Laboratory automation of high-quality and efficient ligand-binding assays for biotherapeutic drug development

Bioanalysis ◽  
2013 ◽  
Vol 5 (13) ◽  
pp. 1635-1648 ◽  
Author(s):  
Jin Wang ◽  
Vimal Patel ◽  
Daniel Burns ◽  
John Laycock ◽  
Kinnari Pandya ◽  
...  
Bioanalysis ◽  
2021 ◽  
Author(s):  
Vellalore N Kakkanaiah ◽  
Katie Matys ◽  
Patrick Bennett

Flow cytometer is a powerful cellular analysis tool consists of three main components; fluidics, optics and electronics. Flow cytometry methods have been used in all stages of drug development as like ligand binding assays (LBA). Both LBA and flow cytometry methods require specific interaction between the critical reagents and the analytes. Antibodies and their conjugates, viable dyes and permeabilizing buffer are the main critical reagents in flow cytometry methods. Similarly, antibodies, engineered proteins and their conjugates are the main critical reagents in LBA. The main difference between the two methods is the lack of true reference standards for flow cytometry cellular analysis.


2012 ◽  
Vol 14 (1) ◽  
pp. 142-153 ◽  
Author(s):  
Ago B. Ahene ◽  
Chris Morrow ◽  
David Rusnak ◽  
Susan Spitz ◽  
Joel Usansky ◽  
...  

2013 ◽  
pp. 647-657
Author(s):  
Jeffrey M. Sailstad ◽  
Ronald R. Bowsher ◽  
Omar F. Laterza ◽  
William Nowatzke

2015 ◽  
Vol 18 (1) ◽  
pp. 1-14 ◽  
Author(s):  
Darshana Jani ◽  
John Allinson ◽  
Flora Berisha ◽  
Kyra J. Cowan ◽  
Viswanath Devanarayan ◽  
...  

Bioanalysis ◽  
2021 ◽  
Author(s):  
Elisa Oquendo ◽  
Jolaine Savoie ◽  
Joyce M Swenson ◽  
Christine Grimaldi

The foundation of pharmacokinetics and antidrug antibodies assay robustness relies on the use of high-quality reagents. Over the past decade, there has been increasing interest within the pharmaceutical industry, as well as regulators, on defining best practices and scientific approaches for generation, characterization and handling of critical reagents. In this review, we will discuss current knowledge and practices on critical reagent workflows and state-of-the-art approaches for characterization, generation, stability and storage and how each of these steps can impact ligand-binding assay robustness.


2009 ◽  
pp. 39-79 ◽  
Author(s):  
Masood N. Khan ◽  
Proveen D. Dass ◽  
John H. Leete ◽  
Richard F. Schuman ◽  
Michele Gunsior ◽  
...  

2020 ◽  
pp. 16-37
Author(s):  
Stanislav Cherepushkin

The use and development of biotherapeutics increases and the need for accurate, sensitive and robust bioanalytical methods is also increasing. ELISA and other ligand-binding assays are the most widely used methods for the quantification of macromolecules in complex biological samples. One of the alternatives to ELISA is AlphaLISA — a versatile chemiluminescent ligand binding assay using a homogeneous no-wash protocol. AlphaLISA assays are suited for automation and exhibit high sensitivity, high throughput and wide analytical range. Since the early 2000s, this method has been used in science, medicine, and drug development for wide variety of applications, including the quantification of analytes, immunogenicity, protein-protein interactions, enzyme activity, post-translational modifications and epigenetics. In this review, we describe the principles of the AlphaLISA assay and its application in bioanalytical studies (pharmacokinetics and immunogenicity) and high-throughput screening in drug development, medical diagnostics and pathogens detection.


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