The Use of Flow Cytometry for the Detection of Subvisible Particles in Therapeutic Protein Formulations

2011 ◽  
Vol 100 (5) ◽  
pp. 1671-1678 ◽  
Author(s):  
Henryk Mach ◽  
Akhilesh Bhambhani ◽  
Brian K. Meyer ◽  
Steven Burek ◽  
Harrison Davis ◽  
...  
Keyword(s):  
Flow Cytometry ◽  
Therapeutic Protein ◽  
Subvisible Particles ◽  
Protein Formulations

Entrepreneurship and Regional Development: State of the Art

2019 ◽  
Vol 5 (2) ◽  
pp. 58-66
Author(s):  
Luísa Carvalho
Keyword(s):  
Regional Development ◽  
State Of The Art ◽  
Therapeutic Protein ◽  
Subvisible Particles ◽  
Protein Formulations ◽  
Parenteral Formulations ◽  
Development State ◽  
Formulation Stability

The presence of subvisible particles (SVPs) in parenteral formulations of biologics is a major challenge in the development of therapeutic protein formulations. Distinction between proteinaceous and non-proteinaceous SVPs is vital in monitoring formulation stability.

scholarly journals Overlooking Subvisible Particles in Therapeutic Protein Products: Gaps That May Compromise Product Quality

2009 ◽  
Vol 98 (4) ◽  
pp. 1201-1205 ◽  
Author(s):  
John F. Carpenter ◽  
Theodore W. Randolph ◽  
Wim Jiskoot ◽  
Daan J.A. Crommelin ◽  
C. Russell Middaugh ◽  
...  
Keyword(s):  
Product Quality ◽  
Therapeutic Protein ◽  
Subvisible Particles

scholarly journals Flow cytometry: A promising technique for the study of silicone oil-induced particulate formation in protein formulations

2011 ◽  
Vol 410 (2) ◽  
pp. 191-199 ◽  
Author(s):  
D. Brett Ludwig ◽  
Joseph T. Trotter ◽  
John P. Gabrielson ◽  
John F. Carpenter ◽  
Theodore W. Randolph
Keyword(s):  
Flow Cytometry ◽  
Silicone Oil ◽  
Promising Technique ◽  
Protein Formulations

Key interactions of surfactants in therapeutic protein formulations: A review

2015 ◽  
Vol 97 ◽  
pp. 60-67 ◽  
Author(s):  
Tarik A. Khan ◽  
Hanns-Christian Mahler ◽  
Ravuri S.K. Kishore
Keyword(s):  
Therapeutic Protein ◽  
Protein Formulations

Particles in Therapeutic Protein Formulations, Part 1: Overview of Analytical Methods

2012 ◽  
Vol 101 (3) ◽  
pp. 914-935 ◽  
Author(s):  
Sarah Zölls ◽  
Ruedeeporn Tantipolphan ◽  
Michael Wiggenhorn ◽  
Gerhard Winter ◽  
Wim Jiskoot ◽  
...  
Keyword(s):  
Analytical Methods ◽  
Therapeutic Protein ◽  
Protein Formulations
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