Briscoe Chad, Hughes Nicola, Hayes Roger, Islam Rafiq, Bennett Patrick, Stouffer Bruce, Cape Stephanie, Rhyne Paul, Beaver Chris, Charles Jessica St, Kakkanaiah Vellalore, Xu Allan, Caturla Maria Cruz, Spriggs Franklin, Tayyem Rabab, Barry Colin, Keyhani Anahita, Zimmer Jennifer, Couerbe Philippe, Warren Mark, Khadang Ardeshir, Bourdage James, Lindley Kathie, Williams Dave, Sheldon Curtis, Satterwhite Christina, Vija Jenifer, Yu Mathilde, Boulay Iohann, Stamatopoulos John, Lin Jenny, Estdale Sian, Thomas Eric, Dinan Andrew, MacNeill Robert, Xiao Yi Qun, Matassa Luca, Garofolo Wei, Savoie Natasha, Hristopoulos George, Xu Arron, Goodwin Lawrence, Awaiye Kayode, Ritzén Hanna, Bouhajib Mohammed, Marco Chantal Di, Savu Simona Rizea, Nehls Corey, Tabler Edward, Hays Amanda, Karnik Shane, Brown Michael, Lowes Steve, DuBey Ira, Kulagina Nadia, Lindsay John, Williard Clark, Wang Hao, Malone Michele, Wells Edward, Fang Xinping, Moussallie Marc
PRA Health Sciences, Lenexa, KS, USA.
BioPharma Services, 4000 Weston Road, North York, Toronto, M9L 3A2 Ontario, Canada.
Bioanalysis. 2019 Jun;11(12):1129-1138. doi: 10.4155/bio-2019-0131. Epub 2019 Jul 19.
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.
第12届海湾合作委员会封闭论坛于2018年4月9日在美国宾夕法尼亚州费城举行。国际生物分析合同研究组织的代表出席会议，以讨论生物分析特有的科学和监管问题。会议讨论的问题包括：关键试剂；寡核苷酸；分析证书；方法转移；高分辨率质谱；流式细胞术；近期涉及稳定性和非临床免疫原性的监管结果及案例研究。本文包含了这些主题讨论的结论和共识。
