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.

European Bioanalysis Forum recommendation on singlicate analysis for ligand binding assays: time for a new mindset

Bioanalysis ◽  
2020 ◽  
Vol 12 (5) ◽  
pp. 273-284 ◽  
Author(s):  
Matthew Barfield ◽  
Joanne Goodman ◽  
John Hood ◽  
Philip Timmerman
Keyword(s):  
Ligand Binding ◽  
Pharmacokinetic Analysis ◽  
Pharmacokinetic Parameters ◽  
Binding Assays ◽  
Bioanalytical Method Validation ◽  
Regulatory Guidelines ◽  
The Status ◽  
Analysis Strategy ◽  
Assay Methods ◽  
Pharmacokinetic Assay

It is well accepted that chromatographic assay methods employ singlicate analysis for toxicokinetic and pharmacokinetic analysis. While conversely, it has been the norm for ligand-binding assays to be run in at least duplicate analyses, stemming mainly from concerns over inherent assay variability and reagent quality. Regulatory guidelines and guidance on bioanalytical method validation has, in the most part, recommended multiple replicates for immunoassays and this has led to the industry being comfortable and familiar with duplicate analysis. Over the last few years, the discussion on whether singlicate analysis is acceptable for ligand-binding assays has grown and the status quo is being challenged for regulated bioanalysis performed using immunoassays. Through interrogation of preclinical and clinical pharmacokinetic assay data from the European Bioanalysis Forum community, the application of a singlicate analysis strategy has shown to have no impact on toxicokinetic and pharmacokinetic parameters when compared with duplicate analysis from the same studies. Therefore, now is the time to adopt a new mindset when it comes to sample analysis for toxicokinetic and pharmacokinetic ligand-binding assays and embrace singlicate analysis in the regulated environment.

Well-developed ligand-binding assays demonstrate robust performance using singlet analysis

Bioanalysis ◽  
2019 ◽  
Vol 11 (22) ◽  
pp. 2075-2086 ◽  
Author(s):  
Douglas Donaldson ◽  
Shobha Purushothama ◽  
Eric David ◽  
Kristopher King ◽  
Shuguang Huang ◽  
...  
Keyword(s):  
Ligand Binding ◽  
Test Tube ◽  
Comparable Data ◽  
Binding Assays ◽  
Robust Performance ◽  
Liquid Handling ◽  
Accuracy And Precision ◽  
Regulatory Guidelines ◽  
Sample Testing ◽  
Pharmacokinetic Assay

Aim: Replicate sample testing has long been regarded as a necessity for bioanalytical laboratory testing, especially in the realm of ligand-binding assays (LBAs). In an era in which results were derived from crude test tube-based assays, the replication of results was warranted. Those assays were often imprecise and required multiple replicates to arrive at results that approached accuracy. However, given technological advancements and excellent accuracy and precision of many modern LBAs, the practice of replicate testing should be re-evaluated. Although most regulatory guidelines allow for singlet testing when sufficient robustness and precision are demonstrated during validation, duplicate testing is still common practice. Recently however, several articles have been published that support singlet analysis for LBAs performed on a platform with automated liquid handling. Results: Data from five pharmacokinetic assay validations and five clinical and preclinical studies originally run in duplicate were re-evaluated in singlet and found to be nearly identical to the original duplicate results. Conclusion: We confirm that well-developed LBAs produce comparable data whether evaluated in singlet or duplicate. Additionally, automation is not requisite for singlet testing.

Serum sample stability in ligand-binding assays: challenges in assessments of long-term, bench-top and multiple freeze–thaw

Bioanalysis ◽  
2015 ◽  
Vol 7 (11) ◽  
pp. 1361-1370 ◽  
Author(s):  
Chris Macaraeg ◽  
Jessica Ortiz ◽  
Dominador Calamba ◽  
Mark Ma
Keyword(s):  
Ligand Binding ◽  
Serum Sample ◽  
Binding Assays ◽  
Freeze Thaw ◽  
Sample Stability

Critical reagent generation, characterization, handling and storage workflows: impact on ligand binding assays

Bioanalysis ◽  
2021 ◽  
Author(s):  
Elisa Oquendo ◽  
Jolaine Savoie ◽  
Joyce M Swenson ◽  
Christine Grimaldi
Keyword(s):  
Best Practices ◽  
Ligand Binding ◽  
Binding Assay ◽  
State Of The Art ◽  
Current Knowledge ◽  
Binding Assays ◽  
High Quality ◽  
The Past ◽  
Antidrug Antibodies ◽  
And Storage

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.

scholarly journals Critical reagents for ligand-binding assays: process development methodologies to enable high-quality reagents

Bioanalysis ◽  
2022 ◽  
Author(s):  
Caroline Kittinger ◽  
Jared Delmar ◽  
Lisa Hewitt ◽  
Rebecca Holcomb ◽  
Christopher Jones ◽  
...  
Keyword(s):  
Ligand Binding ◽  
Process Development ◽  
Process Conditions ◽  
Generation Process ◽  
Binding Assays ◽  
Performance Control ◽  
Development Approach ◽  
Immunogenicity Assays ◽  
The Impact

Development of biotherapeutics require pharmacokinetic/pharmacodynamic (PK/PD) and immunogenicity assays that are frequently in a ligand-binding assay (LBA) format. Conjugated critical reagents for LBAs are generated conjugation of the biotherapeutic drug or anti-drug molecule with a label. Since conjugated critical reagent quality impacts LBA performance, control of the generation process is essential. Our perspective is that process development methodologies should be integrated into critical reagent production to understand the impact of conjugation reactions, purification techniques and formulation conditions on the quality of the reagent. In this article, case studies highlight our approach to developing process conditions for different molecular classes of critical reagents including antibodies and a peptide. This development approach can be applied to the generation of future conjugated critical reagents.

Long-term Piloting Of Osmotic MBR For Potable Reuse: Performance, Life-Cycle Assessment, and Lessons Learned

2016 ◽  
Vol 2016 (14) ◽  
pp. 830-854
Author(s):  
Tzahi Y Cath ◽  
Ryan W Holloway ◽  
Leslie Miller-Robbie ◽  
Mehul Patel ◽  
Jennifer R Stokes ◽  
...  
Keyword(s):  
Life Cycle Assessment ◽  
Life Cycle ◽  
Lessons Learned ◽  
Potable Reuse

scholarly journals Liquid materials for biomedical research: a highly IT-integrated and automated biobanking solution

2019 ◽  
Vol 43 (6) ◽  
pp. 347-354 ◽  
Author(s):  
Daniela Popp ◽  
Romanus Diekmann ◽  
Lutz Binder ◽  
Abdul R. Asif ◽  
Sara Y. Nussbeck
Keyword(s):  
Life Cycle ◽  
Medical Center ◽  
Research Results ◽  
Long Term Storage ◽  
Medical Centers ◽  
It Systems ◽  
Complete Life Cycle ◽  
The University ◽  
Term Storage

Abstract Various information technology (IT) infrastructures for biobanking, networks of biobanks and biomaterial management are described in the literature. As pre-analytical variables play a major role in the downstream interpretation of clinical as well as research results, their documentation is essential. A description for mainly automated documentation of the complete life-cycle of each biospecimen is lacking so far. Here, the example taken is from the University Medical Center Göttingen (UMG), where the workflow of liquid biomaterials is standardized between the central laboratory and the central biobank. The workflow of liquid biomaterials from sample withdrawal to long-term storage in a biobank was analyzed. Essential data such as time and temperature for processing and freezing can be automatically collected. The proposed solution involves only one major interface between the main IT systems of the laboratory and the biobank. It is key to talk to all the involved stakeholders to ensure a functional and accepted solution. Although IT components differ widely between clinics, the proposed way of documenting the complete life-cycle of each biospecimen can be transferred to other university medical centers. The complete documentation of the life-cycle of each biospecimen ensures a good interpretability of downstream routine as well as research results.

scholarly journals The structure of SeviL, a GM1b/asialo-GM1 binding R-type lectin from the mussel Mytilisepta virgata

2020 ◽  
Vol 10 (1) ◽  
Author(s):  
Kenichi Kamata ◽  
Kenji Mizutani ◽  
Katsuya Takahashi ◽  
Roberta Marchetti ◽  
Alba Silipo ◽  
...  
Keyword(s):  
Immune System ◽  
Sialic Acid ◽  
Ligand Binding ◽  
Steric Hindrance ◽  
Sequence Similarity ◽  
Binding Assays ◽  
Subunit Interface ◽  
Nmr Techniques ◽  
And Control ◽  
Asialo Gm1

AbstractSeviL is a recently isolated lectin found to bind to the linear saccharides of the ganglioside GM1b (Neu5Ac$$\alpha$$ α (2-3)Gal$$\beta$$ β (1-3)GalNAc$$\beta$$ β (1-4)Gal$$\beta$$ β (1-4)Glc) and its precursor, asialo-GM1 (Gal$$\beta$$ β (1-3)GalNAc$$\beta$$ β (1-4)Gal$$\beta$$ β (1-4)Glc). The crystal structures of recombinant SeviL have been determined in the presence and absence of ligand. The protein belongs to the $$\beta$$ β -trefoil family, but shows only weak sequence similarity to known structures. SeviL forms a dimer in solution, with one binding site per subunit, close to the subunit interface. Molecular details of glycan recognition by SeviL in solution were analysed by ligand- and protein-based NMR techniques as well as ligand binding assays. SeviL shows no interaction with GM1 due to steric hindrance with the sialic acid branch that is absent from GM1b. This unusual specificity makes SeviL of great interest for the detection and control of certain cancer cells, and cells of the immune system, that display asialo-GM1.

scholarly journals Application of Plastic Wastes in Construction Materials: A Review Using the Concept of Life-Cycle Assessment in the Context of Recent Research for Future Perspectives

Materials ◽  
2021 ◽  
Vol 14 (13) ◽  
pp. 3549
Author(s):  
Tulane Rodrigues da Silva ◽  
Afonso Rangel Garcez de Azevedo ◽  
Daiane Cecchin ◽  
Markssuel Teixeira Marvila ◽  
Mugahed Amran ◽  
...  
Keyword(s):  
Life Cycle Assessment ◽  
Life Cycle ◽  
Solid Waste ◽  
Building Materials ◽  
Construction Materials ◽  
Plastic Waste ◽  
Plastic Wastes ◽  
Solid Waste Generation ◽  
Alternative Processes

The urbanization process contributes to the growth of solid waste generation and causes an increase in environmental impacts and failures in the management of solid waste. The number of dumps is a concern due to the limited implementation and safe disposal of this waste. The interest in sustainable techniques has been growing in relation to waste management, which is largely absorbed by the civil construction sector. This work aimed to review plastic waste, especially polyethylene terephthalate (PET), that can be incorporated with construction materials, such as concrete, mortars, asphalt mixtures, and paving. The use of life-cycle assessment (LCA) is related, as a tool that allows the sustainability of products and processes to be enhanced in the long term. After analyzing the recent literature, it was identified that studies related to plastic wastes in construction materials concentrate sustainability around the alternative destination of waste. Since the plastic waste from different production chains are obtained, it was possible to affirm the need for a broader assessment, such as the LCA, providing greater quantification of data making the alternative processes and products more sustainable. The study contributes to enhance sustainability in alternative building materials through LCA.

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