16 th GCC Closed Forum: ICH M10 implementation; NGS, qPCR/dPCR, flow cytometry validation; tissue biomarkers; IS response; immunogenicity harmonization; bioanalytical industry status.

Autor: Zimmer J; Alturas Analytics, Moscow, Idaho, USA., Hays A; BioAgilytix, Durham, North Carolina, USA., Lester T; BioAgilytix, Durham, North Carolina, USA., Diaz M; Eurofins Viracor, BioPharma Services, Lenexa, Kansas, USA., Thomas E; Labcorp, Indianapolis, Indiana, USA., O'Dell M; Labcorp, Indianapolis, Indiana, USA., Hyer E; Labcorp, Madison, Wisconsin, USA., Tangri S; Navigate Biopharma, San Diego, California, USA., Dakappagari N; Navigate Biopharma, San Diego, California, USA., Yuan M; PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA., Lavelle A; PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA., Karnik S; Aliri Bioanalysis, Colorado Springs, Colorado, USA., Liu A; Resolian (Formally Alliance Pharma), Malvern, Pennsylvania, USA., Xu B; Accurant Biotech, Cranbury, New Jersey, USA., Sales K; Agilex Biolabs, Adelaide, Australia., Gorityala S; BioAgilytix, Durham, North Carolina, USA., Reynolds G; BioAgilytix, San Diego, California, USA., Sangster T; Celerion, Lincoln, Nebraska, USA., Franckaert D; CellCarta Biosciences, Montreal, Canada., Love I; Charles River Laboratories, Edinburgh, Tranent, UK., Patel V; Charles River Laboratories, Reno, Nevada, USA., Roberge M; CIRION BioPharma Research (a Cerba Research Company), Laval, Quebec, Canada., Lin J; CMIC, Hoffman Estates, Illinois, USA., Jerks E; Eurofins Pharma Bioanalytics, Lake St. Louis, Missouri, USA., Xu T; Frontage Laboratory, Exton, Pennsylvania, USA., Garofolo W; GCC, Toronto, Ontario, Canada., Nadarajah S; GCC, Toronto, Ontario, Canada., Kernstock R; ICON plc, Whitesboro, New York, USA., Dufield D; KCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA., Ambrose D; KCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA., Warrino D; KCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA., Luna M; KCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA., Marco CD; Pharma Medica Research, Mississauga, Ontario, Canada., Tudoroniu A; Pharma Serv International, Bucharest, Romania., Iordachescu A; Pharma Serv International, Bucharest, Romania., Sanghvi M; Pharmaron, Germantown, Maryland, USA., Barton H; PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA., Brown M; Q2 Solutions Durham, North Carolina, USA., Hoffpauir B; Smithers, Gaithersburg, Maryland, USA., Rocha A; Smithers, Ewing, New Jersey, USA., Dong K; United-Power Pharma Tech Co., Beijing, China., Yamashita J; WuXi AppTec, Plainsboro, NJ, USA.
Jazyk: angličtina
Zdroj: Bioanalysis [Bioanalysis] 2024 Jun 02; Vol. 16 (11), pp. 505-517. Date of Electronic Publication: 2024 Jun 12.
DOI: 10.1080/17576180.2024.2342691
Abstrakt: The 16th GCC Closed Forum was held in Orlando, FL, USA, on 23 June 2023. Representatives from international bioanalytical Contract Research Organizations were in attendance in order to discuss scientific and regulatory issues specific to bioanalysis. The issues discussed at the meeting included: IS response, flow cytometry, changes to the bioanalytical industry, NGS assays, biomarker assay for tissues, dPCR validation, immunogenicity harmonization and ICH M10 implementation. Conclusions and consensus from discussions of these topics are included in this article.
Databáze: MEDLINE