Browsing: immunogenicity

Immunogenicity Novel Approach to Immunogenicity Testing for Therapeutics
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Developing Immunogenicity methods for patient populations with a high prevalence of pre-existing antibodies pose challenges that are difficult to validate. Care must be taken to acknowledge these risks during development of screening strategy and method development. In this case study, the therapeutic consisted of two domains (X-Y) in which domain X has homology to a childhood vaccine with known immunogenicity in ≥90% of the U.S. population. Screening strategy includes domain specificity testing using inhibition by excess of each domain for confirmatory cut point determination.

Conference reports wrib conference report thumbnail
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In this conference report we discuss our highlights from the 12th Workshop on Recent Issues in Bioanalysis – Where Regulators and Industry Convene (WRIB; Philadelphia, USA; 9–13 April).

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Bioanalysis Zone and Bioanalysis welcome unsolicited submissions to both the journal and website!

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Issue 24 of Bioanalysis volume 9 is now available, including part three of the White Paper on recent issues in bioanalysis, an editorial on microspray and microflow liquid chromatography and a review on the bioanalytical methods for the detection of antidiabetic drug.

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Issue 22 of Bioanalysis volume 9 is now available, including an editorial article on immunogenicity and biomarkers, a conference report from the 8th Japan Bioanalysis Forum and the 2017 White Paper on Recent issues in Bioanalysis.