scholarly journals Development and validation of a platform reduced intact mass method for process monitoring of monoclonal antibody glycosylation during routine manufacturing

Bioengineered ◽  
2020 ◽  
Vol 11 (1) ◽  
pp. 1301-1312 ◽  
Author(s):  
Michael Schilling ◽  
Pamela Feng ◽  
Zoran Sosic ◽  
Stacey L. Traviglia
Keyword(s):  
Monoclonal Antibody ◽  
Process Monitoring ◽  
Intact Mass ◽  
Development And Validation

scholarly journals Challenges, pitfalls and surprises: development and validation of a monoclonal antibody for enzyme immunoassay of the steroid 1α-hydroxycorticosterone in elasmobranch species

2018 ◽  
Vol 265 ◽  
pp. 83-89 ◽  
Author(s):  
Catharine J. Wheaton ◽  
Natalie D. Mylniczenko ◽  
John M. Rimoldi ◽  
Rama S.V.S. Gadepalli ◽  
R. Hart ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Enzyme Immunoassay ◽  
Elasmobranch Species ◽  
Development And Validation

Abstract 4595: Development and validation of a novel EGF receptor-neutralizing monoclonal antibody

2016 ◽  
Author(s):  
Krystyna Zuberek Hincman ◽  
Christopher A. Manning ◽  
Michael R. Nelson ◽  
Michael Lewis ◽  
Roy Scialdone ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Egf Receptor ◽  
Neutralizing Monoclonal Antibody ◽  
Development And Validation

Development and validation of H11B2C2 monoclonal antibody-reactive hyaluronic acid binding protein: overexpression of HABP during human tumor progression

Tumor Biology ◽  
2012 ◽  
Vol 34 (1) ◽  
pp. 597-608 ◽  
Author(s):  
Rajeev K Boregowda ◽  
Hitesh N. Appaiah ◽  
Mortha Karunakumar ◽  
Shivanna Parameshwariah ◽  
Geetha Avadani ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Hyaluronic Acid ◽  
Tumor Progression ◽  
Binding Protein ◽  
Human Tumor ◽  
Protein Overexpression ◽  
Acid Binding Protein ◽  
Development And Validation ◽  
Hyaluronic Acid Binding

scholarly journals Development and validation of a direct competitive monoclonal antibody-based immunoassay for the sensitive and selective analysis of the phytoregulator forchlorfenuron

2012 ◽  
Vol 403 (7) ◽  
pp. 2019-2026 ◽  
Author(s):  
Celia Suárez-Pantaleón ◽  
Francesc A. Esteve-Turrillas ◽  
Josep V. Mercader ◽  
Consuelo Agulló ◽  
Antonio Abad-Somovilla ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Development And Validation ◽  
Selective Analysis

Development and Validation of Monoclonal Antibody-Based Antigen Capture ELISA for Detection of Group A Porcine Rotavirus

2017 ◽  
Vol 30 (4) ◽  
pp. 264-270 ◽  
Author(s):  
Atta Muhammad Memon ◽  
Anjuman Ara Bhuyan ◽  
Fangzhou Chen ◽  
Xiaozhen Guo ◽  
Harish Menghwar ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Capture Elisa ◽  
Antigen Capture Elisa ◽  
Antigen Capture ◽  
Group A ◽  
Development And Validation ◽  
Porcine Rotavirus

scholarly journals Development and validation of a method for the determination of the specific activity of recombinant monoclonal antibody eculizumab

2020 ◽  
Vol 15 (2) ◽  
pp. 77-85
Author(s):  
D. I. Zybin ◽  
A. S. Seregin ◽  
A. D. Askretkov ◽  
N. V. Orlova ◽  
Yu. A. Seregin ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Pharmaceutical Analysis ◽  
Comparative Evaluation ◽  
Specific Activity ◽  
In Vitro Method ◽  
Recombinant Monoclonal Antibody ◽  
Development And Validation ◽  
First Time

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. 

Development and Validation of a Monoclonal Antibody-Based Enzyme-Linked Immunosorbent Assay for Salinomycin in Chicken Liver Tissue

1995 ◽  
Vol 43 (6) ◽  
pp. 1745-1750 ◽  
Author(s):  
Mark T. Muldoon ◽  
Marcel H. Elissalde ◽  
Ross C. Beier ◽  
Larry H. Stanker
Keyword(s):  
Monoclonal Antibody ◽  
Immunosorbent Assay ◽  
Liver Tissue ◽  
Chicken Liver ◽  
Enzyme Linked Immunosorbent Assay ◽  
Development And Validation

Development and Validation of a Monoclonal Antibody-Based Indirect Competitive ELISA for the Detection of Sudan I in Duck Eggs and Crystal Violet in Carp

2016 ◽  
Vol 10 (5) ◽  
pp. 1442-1451 ◽  
Author(s):  
Dapeng Peng ◽  
Liyan Zhang ◽  
Changyou Zhai ◽  
Yulian Wang ◽  
Dongmei Chen ◽  
...  
Keyword(s):  
Monoclonal Antibody ◽  
Crystal Violet ◽  
Competitive Elisa ◽  
Indirect Competitive Elisa ◽  
Sudan I ◽  
Development And Validation
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