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Bioanalytical Services

Bioanalytical Services:

1. Small molecule Bioanalysis

Xihua has 27 sets of UPLC-MS-MS system, one ICP-MS and one High resolution MS, include 11 set of AB Sciex 6500+. Xihua has already developed and validated more than 200 generic drug analytical methods, include inhalation drug, insulin, ADC, unstable drug, liposome and endogenous drugs etc. Among domestic labs, Xihua leads on top in completion of consistency evaluation of generic drugs. For the first in human (FIH) and other urgent studies, a fast turn around can be provided and secured. Xihua has established collaboration with other 100 domestic clients and 3 international clients. Xihua also provide services in PK calculation and BE equivalence statistics.

2. Large molecule Bioanalysis

Provide services for method development, validation and sample analysis for Biosimilar, Bispecific antibody, ADC, Pegylated peptide and fusion protein, etc, with respect to PK, ADA, Nab and Biomarker bioanalysis; Support more than 50 clinical trials of novel drugs and biosimilars. Outstanding cell-based Nab capabilities, with fully validated cell based Nab assays for Panituzumab, Bevacizumab, Romiplostim, TPO, FSH and Exenatide, etc. Multiple PD methods have been validated for diabetes (including insulin, C-peptide, DPPIV activity assay, HBA1c), inflammation, oncology and bone metabolism. With approximately 40 experienced personnel, and diversified detection platforms, including Molecule Device Plate Reader, MSD SQ120,BD LSR FACS, AB QuantStudio 12 k Flex QPCR, Tosch G8 HBA1c, Protein Simple Ella, etc.

Bioanalytical Services