Details der Publikation - 12th GCC Closed Forum

12th GCC Closed Forum : critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

The 12th GCC Closed Forum was held in Philadelphia, PA, USA, on 9 April 2018. 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: critical reagents; oligonucleotides; certificates of analysis; method transfer; high resolution mass spectrometry; flow cytometry; recent regulatory findings and case studies involving stability and nonclinical immunogenicity. Conclusions and consensus from discussions of these topics are included in this article.

Medienart:	E-Artikel

Erscheinungsjahr:	2019
Erschienen:	2019

Enthalten in:	Zur Gesamtaufnahme - volume:11
Enthalten in:	Bioanalysis - 11(2019), 12 vom: 01. Juni, Seite 1129-1138

Sprache:	Englisch

Beteiligte Personen:	Briscoe, Chad [VerfasserIn] Hughes, Nicola [VerfasserIn] Hayes, Roger [VerfasserIn] Islam, Rafiq [VerfasserIn] Bennett, Patrick [VerfasserIn] Stouffer, Bruce [VerfasserIn] Cape, Stephanie [VerfasserIn] Rhyne, Paul [VerfasserIn] Beaver, Chris [VerfasserIn] Charles, Jessica St [VerfasserIn] Kakkanaiah, Vellalore [VerfasserIn] Xu, Allan [VerfasserIn] Caturla, Maria Cruz [VerfasserIn] Spriggs, Franklin [VerfasserIn] Tayyem, Rabab [VerfasserIn] Barry, Colin [VerfasserIn] Keyhani, Anahita [VerfasserIn] Zimmer, Jennifer [VerfasserIn] Couerbe, Philippe [VerfasserIn] Warren, Mark [VerfasserIn] Khadang, Ardeshir [VerfasserIn] Bourdage, James [VerfasserIn] Lindley, Kathie [VerfasserIn] Williams, Dave [VerfasserIn] Sheldon, Curtis [VerfasserIn] Satterwhite, Christina [VerfasserIn] Vija, Jenifer [VerfasserIn] Yu, Mathilde [VerfasserIn] Boulay, Iohann [VerfasserIn] Stamatopoulos, John [VerfasserIn] Lin, Jenny [VerfasserIn] Estdale, Sian [VerfasserIn] Thomas, Eric [VerfasserIn] Dinan, Andrew [VerfasserIn] MacNeill, Robert [VerfasserIn] Xiao, Yi Qun [VerfasserIn] Matassa, Luca [VerfasserIn] Garofolo, Wei [VerfasserIn] Savoie, Natasha [VerfasserIn] Hristopoulos, George [VerfasserIn] Xu, Arron [VerfasserIn] Goodwin, Lawrence [VerfasserIn] Awaiye, Kayode [VerfasserIn] Ritzén, Hanna [VerfasserIn] Bouhajib, Mohammed [VerfasserIn] Marco, Chantal Di [VerfasserIn] Savu, Simona Rizea [VerfasserIn] Nehls, Corey [VerfasserIn] Tabler, Edward [VerfasserIn] Hays, Amanda [VerfasserIn] Karnik, Shane [VerfasserIn] Brown, Michael [VerfasserIn] Lowes, Steve [VerfasserIn] DuBey, Ira [VerfasserIn] Kulagina, Nadia [VerfasserIn] Lindsay, John [VerfasserIn] Williard, Clark [VerfasserIn] Wang, Hao [VerfasserIn] Malone, Michele [VerfasserIn] Wells, Edward [VerfasserIn] Fang, Xinping [VerfasserIn] Moussallie, Marc [VerfasserIn]

Links:	Volltext

Themen:	CRO Certificate of analysis Critical reagents Flow cytometry GCC HRMS Indicators and Reagents Journal Article Method transfer Oligonucleotides Regulatory findings Stability and immunogenicity

Anmerkungen:	Date Completed 13.12.2019 Date Revised 17.12.2019 published: Print-Electronic Citation Status MEDLINE

doi:	10.4155/bio-2019-0131

funding:
Förderinstitution / Projekttitel:

PPN (Katalog-ID):	NLM299321940

Internformat


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700	1		\|a Goodwin, Lawrence \|e verfasserin \|4 aut
700	1		\|a Awaiye, Kayode \|e verfasserin \|4 aut
700	1		\|a Ritzén, Hanna \|e verfasserin \|4 aut
700	1		\|a Bouhajib, Mohammed \|e verfasserin \|4 aut
700	1		\|a Marco, Chantal Di \|e verfasserin \|4 aut
700	1		\|a Savu, Simona Rizea \|e verfasserin \|4 aut
700	1		\|a Nehls, Corey \|e verfasserin \|4 aut
700	1		\|a Tabler, Edward \|e verfasserin \|4 aut
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700	1		\|a Moussallie, Marc \|e verfasserin \|4 aut
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12th GCC Closed Forum : critical reagents; oligonucleotides; CoA; method transfer; HRMS; flow cytometry; regulatory findings; stability and immunogenicity

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