All immunogenicity assessments present specific challenges. As a contract research organization (CRO), a major challenge we face is related to the lack of harmonization and standardization. Find out more in this editorial from a team at LGC (Cambridgeshire, UK).
Webinar live date: Thursday 10 January 2018 07:00 [PST] 10:00 [EST] 15:00 [GMT]. In this free panel discussion, our experts will provide insights into their own research with immunogenicity including the challenges they have had to overcome, key trends they have seen and their future outlook of the development of this field.
Webinar live date: Tuesday 8 January 2019 07:00 [PST] 10:00 [EST] 15:00 [GMT]. Exploring the challenges a lack of industry standardization presents for CRO project managers and scientists as well as biopharma and biotech companies.
Webinar live date: Monday 7 January 2019 07:00 [PST] 10:00 [EST] 15:00 [GMT]. This webinar will give an overview of immunogenicity assay development, explore the impact of anti-drug antibodies on bioanalysis and review relevant case studies discussing in-study cut-point and tolerance.
In this interview Alex Hawes (LGC; Cambridge, UK) discusses the topic of immunogenicity. She explains how she developed her first anti-drug antibody analytical method and the platforms LGC use in their immunogenicity sector.
Dr Bonner serves as a scientific resource and technical advisor for both clients and internal…
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.
In this interview, Joao discusses the molecules and products he reviews and how important it is to understand how they affect efficacy and safety in patients.
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Poster: novel approach to immunogenicity testing for therapeutics with high prevalence of pre-existing antibodies
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.