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Article Abstract

The 17th GCC Closed Forum was held in San Antonio, TX, USA, on 10 May 2024. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The topics discussed at the meeting included integrative bioanalysis, patient-centric sampling, emerging technologies, data integrity, sample reconciliation efforts, discrepancies of ELISpot data, cross-validation harmonization, ultrasensitive platforms for immunogenicity assays, remote regulatory assessments, shedding assays by qPCR/dPCR, and biomarker assays. Conclusions and consensus from discussions of these topics are included in this article.

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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC12367079PMC
http://dx.doi.org/10.1080/17576180.2025.2529119DOI Listing

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