Our clinical bioanalytical team is equipped with a wide range of state-of-the-art small and large molecule related instruments and equipment, as well as a team of experienced experts and technicians, and has implemented a highly efficient and agile information-based project management system. The InnoStar’s Bioanalytics team adheres to the highest global quality standards and provides comprehensive and professional one-stop services in compliance with NMPA/FDA/OECD/EMA/ICH regulations. Our services cover pharmacokinetics, pharmacodynamics, anti-drug antibodies, neutralizing antibodies, cellular immunity, biomarkers, viral shedding, viral activity assays, etc. Our services cover a wide range of drugs, including small molecules, macromolecules, cellular and gene therapies, vaccines, neoantigens and other novel drugs, and support the full life cycle of bioanalytics, including drug discovery, preclinical studies, clinical studies, and post-market drug monitoring.
InnoStar provides comprehensive, professional one-stop solutions to support bioanalysis during the full lifecycle from discovery, preclinical studies and clinical trials, to post-marketing drug monitoring.
【Internationalized Compliance System and Laboratory】Dual China-U.S. labs with PL+PM+PI digital management to expedite global drug R&D.
【Multi-Technology Platform Coverage】PCR/ddPCR, spectral flow, NGS for complex analysis of gene/cell therapies and nucleic acid drugs.
【Methodology innovation】Dual/multi ADA assays, Nab strategies, 40+ validated assays (cytokine/TGF-β) to resolve target interference and shorten cycles.
【Rich industry experience】200+ projects in ADC/CAR-T/mRNA vaccines/PROTACs, standardized AAV/nucleic acid metabolism workflows, supporting China-U.S. approvals via PK/immunogenicity/biomarker platforms (flow/MSD/Luminex) for full drug lifecycle solutions.
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