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

doi:10.1080/17576180.2024.2342691

. 2024 Jun 2;16(11):505-517.

doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12.

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

Jennifer Zimmer¹, Amanda Hays², Todd Lester², Manisha Diaz³, Eric Thomas⁴, Mark O'Dell⁴, Elizabeth Hyer⁵, Shabnam Tangri⁶, Naveen Dakappagari⁶, Moucun Yuan⁷, Amy Lavelle⁷, Shane Karnik⁸, Aihua Liu⁹, Bin Xu¹⁰, Kurt Sales¹¹, Shashank Gorityala², Gregory Reynolds¹², Tim Sangster¹³, Dean Franckaert¹⁴, Iain Love¹⁵, Vimal Patel¹⁶, Martin Roberge¹⁷, Jenny Lin¹⁸, Erik Jerks¹⁹, Tao Xu²⁰, Wei Garofolo²¹, Sankeetha Nadarajah²¹, Robert Kernstock²², Dawn Dufield²³, David Ambrose²³, Dominic Warrino²³, Marsha Luna²³, Chantal Di Marco²⁴, Ariana Tudoroniu²⁵, Adriana Iordachescu²⁵, Mitesh Sanghvi²⁶, Hollie Barton⁷, Michael Brown²⁷, Brian Hoffpauir²⁸, Agostinho Rocha²⁹, Kelly Dong³⁰, Jim Yamashita³¹

Affiliations

¹ Alturas Analytics, Moscow, Idaho, USA.
² BioAgilytix, Durham, North Carolina, USA.
³ Eurofins Viracor, BioPharma Services, Lenexa, Kansas, USA.
⁴ Labcorp, Indianapolis, Indiana, USA.
⁵ Labcorp, Madison, Wisconsin, USA.
⁶ Navigate Biopharma, San Diego, California, USA.
⁷ PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
⁸ Aliri Bioanalysis, Colorado Springs, Colorado, USA.
⁹ Resolian (Formally Alliance Pharma), Malvern, Pennsylvania, USA.
¹⁰ Accurant Biotech, Cranbury, New Jersey, USA.
¹¹ Agilex Biolabs, Adelaide, Australia.
¹² BioAgilytix, San Diego, California, USA.
¹³ Celerion, Lincoln, Nebraska, USA.
¹⁴ CellCarta Biosciences, Montreal, Canada.
¹⁵ Charles River Laboratories, Edinburgh, Tranent, UK.
¹⁶ Charles River Laboratories, Reno, Nevada, USA.
¹⁷ CIRION BioPharma Research (a Cerba Research Company), Laval, Quebec, Canada.
¹⁸ CMIC, Hoffman Estates, Illinois, USA.
¹⁹ Eurofins Pharma Bioanalytics, Lake St. Louis, Missouri, USA.
²⁰ Frontage Laboratory, Exton, Pennsylvania, USA.
²¹ GCC, Toronto, Ontario, Canada.
²² ICON plc, Whitesboro, New York, USA.
²³ KCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA.
²⁴ Pharma Medica Research, Mississauga, Ontario, Canada.
²⁵ Pharma Serv International, Bucharest, Romania.
²⁶ Pharmaron, Germantown, Maryland, USA.
²⁷ Q2 Solutions Durham, North Carolina, USA.
²⁸ Smithers, Gaithersburg, Maryland, USA.
²⁹ Smithers, Ewing, New Jersey, USA.
³⁰ United-Power Pharma Tech Co., Beijing, China.
³¹ WuXi AppTec, Plainsboro, NJ, USA.

PMID: 38864397
PMCID: PMC11299793
DOI: 10.1080/17576180.2024.2342691

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

Jennifer Zimmer et al. Bioanalysis. 2024.

. 2024 Jun 2;16(11):505-517.

doi: 10.1080/17576180.2024.2342691. Epub 2024 Jun 12.

Authors

Affiliations

¹ Alturas Analytics, Moscow, Idaho, USA.
² BioAgilytix, Durham, North Carolina, USA.
³ Eurofins Viracor, BioPharma Services, Lenexa, Kansas, USA.
⁴ Labcorp, Indianapolis, Indiana, USA.
⁵ Labcorp, Madison, Wisconsin, USA.
⁶ Navigate Biopharma, San Diego, California, USA.
⁷ PPD Clinical Research, Thermo Fisher Scientific, Richmond, Virginia, USA.
⁸ Aliri Bioanalysis, Colorado Springs, Colorado, USA.
⁹ Resolian (Formally Alliance Pharma), Malvern, Pennsylvania, USA.
¹⁰ Accurant Biotech, Cranbury, New Jersey, USA.
¹¹ Agilex Biolabs, Adelaide, Australia.
¹² BioAgilytix, San Diego, California, USA.
¹³ Celerion, Lincoln, Nebraska, USA.
¹⁴ CellCarta Biosciences, Montreal, Canada.
¹⁵ Charles River Laboratories, Edinburgh, Tranent, UK.
¹⁶ Charles River Laboratories, Reno, Nevada, USA.
¹⁷ CIRION BioPharma Research (a Cerba Research Company), Laval, Quebec, Canada.
¹⁸ CMIC, Hoffman Estates, Illinois, USA.
¹⁹ Eurofins Pharma Bioanalytics, Lake St. Louis, Missouri, USA.
²⁰ Frontage Laboratory, Exton, Pennsylvania, USA.
²¹ GCC, Toronto, Ontario, Canada.
²² ICON plc, Whitesboro, New York, USA.
²³ KCAS Bioanalytical & Biomarker Services, Olathe, Kansas, USA.
²⁴ Pharma Medica Research, Mississauga, Ontario, Canada.
²⁵ Pharma Serv International, Bucharest, Romania.
²⁶ Pharmaron, Germantown, Maryland, USA.
²⁷ Q2 Solutions Durham, North Carolina, USA.
²⁸ Smithers, Gaithersburg, Maryland, USA.
²⁹ Smithers, Ewing, New Jersey, USA.
³⁰ United-Power Pharma Tech Co., Beijing, China.
³¹ WuXi AppTec, Plainsboro, NJ, USA.

PMID: 38864397
PMCID: PMC11299793
DOI: 10.1080/17576180.2024.2342691

Abstract

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.

Keywords: CRO; ICH M10; IS response; NGS assay; bioanalysis; biomarker assay; dPCR validation; flow cytometry; immunogenicity harmonization.

PubMed Disclaimer

Conflict of interest statement

The authors have no competing interests or relevant affiliations with any organization or entity with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, stock ownership or options and expert testimony.

Cited by

Recommendations on biomarker assay validation (BAV) in tissues by GCC.
Yuan M, Liu A, Xu B, Sales K, Karnik S, Voelker T, Salha D, Zimmer J, O'Dell M, Gorityala S, Hays A, Lester T, Reynolds G, Tary-Lehmann M, Yu M, Roberge M, Malone K, Patel V, Love I, Lin J, Diaz M, Xu T, Garofolo W, McGregor J, Leskovar A, Kernstock R, Pellerin M, Brown M, Spytko A, Lowes S, Ambrose D, Dufield D, Kane C, Veeramachaneni R, Luna M, Warrino D, Dwivedi V, Xu A, Hyer E, Iles T, Majumdar R, Sikkema D, Thomas E, Carlsson A, Dakappagari N, Riccitelli N, Marco CD, Bouhajib M, Iordachescu A, Sanghvi M, Barton H, Lavelle A, Dompkowski E, Rundlett S, Matys K, Sangster T, Turksma A, Gu W, Liu J, Hoffpauir B, Rocha A, Pirro J, Bergeron J, O'Brien K, Fang X, Dong K, Yamashita J. Yuan M, et al. Bioanalysis. 2025 Apr;17(7):429-438. doi: 10.1080/17576180.2025.2471243. Epub 2025 Apr 18. Bioanalysis. 2025. PMID: 40248960

References

1. Premkumar N, Lowes S, Jersey J, et al. Formation of a Global Contract Research Organization Council for Bioanalysis. Bioanalysis. 2010;2(11):1797–1800. doi: 10.4155/bio.10.165 - DOI - PubMed
1. Breda M, Garofolo F, Caturla MC, et al. Conference Report: The 3^rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum. Bioanalysis. 2011;3(24):2721–2727. doi: 10.4155/bio.11.242 - DOI - PubMed
1. Lowes S, Jersey J, Shoup R, et al. Conference Report: 4^th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover. Bioanalysis. 2012;4(7):763–768. doi: 10.4155/bio.12.48 - DOI - PubMed
1. Nicholson R, Lowes S, Caturla MC, et al. Conference Report: 6^th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Bioanalysis. 2012;4(19):2335–2342. doi: 10.4155/bio.12.213 - DOI - PubMed
1. Rocci M, Lowes S, Shoup R, et al. 7^th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing. Bioanalysis. 2014;6(20):2713–2720. doi: 10.4155/bio.14.231 - DOI - PubMed

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[1] Premkumar N, Lowes S, Jersey J, et al. Formation of a Global Contract Research Organization Council for Bioanalysis. Bioanalysis. 2010;2(11):1797–1800. doi: 10.4155/bio.10.165 - DOI - PubMed

[2] Premkumar N, Lowes S, Jersey J, et al. Formation of a Global Contract Research Organization Council for Bioanalysis. Bioanalysis. 2010;2(11):1797–1800. doi: 10.4155/bio.10.165 - DOI - PubMed

[3] Breda M, Garofolo F, Caturla MC, et al. Conference Report: The 3^rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum. Bioanalysis. 2011;3(24):2721–2727. doi: 10.4155/bio.11.242 - DOI - PubMed

[4] Breda M, Garofolo F, Caturla MC, et al. Conference Report: The 3^rd Global CRO Council for Bioanalysis at the International Reid Bioanalytical Forum. Bioanalysis. 2011;3(24):2721–2727. doi: 10.4155/bio.11.242 - DOI - PubMed

[5] Lowes S, Jersey J, Shoup R, et al. Conference Report: 4^th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover. Bioanalysis. 2012;4(7):763–768. doi: 10.4155/bio.12.48 - DOI - PubMed

[6] Lowes S, Jersey J, Shoup R, et al. Conference Report: 4^th Global CRO Council for Bioanalysis: coadministered drugs stability, EMA/US FDA Guidelines, 483s and Carryover. Bioanalysis. 2012;4(7):763–768. doi: 10.4155/bio.12.48 - DOI - PubMed

[7] Nicholson R, Lowes S, Caturla MC, et al. Conference Report: 6^th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Bioanalysis. 2012;4(19):2335–2342. doi: 10.4155/bio.12.213 - DOI - PubMed

[8] Nicholson R, Lowes S, Caturla MC, et al. Conference Report: 6^th GCC focus on LBA: critical reagents, positive controls and reference standards; specificity for endogenous compounds; biomarkers; biosimilars. Bioanalysis. 2012;4(19):2335–2342. doi: 10.4155/bio.12.213 - DOI - PubMed

[9] Rocci M, Lowes S, Shoup R, et al. 7^th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing. Bioanalysis. 2014;6(20):2713–2720. doi: 10.4155/bio.14.231 - DOI - PubMed

[10] Rocci M, Lowes S, Shoup R, et al. 7^th GCC Insights: incurred samples use; fit-for-purpose validation, solution stability, electronic laboratory notebook and hyperlipidemic matrix testing. Bioanalysis. 2014;6(20):2713–2720. doi: 10.4155/bio.14.231 - DOI - PubMed

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

Affiliations

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

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