HyQure BioTech

HYQURE is a one-stop biosafety and quality-control CRO supporting biologics, vaccines, and cell and gene therapy products throughout the full development lifecycle—from preclinical studies and IND submissions to clinical development, BLA submissions, and commercial manufacturing. HYQURE operates a biosafety testing centre in Zhejiang, an R&D centre in Shanghai, and a European laboratory in Basel, Switzerland.Our core services include viral clearance and inactivation studies, cell and virus bank characterization, replication-competent virus testing—including RCL, RCR, RCA and rcAAV—commercial lot release testing, microbiological testing, process-residual and HCP/HCD analysis, AAV and lentiviral-vector quality control, and analytical method development, validation and transfer.HYQURE operates under ISO 9001, ISO/IEC 17025–CNAS, GLP/GMP and EU-QP-aligned quality systems, supported by LIMS, EMS and data-integrity controls consistent with 21 CFR Part 11, ALCOA+ and ISPE GAMP 5. With more than 8,000 m² of BSL-2/BSL-2+ facilities and over 170 technical and quality professionals, HYQURE has served more than 400 biopharmaceutical companies and supported over 130 approved submission cases, including more than 60 global approvals. Our China–Europe network provides reliable, traceable and submission-ready biosafety data for FDA, EMA, PMDA, TGA and NMPA/CDE regulatory pathways.