机译：2020白皮书关于生物分析的最近问题：BAV指导，CLSI H62，BiothyAptics稳定性，平行症测试，Cytof和监管反馈（第2A号 - 关于生物治疗稳定性的建议，PK LBA调节生物分析，生物标志物测定，细胞计数验证和创新部分2B-incormation 代理商对生物分析，生物标志物，免疫原性，基因和细胞疗法和疫苗的输入）
Incyte Res Inst Wilmington DE USA;
Bristol Myers Squibb Lawrenceville NJ USA;
Genentech Inc San Francisco CA USA;
Regeneron Pharmaceut Tarrytown NY USA;
Novartis Basel Switzerland;
Boston Pharmaceut Cambridge MA USA;
US FDA Silver Spring MD USA;
AstraZeneca R&
D Integrated Bioanal Clin Pharmacol &
Safety Sci Gaithersburg MD USA;
BRI Vancouver BC Canada;
Celerion Lincoln NE USA;
Roche Innovat Ctr Roche Pharma Res &
Early Dev Munich Germany;
Pfizer Andover MA USA;
Japan MHLW NIHS Tokyo Japan;
Regeneron Pharmaceut Tarrytown NY USA;
GlaxoSmithKline Stevenage Herts England;
Novartis Basel Switzerland;
US FDA Silver Spring MD USA;
Boehringer Ingelheim GmbH &
Co KG Ridgefield CT USA;
Pfizer Groveland MA USA;
Sanofi Framingham MA USA;
Regeneron Pharmaceut Tarrytown NY USA;
Pfizer Medford MA USA;
Takeda Cambridge MA USA;
Pfizer Groton CT USA;
Genentech Inc San Francisco CA USA;
US FDA Silver Spring MD USA;
EMD Serono Andover MA USA;
GlaxoSmithKline Collegeville PA USA;
Roche Innovat Ctr Roche Pharma Res &
Early Dev Munich Germany;
Regeneron Pharmaceut Tarrytown NY USA;
Genentech Inc San Francisco CA USA;
US FDA Silver Spring MD USA;
Charles River Reno NV USA;
CFABS Montreal PQ Canada;
Hlth Canada Ottawa ON Canada;
UK MHRA London England;
EMA London England;
Genentech Inc San Francisco CA USA;
US FDA Silver Spring MD USA;
Eurofins Bioanal Serv Abingdon Oxon England;
GSK Vaccines Rockville MD USA;
Navigate San Diego CA USA;
Covance Meyrin Switzerland;
Genentech Inc San Francisco CA USA;
F Hoffmann La Roche Basel Switzerland;
CFABS Montreal PQ Canada;
Bristol Myers Squibb Mt Laurel NJ USA;
Navigate San Diego CA USA;
Q2 Solut Marietta GA USA;
F Hoffmann La Roche Basel Switzerland;
GlaxoSmithKline Philadelphia PA USA;
Takeda Cambridge MA USA;
Bristol Myers Squibb Holland PA USA;
Genentech Inc San Francisco CA USA;
Bluebird Bio Cambridge MA USA;
GSK Vaccines Rockville MD USA;
Navigate San Diego CA USA;
Merck Kenilworth NJ USA;
US FDA Silver Spring MD USA;
US FDA Silver Spring MD USA;
Hlth Canada Ottawa ON Canada;
US FDA Silver Spring MD USA;
UK MHRA London England;
Brazil ANVISA Brasilia DF Brazil;
US FDA Silver Spring MD USA;
US FDA Silver Spring MD USA;
Hlth Canada Ottawa ON Canada;
US FDA Silver Spring MD USA;
US FDA Silver Spring MD USA;
Hlth Canada Ottawa ON Canada;
UK MHRA NIBSC London England;
UK MHRA London England;
Japan MHLW NIHS Tokyo Japan;
US FDA Silver Spring MD USA;
US FDA Silver Spring MD USA;
US FDA Silver Spring MD USA;
Hlth Canada Ottawa ON Canada;
Norwegian Med Agcy NoMA Oslo Norway;
US FDA Silver Spring MD USA;
US FDA Silver Spring MD USA;
Hlth Canada Ottawa ON Canada;
bioanalysis; biomarkers; cell therapy; gene therapy; immunogenicity; vaccine; WRIB;
机译：2019年白皮书在生物分析中最近的问题：FDA免疫原性指导，基因治疗，关键试剂，生物标志物和流式细胞术验证（第3部分 - 2019年FDA免疫原性指导，基因治疗生物分析挑战，批判试剂管理的策略，BioMarker测定验证， 流式细胞仪验证和CLSI H62）
机译：2018年白皮书在生物分析中最近的问题：杂交LBA / LCMS和监管反馈的关注 - 杂交LBA / LCMS的免疫性测定（混合LBA / LCMS和监管机构对生物分析，生物标志物和免疫原性的投入的第2次PK，PD和ADA测定）
机译：2018年白皮书关于生物分析的最近问题：专注于流动细胞计，基因治疗，切割点和基于BAV的关键澄清（第3-LBA /细胞基础测定：免疫原性，生物标志物和PK测定）
机译：2018年白皮书近期生物分析中的问题：专注于流式细胞术，基因治疗，切割点和BAV的关键澄清（第3-17-17-1-基于第3-1ba / Cell的测定：免疫原性，生物标志物和PK测定）
