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

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

Bioanalysis 2019 Jun 19;11(12):1129-1138. Epub 2019 Jul 19.

WuXi Apptec, Plainsboro, NJ 08536, USA.

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.

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http://dx.doi.org/10.4155/bio-2019-0131DOI Listing
June 2019

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