About Us
HyQure Biotech relies on international compliance standards, leverages excellent quality and
technical strength, and has built a one-stop
Biosafety service platform focusing on large molecule drugs and CGT drugs. It has passed the EU
QP, CNAS, and ISO9001 audit certifications,
meeting the strict requirements of global regulatory agencies such as NMPA, FDA, and EMA,
providing reliable assurance for innovative
pharmaceutical companies. HyQure Biotech has served 400+ biopharmaceutical companies, with rich
experience in project and application, and has
helped 170+ approved cases, including 80+ global approved cases and 60+ BLA and
Commercialization Projects, to obtain clinical and market trial
approvals.
Our services include virus clearance validation, cell bank identification, commercial batch
release, replication-competent virus (RCL, rcAAV,
RCR, etc.) testing, testing services for HCD and HCP kits.
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170+IND or BLA Approved Cases
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80+Global Approved Cases
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400+Biopharmaceutical clients
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500+Collaborated Pipelines
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8000+㎡BSL2/BSL-2+ Laboratory
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13+Successful Licensed Out Cases
Technologies
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Viral Clearance Studies,Retrovirus Testing,In Vitro Adventitious Virus (IVA),In Vivo Adventitious Agents,RCL/RCR/rcAAV Testing
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Cell Line Characterization,Cell Line Identity & Stability,AAV & Lentiviral Vector QC,CGT Analytical Services
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NGS & Precision Molecular Detection
Viral Contaminant qPCR Panels,Rapid Mycoplasma (PCR/NAT),Residual DNA/RNA Quantification,GMP NGS Services
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Cutting-Edge Analytical Development
Custom Assay Development,Method Validation (ICH Q2),Method Transfer & Lifecycle,Physicochemical Analysis
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mRNA/LNP Analytics & QC,Emerging Modalities (mRNA, Exosomes, etc.)
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Integrated GMP Quality Solutions
Lot Release & Stability (GMP),Mycoplasma & Sterility (GMP),Raw Material QC Testing,Vaccine Safety & Potency
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CAR-T & NK CMC Testing
Ex vivo CAR-T and CAR-NK programs require rigorous donor material screening and cell-bank characterisation.
In Vivo CAR Safety Testing
In-vivo CAR therapies use adeno-associated or other viral vectors to deliver genetic cargo directly to patients.
iPSC Cell Bank Testing (GMP)
iPSC-derived products offer off-the-shelf regenerative solutions but come with stringent requirements for cell substrate characterisation and genetic stability.
ADC Characterization Testing
Antibody–drug conjugates (ADCs) and other conjugated therapies combine biologics with potent small-molecule payloads, adding complexity to biosafety testing.
Vaccine Development Testing
Vaccine developers must demonstrate the absence of adventitious agents, quantify potency, and ensure sterility of each batch.
Oncolytic Virus Safety Testing
ncolytic viruses and other viral therapeutics require proof of genetic stability and absence of replication-competent contaminants.
RNA & LNP Analytical Development
RNA and lipid nanoparticle (LNP) therapies bring novel safety considerations: raw materials must be free from viral and microbial contaminants, and residual process materials must be quantified.
