4000
+
Central Lab Testing Menu
600
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Global Clients
3600
+
Clinical Trials
90
+
NMPA Inspections
Bioanalysis
Our experienced team of scientists, familiar with both classic, gold-standard testing as well as the latest advances, are dedicated to meeting our clients' varied bioanalysis needs. KingMylab provides end-to-end solutions to PK, immunogenicity and PD biomarker, testings in the fields of cell and gene therapy, macromolecules, vaccines and more to facilitate the development of these and other therapeutics.
Our extensive expertise in regulatory compliance paired with our long-standing tradition of putting the client’s candidate drug first-offering customized services based on an intricate understanding of drug-specific qualities-ensures that every result and every piece of data can potentially bring your treatment one step closer to approval.
Bioanalysis
The KingMylab Bioanalysis Center in Shanghai provides global bioanalytical services for clinical trials. Our team of experienced scientists and technicians utilize state-of-the-art platforms to develop and perform high-quality bioassays for pharmacokinetics, pharmacodynamics, immunogenicity, biodistribution, and safety and potency analysis to support drug development.
Accelerating clinical development (Phase l to lll clinical trials) by providing accurate, reliable and on-time pharmacological data
Comprehensive methodological validation in accordance with Good Laboratory Practice (GLP), industry White Paper recommendations and FDA/EMA/NMPA guidelines
Expertise in PK, immunogenicity and PD biomarker assays and more. Focused on applying new analytical methods and techniques to deliver optimized and high-impact solutions based on drug and biological matrix intricacies
Support for biological analysis of a wide range of treatment modalities, including but not limited to small and large molecules, antibodies, cellular therapies, RNA therapies, gene-editing therapies, ADCs, PROTACs, and vaccines
Facilities
The center integrates multiple advanced platforms, including LBA (MSD, Luminex, Molecular Devices, Tecan Infinite F), fluorescent quantitative PCR (qPCR), digital PCR (ddPCR), ELIspot (Cytation5, Mabtech), flow cytometry, mass spectrometry, and more, to provide comprehensive chromatography, spectrometry, immunochemistry, molecular, and cell-based analysis.
