Chapter 24: Considerations and Challenges When Filling High-Concentration Monoclonal Antibody Formulations into Prefilled Syringes

2020 ◽  
pp. 591-612
Author(s):  
Wendy Shieu ◽  
Yuh-Fun Maa
Keyword(s):  
Monoclonal Antibody ◽  
High Concentration ◽  
Prefilled Syringes

scholarly journals High concentration tangential flow ultrafiltration of stable monoclonal antibody solutions with low viscosities

2016 ◽  
Vol 508 ◽  
pp. 113-126 ◽  
Author(s):  
Jessica J. Hung ◽  
Ameya U. Borwankar ◽  
Barton J. Dear ◽  
Thomas M. Truskett ◽  
Keith P. Johnston
Keyword(s):  
Monoclonal Antibody ◽  
High Concentration ◽  
Tangential Flow

Lyophilization Cycle Development for a High-Concentration Monoclonal Antibody Formulation Lacking a Crystalline Bulking Agent

2007 ◽  
Vol 96 (6) ◽  
pp. 1598-1608 ◽  
Author(s):  
James D. Colandene ◽  
Linda M. Maldonado ◽  
Alma T. Creagh ◽  
John S. Vrettos ◽  
Kenneth G. Goad ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Bulking Agent ◽  
High Concentration

A Formulation Development Approach to Identify and Select Stable Ultra–High-Concentration Monoclonal Antibody Formulations With Reduced Viscosities

2017 ◽  
Vol 106 (11) ◽  
pp. 3230-3241 ◽  
Author(s):  
Neal Whitaker ◽  
Jian Xiong ◽  
Samantha E. Pace ◽  
Vineet Kumar ◽  
C. Russell Middaugh ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Formulation Development ◽  
High Concentration ◽  
Development Approach

Characterization of the photodegradation of a human IgG1 monoclonal antibody formulated as a high-concentration liquid dosage form

2009 ◽  
Vol 98 (9) ◽  
pp. 3117-3130 ◽  
Author(s):  
Pei Qi ◽  
David B. Volkin ◽  
Hui Zhao ◽  
Michael L. Nedved ◽  
Robert Hughes ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Dosage Form ◽  
High Concentration ◽  
Igg1 Monoclonal Antibody ◽  
Human Igg1 ◽  
Liquid Dosage Form ◽  
Human Igg1 Monoclonal Antibody

Characterizing protein–protein-interaction in high-concentration monoclonal antibody systems with the quartz crystal microbalance

2017 ◽  
Vol 19 (48) ◽  
pp. 32698-32707 ◽  
Author(s):  
Josef Hartl ◽  
Astrid Peschel ◽  
Diethelm Johannsmann ◽  
Patrick Garidel
Keyword(s):  
Monoclonal Antibody ◽  
Quartz Crystal Microbalance ◽  
Protein Interaction ◽  
Quartz Crystal ◽  
Therapeutic Antibodies ◽  
High Concentration ◽  
Concentrated Solutions ◽  
Protein Protein Interaction

Making use of a quartz crystal microbalance, concentrated solutions of therapeutic antibodies were studied with respect to their behavior under shear excitation with frequencies in the MHz range.

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

2015 ◽  
Vol 69 (1) ◽  
pp. 59-73 ◽  
Author(s):  
B. Gikanga ◽  
R. Turok ◽  
A. Hui ◽  
M. Bowen ◽  
O. B. Stauch ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Spray Drying ◽  
High Concentration ◽  
The Road

scholarly journals Stability of a high-concentration monoclonal antibody solution produced by liquid–liquid phase separation

mAbs ◽  
2021 ◽  
Vol 13 (1) ◽  
pp. 1940666
Author(s):  
Jack E. Bramham ◽  
Stephanie A. Davies ◽  
Adrian Podmore ◽  
Alexander P. Golovanov
Keyword(s):  
Monoclonal Antibody ◽  
Phase Separation ◽  
Liquid Phase ◽  
Liquid Phase Separation ◽  
High Concentration ◽  
Antibody Solution ◽  
Liquid Liquid Phase Separation
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