPharmaceutical Development & Supplies Biologics EU, F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland;

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vol. 76 no. 1 52-64

DOI

https://doi.org/10.5731/pdajpst.2020.012492

PubMed

34282036

Published By

Parenteral Drug Association (PDA)

Print ISSN

1079-7440

Online ISSN

1948-2124

History

Published online February 1, 2022.

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previous version (July 19, 2021 - 10:39).
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Andrea Allmendinger^a,^b,*^,²,
Yuan Ni^a,^b,¹,
Alexander Bernhard^a and
Heiko Nalenz^a,

^aPharmaceutical Development & Supplies Biologics EU, F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland;
^bDepartment of Pharmaceutical Technology and Biopharmacy, Institute of Pharmaceutical Sciences, Albert-Ludwigs-University Freiburg, Hermann-Herder-Str. 9, 79104 Freiburg, Germany

↵*Corresponding Author: Pharmaceutical Development & Supplies Biologics EU, F. Hoffmann-La Roche, Grenzacherstrasse 124, 4070 Basel, Switzerland; Telephone: +41 61 68 77356; E-mail: allmendingerandrea{at}gmail.com

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Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics—Drying Kinetics and Protein Aggregation

Andrea Allmendinger, Yuan Ni, Alexander Bernhard, Heiko Nalenz

PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 52-64; DOI: 10.5731/pdajpst.2020.012492

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Mechanistic Study of Drying Phenomena of Highly Concentrated Protein Therapeutics—Drying Kinetics and Protein Aggregation

Andrea Allmendinger, Yuan Ni, Alexander Bernhard, Heiko Nalenz

PDA Journal of Pharmaceutical Science and Technology Jan 2022, 76 (1) 52-64; DOI: 10.5731/pdajpst.2020.012492

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Keywords

monoclonal antibody
highly concentrated protein formulation
Aseptic filling
drying events
nozzle clogging
fill-finish

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