实验室空间和仪器设备

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实验室空间和仪器设备

研究目的

Non-GLP 生物分析团队分为中国(上海、苏州、南京和南通)和美国(新泽西)五地,实验室包括仪器室和装配了黄光灯的样品处理室,以防止化合物的光降解。实验室搭建了多种先进的液质联用(LC-MS/MS)平台,满足客户不同阶段的分析需求。质谱仪类型覆盖范围广,如 Sciex 公司多代三重四极杆质谱仪,Waters 公司的 XeVo G2 QToF 和 Vion QToF 质谱仪,以 及 ThermoFisher 公 司 的 Orbitrap Q-ExactiveTM Plus 和 Q-ExactiveTM HF 系统。这些质谱系统与 Waters UPLC,Shimadzu UHPLC 等超高效液相色谱系统联用。针对筛选阶段的体外样品分析配备了高通量自动进样器如 CTC、ADDA 等;针对大分子的 LBA 分析,配备了 Molecular Devices 公司 SpectraMax M5/M5e 仪器和 MSD 公司 QuickPlex SQ120 仪器等。此外,我们拥有多套自动化系统如 HP D300e 仪器和 Hamilton Microlab STARTM 自动化液体处理工作站等,以支持样品快速处理。

Non-GLP 生物分析仪器室

样品处理室(装配了黄光灯用以避免样品中待测化合物的光降解)

Waters ACQUITY UPLC
Waters ACQUITY UPLC
Shimadzu Nexera UHPLC LC-30A
Shimadzu Nexera UHPLC LC-30A

Non-GLP 生物分析实验室部分高效液相色谱仪

CTC Analytics AG PAL3 Autosampler
CTC Analytics AG PAL3 Autosampler
Apricot Designs Dual Arm
Apricot Designs Dual Arm

Non-GLP 生物分析实验室部分高通量进样仪器

Sciex Triple Quad™ 6500+
Sciex Triple Quad™ 6500+
Sciex Triple Quad™ 7500
Sciex Triple Quad™ 7500

Non-GLP 生物分析实验室部分三重四极杆质谱仪

Waters Vion™ Qtof
Waters Vion™ QTof
ThermoScientific Orbitrap Q-Exactive™ HF
ThermoScientific Orbitrap Q-Exactive™ HF

Non-GLP 生物分析实验室部分高分辨质谱仪

Molecular Devices SpectraMax M5e
Molecular Devices SpectraMax M5e
MESO QuickPlex SQ 120
MESO QuickPlex SQ 120

Non-GLP 生物分析实验室部分配体结合分析仪器

HP D300e
HP D300e
Hamilton Microlab STAR™
Hamilton Microlab STAR™

Non-GLP 生物分析实验室部分自动化仪器设备

参考文献
1. Li W. et al. Handbook of LC-MS Bioanalysis: Best Practices, Experimental Protocols, and Regulations (WILEY, 2013)
2. Jemal M. et al. LC-MS development strategies for quantitative bioanalysis. Curr Drug Metab. 7. 491-502 (2006)
3. Shou W. et al. Recent development in software and automation tools for high-throughput discovery bioanalysis. Bioanalysis. 4.1097-1109 (2012)
4. Janiszewski J. et al. Development of a high-speed, multiplexed sample-delivery instrument for LC-MS/MS bioanalysis. 4.1039-1056 (2012)
5. FDA: Guidance for Industry, Bioanalytical Validation Method (2018)
6. EMA: ICH Guideline M10 on Bioanalytical Method Validation (2019 Draft)
7. OECD: Principles of Good Laboratory Practice (1997)
8. FDA: Immunogenicity Testing of Protein Therapeutic Products-Developing and Validating Assays for Anti-Drug Antibody Detection Guidance for Industry (2019)
9. EMA: Guideline on Immunogenicity Assessment of Therapeutic Proteins (2017)
10. EMA: Guideline on Immunogenicity Assessment of Monoclonal Antibodies Intended for In Vivo Clinical (2012)
11. China Food and Drug Administration (now National Medical Products Administration): Good Laboratory Practice for Nonclinical Laboratory Studies (Order No. 34) (2017)
12. China Food and Drug Administration (now National Medical Products Administration): Guideline for Method Validation of Quantitative Analysis of Biological Samples (2015)
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