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 ◽  
...  
2019 ◽  
Vol 5 (2) ◽  
pp. 58-66
Author(s):  
Luísa Carvalho

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.


Author(s):  
Tarik A. Khan ◽  
Hanns-Christian Mahler ◽  
Ravuri S.K. Kishore

2011 ◽  
Vol 100 (5) ◽  
pp. 1671-1678 ◽  
Author(s):  
Henryk Mach ◽  
Akhilesh Bhambhani ◽  
Brian K. Meyer ◽  
Steven Burek ◽  
Harrison Davis ◽  
...  

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