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HyQure BioTech

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Giới Thiệu Công Ty

  • Tên pháp lý: HyQure BioTech
  • Quốc gia đăng ký: China
  • Địa chỉ: China Mainland Shanghai Building 18, Lane 2777 East Jinxiu Road, Pudong New Area, Shanghai, China
Mô tả:

HYQURE Biotech, founded in 2020 in Zhejiang, is a one-stop biosafety and quality-control CRO supporting biologics, vaccines, and cell and gene therapy products across their full development lifecycle -- from preclinical studies and IND submissions through BLA filing and commercial manufacturing -- via viral clearance, cell and virus bank characterization, replication-competent virus testing, commercial lot release, microbiology, and HCP/HCD analysis. The company operates biosafety testing facilities in Zhejiang exceeding 8,000 square meters, an R&D center in Shanghai, and -- since 2025 -- a European laboratory in Basel, Switzerland, forming an integrated China-Europe service network with experience supporting FDA, EMA, PMDA, TGA, and NMPA/CDE submissions under quality systems aligned to 21 CFR Part 11, ALCOA+, and ISPE GAMP 5. Backed by a USD 30 million Series B round completed in 2024 and proprietary IP covering replication-competent virus detection and related testing methods, HYQURE now serves more than 400 biopharmaceutical companies with over 130 approved cases including 60-plus global approvals, offering CRO services to markets across North America, Western and Eastern Europe, Australasia, Asia, Central/South America, the Middle East, and Africa.

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Chứng nhận

Chứng Nhận ISO 9001

GMP and EU-QP-aligned quality systems

FDA

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