6
Oct
2026
HYQURE Biotech
About HYQURE Biotech
Certifications
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FDA -
GMP -
ISO
Categories
Meet us at
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CPHI Milan 2026
Fiera Milano, Italy
6 Oct 2026 - 8 Oct 2026stand 12J45
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Country/Region:Switzerland
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Founded:2020
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On CPHI since:2025
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Certificates:4
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Employees:100 - 249
Company types
Primary activities
Products from HYQURE Biotech (5)
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Product Cell Line & Cell Bank Characterization
HYQURE provides cell line and cell bank characterization for production substrates used in biologics, recombinant proteins, antibodies and cell-therapy products. Programs can be configured for Master Cell Banks (MCB), Working Cell Banks (WCB), Research Cell Banks (RCB), EOPC and related cell substrates, wi... -
Product CGT & Viral Vector Biosafety Testing
HYQURE supports cell & gene therapy and viral-vector programs with integrated biosafety, vector characterization and replication-competent virus testing. Supported pathways include RCL, RCR, RCA and rcAAV testing, AAV- and lentiviral-vector QC, cell-bank characterization, adventitious-agent control, microb... -
Product GMP NGS & Molecular Testing
HYQURE provides GMP-level next-generation sequencing (NGS) and molecular testing across biopharmaceutical R&D and quality control, with end-to-end support from sample preparation through sequencing, bioinformatics and data interpretation. Applications include cell banks, viral vectors, batch-harvest materi... -
Product HyPrecise® Biosafety & QC Detection Kits
HyPrecise® is HYQURE Biotech’s testing-product brand for biopharmaceutical quality control and biosafety applications. The portfolio includes Host Cell Residual DNA Detection Kits, Microbial Detection Kits, Safety Detection Kits and Host Cell Residual Protein Detection Kits, supporting biologics, vaccines,... -
Product Viral Clearance & Inactivation Validation
HYQURE provides regulatory-focused viral clearance and viral inactivation validation for biologics, monoclonal antibodies, recombinant proteins, vaccines, blood-derived products and selected advanced-therapy workflows. Study design is tailored to the product, manufacturing process, development stage and ta...
HYQURE Biotech Resources (16)
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News Meet HYQURE at CPHI Milan 2026: Biosafety & CMC Testing for Biologics and CGT
HYQURE Biotech will exhibit at CPHI Milan 2026, 6–8 October at Fiera Milano. Visit Hall 12, Booth 12J45 to discuss viral clearance, cell-bank characterization, replication-competent virus testing, GMP QC, NGS and regulatory-ready biosafety strategies for biologics, viral vectors, vaccines and cell & gene therapies. -
Brochure One-Stop Biosafety & CMC Testing Services
HYQURE provides integrated biosafety and CMC testing support for biologics and advanced therapies, including viral clearance/inactivation validation, cell line -
Brochure HyQure Services page
Integrated biosafety, molecular, genomic and analytical services for biologics, vaccines, viral vectors and cell & gene therapy programs -
Brochure Biologics Testing & Characterization
Biosafety and QC support for mAbs, recombinant proteins and biosimilars, including viral clearance, cell-line testing, impurities and lot release. -
Brochure Cell & Gene Therapy Biosafety & CMC
CGT testing for cell banks, viral vectors, replication-competent viruses, microbial safety, genetic stability and release-support workflows. -
Brochure Viral Clearance Studies
Virus clearance and inactivation validation for biologics, antibodies, vaccines, gene therapies and other biopharmaceutical manufacturing processes. -
Brochure Cell Line & Cell Bank Characterization
Identity, sterility, mycoplasma, adventitious-virus, retrovirus, species-specific virus and tumorigenicity testing for MCB, WCB and related banks. -
Brochure GMP NGS Services
GMP-level NGS services for viral-vector safety, cell and gene therapy QC, cell-line characterization and broad adventitious-agent detection. -
Brochure Quality & Compliance
Quality framework for biosafety and CMC testing, including global regulatory alignment, controlled execution, documentation and data integrity. -
Brochure Certifications & Accreditations
Supplier-qualification evidence covering CNAS/ISO 17025, ISO 9001, EU QP GMP declarations and biosafety laboratory credentials. -
Brochure Quality Management System (QMS)
Controlled QMS covering personnel, equipment, materials, methods, environment, deviations, CAPA, change control, audits and management review. -
Brochure Data Integrity & Digital Systems
ALCOA+ data controls, LIMS/EMS, electronic signatures, computerized-system validation, audit trails, access control, backup and QA review. -
Brochure In Vitro Adventitious Virus Testing
Cell-based adventitious-virus testing with multi-lineage indicator cells, extended culture observation and endpoint HAd/HA assays. -
Brochure AAV & Lentiviral Vector QC
NGS-enabled viral-vector QC for AAV, lentiviral and oncolytic-virus programs, supporting contaminant detection and genetic characterization. -
Video HYQURE Capabilities | Biosafety & CMC Testing
Discover HYQURE’s integrated biosafety, viral safety, CGT, molecular and GMP QC capabilities supporting biologics and advanced therapies from development through commercialization.
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Video About HYQURE
HYQURE focuses on biosafety testing specializing in Biologics and cell/gene therapy. As a trusted, global-compliant partner to 300+ recognized biotechs/biopharmas, we have had more than 110 successfully approved IND or BLA cases and more than 50 of them have been approved by FDA, EMA, TGA etc. The capability of methodologies and quality systems we’ve built have been recognized by global regulatory authorities.