Bioanalysis

  • Bioanalysis
  • Multiplexed Cytokine Comparison Across Two Species Dosed with the Same Drug

    Detection of Plasma Cells and their Precursors in Bone Marrow and Peripheral Blood

    Evaluating Cytokine Data in Nonhuman Primate Safety Assessment Studies: A Correlation to Toxicity Outcomes

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    We are often asked about the advantages of working with an integrated CRO/CDMO.

    In 2021, you did incredible things — and we are grateful to have been part of your journey.

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    Altasciences offers specialized services in flow cytometry, a highly sensitive system

    Bioanalytical Developments for the Analysis of Antisense Oligonucleotides

    Preclinical Strategies in Rodent Studies Using Volumetric Absorptive Microsampling (VAMS®)

    Regulatory guidelines focusing on immunogenicity assays for clinical studies are not all applicable to nonclinical requirements and their unique challenges. While we have a full understanding of regulatory requirements for clinical studies, the lack of regulatory documents addressing the particular needs of nonclinical immunogenicity studies has contributed to less consensus on appropriate immunogenicity testing strategies and validation parameters. This, by extension, has led to different approaches being adopted by the drug development industry.

    In Issue 20 of The Altascientist, we review and share some of Altasciences’ approaches to validating immunogenicity assays for nonclinical and clinical studies, including insight on:

    • how to plan for immunogenicity assessments 
    • drug tolerance 
    • positive control
    • managing variability
    • critical reagent validation and changes 
    • neutralizing anti-drug antibodies (NAbs)

     

     

    Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay

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