Browsing: immunogenicity

Immunogenicity Bz KCas image
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Immunogenicity is the patient’s ability to generate antibodies, specific to the ‘dosed protein therapeutic’. In this blog post, Franklin Spriggs (KCAS; KS, USA) explains the importance of antibody-drug antibody assays and how data can be used towards safety profiles.

Immunogenicity Spotlight survey 1
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To kick-start this our special focus on immunogencity, we wanted to hear your thoughts on the topic. Complete our short survey on immunogencity and be the first to receive our informative infographic collated from the survey results.

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).