Current and effective strategies for critical reagent characterization, storage, stability, retesting and life cycle management for ligand-binding assays and flow cytometry

Bioanalysis ◽  
2021 ◽  
Vol 13 (10) ◽  
pp. 737-740
Author(s):  
Lakshmi Amaravadi ◽  
Nisha Palackal ◽  
Fabio Garofolo
Keyword(s):  
Flow Cytometry ◽  
Life Cycle ◽  
Ligand Binding ◽  
Storage Stability ◽  
Life Cycle Management ◽  
Binding Assays ◽  
Effective Strategies ◽  
Reagent Characterization

scholarly journals EBF recommendation on practical management of critical reagents for antidrug antibody ligand-binding assays

Bioanalysis ◽  
2019 ◽  
Vol 11 (19) ◽  
pp. 1787-1798 ◽  
Author(s):  
Susanne Pihl ◽  
Barry WA van der Strate ◽  
Michaela Golob ◽  
Janka Ryding ◽  
Laurent Vermet ◽  
...  
Keyword(s):  
Life Cycle ◽  
Ligand Binding ◽  
Crucial Role ◽  
Binding Assays ◽  
Antidrug Antibody ◽  
Regulatory Guidelines ◽  
Minimum Requirements ◽  
Antidrug Antibodies ◽  
Immunogenicity Assays

Immunogenicity (ISI) assays are required to measure antidrug antibodies that are generated against biotherapeutic modalities. As for any ligand-binding assays, critical reagents (CR) play a crucial role in immunogenicity assays, as the robustness and reliability of an assay are defined by the quality and long-term availability of these reagents. The current regulatory guidelines do not provide clear directions on how to implement and verify lot-to-lot changes of CR during an assay life cycle, or the acceptance criteria that should be used when implementing new lots of CR. These aspects were extensively discussed within the European Bioanalysis Forum community. In this paper, CR for immunogenicity assays are identified and the minimum requirements for introducing new lots of CR in immunogenicity assays are described.

Critical reagents in flow cytometry, instrumentation and application in drug discovery development

Bioanalysis ◽  
2021 ◽  
Author(s):  
Vellalore N Kakkanaiah ◽  
Katie Matys ◽  
Patrick Bennett
Keyword(s):  
Flow Cytometry ◽  
Drug Discovery ◽  
Drug Development ◽  
Ligand Binding ◽  
Specific Interaction ◽  
Flow Cytometer ◽  
Analysis Tool ◽  
Binding Assays ◽  
Cellular Analysis ◽  
Main Components

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.

Best Practices on Critical Reagent Characterization, Qualification, and Life Cycle Management for HCP Immunoassays

2021 ◽  
Author(s):  
Tobias Graf ◽  
Christina Seisenberger ◽  
Michael Wiedmann ◽  
Stefanie Wohlrab ◽  
Oliver Anderka
Keyword(s):  
Life Cycle ◽  
Best Practices ◽  
Life Cycle Management ◽  
Reagent Characterization

Life cycle management of critical ligand-binding reagents

Bioanalysis ◽  
2013 ◽  
Vol 5 (21) ◽  
pp. 2679-2696 ◽  
Author(s):  
Denise M O'Hara ◽  
Valerie Theobald
Keyword(s):  
Life Cycle ◽  
Ligand Binding ◽  
Life Cycle Management

Effectiveness Of Life Cycle Management Of Projects Using Information Modeling

2019 ◽  
pp. 24-29 ◽  
Keyword(s):  
Life Cycle ◽  
Construction Projects ◽  
Life Cycle Management ◽  
Information Modeling ◽  
Engineering Systems ◽  
Basic Principles ◽  
Complex Engineering ◽  
Domestic Practices ◽  
Capital Construction ◽  
Complex Engineering Systems

Improving the efficiency of life cycle management of capital construction projects using information modeling technologies is one of the important tasks of the construction industry. The paper presents an analysis of accumulated domestic practices, including the legal and regulatory framework, assessing the effectiveness of managing the implementation of investment construction projects and of complex and serial capital construction projects, as well as the life cycle management of especially dangerous technically complex and unique capital construction projects using information modeling technologies, especially capital construction projects, as well as their supporting and using systems, primarily in the nuclear and transport sectors. A review of modern approaches to assessing the effectiveness of life cycle management systems of complex engineering systems in relation to capital construction projects is carried out. The presented material will make it possible to formulate the basic principles and prospects of applying approaches to assessing the effectiveness of the life cycle management system of a capital construction project using information modeling technologies.

Life Cycle of Construction Objects at Information Simulation of Buildings and Structures

2019 ◽  
pp. 65-72 ◽  
Keyword(s):  
Life Cycle ◽  
Construction Projects ◽  
Life Cycle Management ◽  
Information Modeling ◽  
Sources Of Information ◽  
Logical Scheme ◽  
Modeling Technology ◽  
Information Models ◽  
Building Information ◽  
The Russian Federation

The variants of the division of the life cycle of a construction object at the stages adopted in the territory of the Russian Federation, as well as in other countries are considered. Particular attention is paid to the exemplary work plan – "RIBA plan of work", used in England. A feature of this document is its applicability in the information modeling of construction projects (Building information Modeling – BIM). The article presents a structural and logical scheme of the life cycle of a building object and a list of works that are performed using information modeling technology at various stages of the life cycle of the building. The place of information models in the process of determining the service life of the building is shown. On the basis of the considered sources of information, promising directions for the development of the life cycle management system of the construction object (Life Cycle Management) and the development of the regulatory framework in order to improve the use of information modeling in construction are given.

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