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