Development and validation of a UPLC-MS/MS method to quantitate anti-PD1 monoclonal antibody (Toripalimab), and comparison with electrochemiluminescence immunoassay

Author(s):  
Shuxia Liu ◽  
Jianliang Yang ◽  
Sheng Yang ◽  
Qiaoyun Tan ◽  
Liyuan Dai ◽  
...  
2016 ◽  
Author(s):  
Krystyna Zuberek Hincman ◽  
Christopher A. Manning ◽  
Michael R. Nelson ◽  
Michael Lewis ◽  
Roy Scialdone ◽  
...  

Tumor Biology ◽  
2012 ◽  
Vol 34 (1) ◽  
pp. 597-608 ◽  
Author(s):  
Rajeev K Boregowda ◽  
Hitesh N. Appaiah ◽  
Mortha Karunakumar ◽  
Shivanna Parameshwariah ◽  
Geetha Avadani ◽  
...  

2012 ◽  
Vol 403 (7) ◽  
pp. 2019-2026 ◽  
Author(s):  
Celia Suárez-Pantaleón ◽  
Francesc A. Esteve-Turrillas ◽  
Josep V. Mercader ◽  
Consuelo Agulló ◽  
Antonio Abad-Somovilla ◽  
...  

2017 ◽  
Vol 30 (4) ◽  
pp. 264-270 ◽  
Author(s):  
Atta Muhammad Memon ◽  
Anjuman Ara Bhuyan ◽  
Fangzhou Chen ◽  
Xiaozhen Guo ◽  
Harish Menghwar ◽  
...  

Author(s):  
D. I. Zybin ◽  
A. S. Seregin ◽  
A. D. Askretkov ◽  
N. V. Orlova ◽  
Yu. A. Seregin ◽  
...  

Objectives. Developing reliable and accurate analytical methods is necessary for comparative pharmaceutical analysis using physicochemical, biological (in vitro), preclinical, and clinical trials. The main objective of this study was to develop and validate an in vitro method for determining the specific activity of the recombinant monoclonal antibody eculizumab.Methods. The method of indirect enzyme immunoassay was used in the study.Results. A method for determining the specific activity of the humanized recombinant monoclonal antibody eculizumab was described and validated for the first time. A comparative evaluation of the specific activity of Soliris® (Alexion Pharmaceuticals Inc., USA), and its biosimilar PRK-001 (Pharmapark, Russia) was performed using the developed method.Conclusions. The similarity of PRK-001 and the original Soliris® in relation to their specific activity, that is, binding to the human complement system C5 protein, was proved. 


Tumor Biology ◽  
2012 ◽  
Vol 34 (1) ◽  
pp. 609-609
Author(s):  
Rajeev K. Boregowda ◽  
Hitesh N. Appaiah ◽  
Mortha Karunakumar ◽  
Shivanna Parameshwariah ◽  
Geetha Avadani ◽  
...  

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