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
Five Things You Need to Know About Partnering with an Integrated CRO/CDMO
We are often asked about the advantages of working with an integrated CRO/CDMO.
2021 Year in Review
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In 2021, you did incredible things — and we are grateful to have been part of your journey. Four Reasons to Choose Altasciences as Your Flow Cytometry Partner
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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®)
ISSUE NO. 20 — Validation of Immunogenicity AssaysRegulatory 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:
Using Anti-Drug-Antibody Screening Assay to Resolve Selectivity Issues in Toxicokinetic Ligand-Binding Assay
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