HYQURE Capabilities | Biosafety & CMC Testing

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.

HYQURE provides integrated biosafety and CMC testing support for biologics and advanced therapies, including viral clearance/inactivation validation, cell line

Integrated biosafety, molecular, genomic and analytical services for biologics, vaccines, viral vectors and cell & gene therapy programs

Biosafety and QC support for mAbs, recombinant proteins and biosimilars, including viral clearance, cell-line testing, impurities and lot release.

CGT testing for cell banks, viral vectors, replication-competent viruses, microbial safety, genetic stability and release-support workflows.

Virus clearance and inactivation validation for biologics, antibodies, vaccines, gene therapies and other biopharmaceutical manufacturing processes.

Identity, sterility, mycoplasma, adventitious-virus, retrovirus, species-specific virus and tumorigenicity testing for MCB, WCB and related banks.

GMP-level NGS services for viral-vector safety, cell and gene therapy QC, cell-line characterization and broad adventitious-agent detection.

Quality framework for biosafety and CMC testing, including global regulatory alignment, controlled execution, documentation and data integrity.

Supplier-qualification evidence covering CNAS/ISO 17025, ISO 9001, EU QP GMP declarations and biosafety laboratory credentials.

Controlled QMS covering personnel, equipment, materials, methods, environment, deviations, CAPA, change control, audits and management review.

ALCOA+ data controls, LIMS/EMS, electronic signatures, computerized-system validation, audit trails, access control, backup and QA review.

Cell-based adventitious-virus testing with multi-lineage indicator cells, extended culture observation and endpoint HAd/HA assays.

NGS-enabled viral-vector QC for AAV, lentiviral and oncolytic-virus programs, supporting contaminant detection and genetic characterization.

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.