Anti-drug Antibody Sample Testing and Reporting Harmonization

Jani, Darshana; Marsden, Robin; Gunsior, Michele; Hay, Laura; Ward, Bethany; Cowan, Kyra J.; Azadeh, Mitra; Barker, Breann; Cao, Liching; Closson, Kristin R.; Coble, Kelly; Dholakiya, Sanjay L.; Dusseault, Julie; Hays, Amanda; Herl, Carina; Hodsdon, Michael E.; Irvin, Susan C.; Kirshner, Susan; Kolaitis, Gerry; Kulagina, N. V.; Kumar, Seema; Lai, Ching Ha; Lipari, Francesco; Liu, Susana; Merdek, Keith D.; Moldovan, Ioana; Mozaffari, Reza; Pan, Luying; Place, Corina; Snoeck, Veerle; Manning, Marta Starcevic; Stocker, Dennis; Tary‐Lehmann, Magdalena; Turner, Amy S.; Vainshtein, Inna; Verthelyi, Daniela; Williams, W. T.; Yan, Haoheng; Yan, Weili; Yang, Lili; Yang, Lin; Zemo, Jennifer; Zhong, Zhandong Don

doi:10.1208/s12248-022-00762-6

Cited by 6 publications

(3 citation statements)

References 14 publications

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“…Also, the BBB in the brain regulates drug diffusion inside the brain, in contrast to many other organs where medications in the systemic circulation readily diffuse. By its microstructure and transport proteins, BBB strictly controls the interchange of chemicals with systemic circulation . Bearing this fact in mind, we can say that the activity induced by lower concentrations is more logical to be considered for taking the studies further.…”

Section: Results and Discussionmentioning

confidence: 99%

“…By its microstructure and transport proteins, BBB strictly controls the interchange of chemicals with systemic circulation. 73 Bearing this fact in mind, we can say that the activity induced by lower concentrations is more logical to be considered for taking the studies further. The above observations were confirmed by probing the treated cells with TuJ1 antibody followed by imaging using the confocal microscope (Figure 8).…”

Section: Table 1 Ic50 Values Of G1 and G2mentioning

confidence: 99%

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Biological Evaluation of Graphene Quantum Dots and Nitrogen-Doped Graphene Quantum Dots as Neurotrophic Agents

Raghavan,

Radhakrishnan,

Soren

et al. 2023

ACS Appl. Bio Mater.

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Over time, developments in nano-biomedical research have led to the creation of a number of systems to cure serious illnesses. Tandem use of nano-theragnostics such as diagnostic and therapeutic approaches tailored to the individual disease treatment is crucial for further development in the field of biomedical advancements. Graphene has garnered attention in the recent times as a potential nanomaterial for tissue engineering and regenerative medicines owing to its biocompatibility among the several other unique properties it possesses. The zero-dimensional graphene quantum dots (GQDs) and their nitrogen-doped variant, nitrogen-doped GQDs (N-GQDs), have good biocompatibility, and optical and physicochemical properties. GQDs have been extensively researched owing to several factors such as their size, surface charge, and interactions with other molecules found in biological media. This work briefly elucidates the potential of electroactive GQDs as well as N-GQDs as neurotrophic agents. In vitro investigations employing the N2A cell line were used to evaluate the effectiveness of GQDs and N-GQDs as neurotrophic agents, wherein basic investigations such as SRB assay and neurite outgrowth assay were performed. The results inferred from immunohistochemistry followed by confocal imaging studies as well as quantitative real-time PCR (qPCR) studies corroborated those obtained from neurite outgrowth assay. We have also conducted a preliminary investigation of the pattern of gene expression for neurotrophic and gliotrophic growth factors using ex vivo neuronal and mixed glial cultures taken from the brains of postnatal day 2 mice pups. Overall, the studies indicated that GQDs and N-GQDs hold prospect as a framework for further development of neuroactive compounds for relevant central nervous system (CNS) purposes.

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Section: Results and Discussionmentioning

confidence: 99%

Section: Table 1 Ic50 Values Of G1 and G2mentioning

confidence: 99%

Biological Evaluation of Graphene Quantum Dots and Nitrogen-Doped Graphene Quantum Dots as Neurotrophic Agents

Raghavan,

Radhakrishnan,

Soren

et al. 2023

ACS Appl. Bio Mater.

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show abstract

“…Рассчитывали значения RFU для стандартов 300, 200 и 150 нг/мл, нормированные на значения RFU для стандарта 125 нг/мл (титры). Получен- Согласно полученным данным, наибольшая разность между титрами нигде не превысила MSR, что соответствует критерию приемлемости [15,17].…”

Section: прецизионностьunclassified

Development and Validation of the Cell-based Functional Method for Neutralizing Anti-adalimumab Antibodies Detection in Human Serum

Nikiforova,

Valouev,

Petrov

et al. 2024

Razrabotka i registraciâ lekarstvennyh sredstv

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Introduction. Adalimumab, a fully humanized monoclonal antibody, is a tumor necrosis factor (TNFα) inactivator that is used against a number of autoimmune diseases such as rheumatoid arthritis and other most common inflammatory arthropathies (ankylosing spondylitis, psoriatic arthritis). Despite the proven efficacy of adalimumab treatment, there is a risk of adverse events, tied up with the formation of anti-drug antibodies, including neutralizing antibodies. Currently, the evaluation and characterization of neutralizing antibodies has become an important part of clinical trials in the development of new drugs and biosimilars.Aim. The aim of this study is to develop and validate the cell-based functional method for neutralizing anti-adalimumab antibodies determination in human serum.Materials and methods. For determination of neutralizing anti-adalimumab antibodies, the cell line L-929 has been employed. L-929 is a cell line sensitive to the TNFα-mediated apoptosis; the neutralizing antibodies interact with adalimumab that leads to TNFα-mediated cytotoxicity. Cytotoxicity was measured using resazurin, an aromatic compound that is a redox indicator.Results and discussion. The developed method was validated for cut point, selectivity, sensitivity, precision, specificity and stability (short- and long-term). An important part of a method development for determining neutralizing antibodies is the selection of concentrations of TNFα (4 ng/ml) and adalimumab (250 ng/ml), as well as determining the minimum required dilution – this parameter is established as 1 : 20. Cut point was chosen as a «floating» cut point, and a correction factor (normalization factor) was determined equal to 0,86. The sensitivity of the developed method was estimated at 108,9 ng/ml of neutralizing anti-adalimumab antibodies.Conclusion. The obtained results can be applied for determining anti-adalimumab neutralizing antibodies in the assessment of the adalimumab immunogenicity, including clinical trials.

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Method validation of a bridging immunoassay in combination with acid-dissociation and bead treatment for detection of anti-drug antibody

Yang

Zhu

et al. 2023

Heliyon

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Anti-drug Antibody Sample Testing and Reporting Harmonization

Cited by 6 publications

References 14 publications

Biological Evaluation of Graphene Quantum Dots and Nitrogen-Doped Graphene Quantum Dots as Neurotrophic Agents

Biological Evaluation of Graphene Quantum Dots and Nitrogen-Doped Graphene Quantum Dots as Neurotrophic Agents

Development and Validation of the Cell-based Functional Method for Neutralizing Anti-adalimumab Antibodies Detection in Human Serum

Method validation of a bridging immunoassay in combination with acid-dissociation and bead treatment for detection of anti-drug antibody

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