In this report from Bioanalysis, the authors summaries key points discussed the Bioanalysis Zone panel discussion filmed during the 12th Workshop on Recent Issues in Bioanalysis which focused on the topic of new technology integration into bioanalytical workflows.
2018 White Paper on Recent Issues in Bioanalysis: focus on immunogenicity assays by hybrid LBA/LCMS and regulatory feedback (Part 2 – PK, PD & ADA assays by hybrid LBA/LCMS & regulatory agencies’ inputs on bioanalysis, biomarkers and immunogenicity)
This part of the 2018 White Paper published in Bioanalysis focuses on the recommendations for PK, PD and ADA assays by hybrid LBA/LCMS and regulatory agencies’ input.
Arno Kromminga and Lydia Michaut will discuss the strategies and challenges of immunogenicity assessment for gene therapy compounds.
2018 White Paper on Recent Issues in Bioanalysis: focus on flow cytometry, gene therapy, cut points and key clarifications on BAV (Part 3 – LBA/cell-based assays: immunogenicity, biomarkers and PK assays)
This part of the 2018 White Paper published in Bioanalysis covers the recommendations for large molecule bioanalysis, biomarkers and immunogenicity using LBA and cell-based assays.
The speakers from our January panel discussion on immunogenicity answer further questions from the live event
In this interview, Michael Schwenkert (Bio-Rad Laboratories) describes the challenges for development of CAR-T cell therapies that can be addressed using anti-idiotypic antibodies.
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 available to view on demand. 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 available to view on demand. Exploring the challenges a lack of industry standardization presents for CRO project managers and scientists as well as biopharma and biotech companies.
Webinar available to view on demand. 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.