Platform Usage to Support Advanced Drug Modalities

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Technology platforms not typically used for regulated bioanalysis are now utilized more frequently to support cell and gene therapy programs. Flow cytometry, ELISpot and quantitative…

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ADA Assessment And Detection

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Cell therapies are emerging and evolving as promising therapies for a variety of disease indications. The ability to detect anti-drug antibodies (ADA) is important for…

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Strategies for Overcoming Drug Interference in Immunogenicity Assessment

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Circulating drug can often interfere in the detection of anti-drug antibodies (ADAs). Therefore, it is imperative to develop bioanalytical assays that are able to reliably…

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Total Bioanalytical Support for Antibody−Drug Conjugates (ADCs)

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Antibody−drug conjugates (ADCs) typically contain a small molecule toxin (payload) linked to an antibody framework. The intent is to deliver the toxin in a targeted…

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PK Assessment for Advanced Modalities (Cell & Gene Therapies)

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The last few decades have seen a surge of new cell and gene therapies in drug development pipelines. The bioanalytical support for these complex modalities…

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Assessing Cellular Immunogenicity via ELISpot

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As therapeutic modalities have become more complex, such as cell and gene therapies, so too have the bioanalytical methods become more complex for characterizing these…

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Total Antibody Assays for AAV-Based Gene Therapies – To Bridge or Not to Bridge

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Assessing humoral immunogenicity is an interesting challenge for adeno-associated virus (AAV)-based gene therapies. While most people are concerned about how to deal with pre-existing antibodies…

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Molecular Methods for Gene Therapies (GMP)

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In association with Oxford Global, this webinar features an expert panel to discuss our work with potency assays for gene and cell therapy products. As…

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