The Non-GLP Bioanalysis Team has four sites in China. They include our Shanghai, Suzhou, Nanjing, and Nantong sites. All the laboratories have instrument rooms and sample processing rooms. Our team has established a variety of advanced LC-MS platforms to meet customers' analytical needs at different stages. We have a wide range of mass spectrometers, such as multiple generations of Sciex triple quadrupole mass spectrometers, Waters XeVo G2 QToF, Vion QToF, and ThermoFisher Orbitrap Q-Exactive™ Plus, Q-Exactive™ HF, and Eclipse systems. These mass spectrometry systems are coupled with ultrahigh performance liquid chromatography systems such as Waters UPLC and Shimadzu UHPLC. For the screening stage in vitro sample bioanalysis, high throughput autosamplers such as CTC and ADDA are utilized. SpectraMax M5/M5e instruments from Molecular Devices and QuickPlex SQ120 instrument from MSD are applied for the LBA analysis of large molecules. In addition, we have multiple automated sample preparation systems such as the HP D300e instrument and Hamilton Microlab STAR™ liquid handler workstation to support fast sample preparation.
Non-GLP bioanalytical instrument room
Sample preparation laboratory equipped with yellow light lamps to avoid photodegradation of the compounds
Selected high-performance liquid chromatography systems of Non-GLP bioanalysis laboratory
Selected high throughput autosampler systems of Non-GLP bioanalysis laboratory
Selected triple-quad mass spectrometry systems of Non-GLP bioanalysis laboratory
Selected high-resolution mass spectrometry systems of Non-GLP bioanalysis laboratory
Selected ligand binding assay instrument platforms of Non-GLP bioanalysis laboratory
Selected automation systems of Non-GLP bioanalysis laboratory
References
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)
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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