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

Autor: Ira DuBey, Marc Moussallie, Nadia Kulagina, Dave Williams, Corey Nehls, Rabab Tayyem, Michael E. Brown, Wei Garofolo, Edward Tabler, Philippe Couerbe, Ardeshir Khadang, John Lindsay, Michele Malone, Paul Rhyne, Anahita Keyhani, Mark Warren, Jennifer Zimmer, John Stamatopoulos, Sian Estdale, Clark V. Williard, Bruce Stouffer, Eric Thomas, Mathilde Yu, Rafiq Islam, George Hristopoulos, Simona Rizea Savu, Robert MacNeill, Edward Wells, Jenny Lin, Hanna Ritzén, Iohann Boulay, Natasha Savoie, Kayode Awaiye, Vellalore Kakkanaiah, Shane Karnik, Christina Satterwhite, Curtis Sheldon, Amanda Hays, Chad Briscoe, Kathie Lindley, Colin Barry, Yi Qun Xiao, Andrew Dinan, Allan Xu, Luca Matassa, Arron Xu, Lawrence Goodwin, Steve Lowes, Jessica St Charles, Chantal Di Marco, Mohammed Bouhajib, Maria Cruz Caturla, Nicola Hughes, Patrick Bennett, Jenifer Vija, Stephanie Cape, Roger Hayes, Hao Wang, Xinping Fang, James Bourdage, Franklin Spriggs, Chris Beaver
Rok vydání: 2019
Předmět:
Zdroj: Bioanalysis. 11(12)
ISSN: 1757-6199
Popis: 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.
Databáze: OpenAIRE