Bioanalysis & Detection
Service Overview
Specialized in the qualitative and quantitative analysis of biologic molecules and small molecules, covering proteins, antibodies, peptides, ADCs, oligonucleotides, chemical drugs, and their metabolites，we provide complete solutions from analytical method development and validation to sample testing, offering precise and reliable mass spectrometry support for drug R&D and life science research.
Preclinical Bioanalysis
(1)Method development and validation.
(2) Quantitative analysis of biological samples for PK/PD and tissue distribution studies (small molecules, traditional Chinese medicine, peptides, oligonucleotides, metabolites, etc.).
Clinical Bioanalysis
(1) Bioequivalence trial and Phase I clinical trial sample testing.
(2) Clinical pharmacy services, such as therapeutic drug monitoring (TDM) for steroid hormones, antiepileptics, catecholamines, vitamins, etc.
Quality Research
Analysis of active ingredients and trace elements in raw materials, excipients, intermediates, and formulations.
Mass Spectrometry Characterization
(1) Protein/Peptide Structural Characterization: Intact protein molecular weight determination, peptide coverage mapping, N-terminal/C-terminal sequence analysis, post-translational modification identification, disulfide bond mapping.
(2) Antibody Drug Characterization: Intact antibody, deglycosylated, light chain, heavy chain molecular weight determination, peptide mapping, glycan profiling & glycosylation site identification, Antibody-Drug Conjugate (ADC) Drug-to-Antibody Ratio (DAR) determination, conjugation site identification.
(3) Nucleic Acid Analysis: Oligonucleotide molecular weight determination, modified nucleotide identification, impurity analysis.
(4) Small Molecule & Traditional Chinese Medicine Component Analysis.
Drug Metabolism Studies
(1)In vitro metabolic stability studies (metabolite identification after incubation in plasma, whole blood, liver microsomes/hepatocytes, S9).
(2)In vivo metabolite analysis (metabolite identification in plasma, urine, feces, and other biological samples).
(3) Metabolic pathway elucidation (structural confirmation of Phase I/II metabolites).
