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.

Meet HYQURE at CPHI Milan 2026 HYQURE Biotech will join the global pharmaceutical and biopharmaceutical community at CPHI Milan 2026, taking place 6–8 October at Fiera Milano, Italy.

Visit us at Hall 12, Booth 12J45 to discuss how HYQURE can support your biologics and advanced-therapy development programs with integrated biosafety, CMC, molecular, genomic and quality-control testing.

As biopharmaceutical programs become increasingly complex, sponsors need testing partners that can connect technical execution with regulatory expectations, data integrity and development timelines. HYQURE supports programs from preclinical and IND/CTA-enabling development through clinical development, BLA/MAA preparation and commercialization.

Key capabilities available for discussion in Milan Viral Clearance & Inactivation Validation Process-specific virus clearance and inactivation studies for biologics, monoclonal antibodies, recombinant proteins, vaccines and selected advanced-therapy programs, including study design, model-virus selection, method suitability and regulatory-facing reporting. HYQURE has extensive experience supporting viral-safety strategies for international development programs.

Cell Line & Cell Bank Characterization Comprehensive characterization strategies for MCB, WCB, EOPC and other production cell substrates, including identity, sterility, mycoplasma, adventitious agents, retrovirus-related testing and genetic-stability support. HYQURE works with production systems including CHO, HEK293/293, SF9, Vero and other relevant cell substrates.

Cell & Gene Therapy and Viral-Vector Biosafety Support for AAV, lentiviral-vector and cell-therapy programs, including RCL, RCR, RCA and rcAAV testing, cell-bank qualification, adventitious-agent testing, microbial safety, residual nucleic-acid testing and lot-release support.

GMP Lot Release & Stability Testing Quality-control testing supporting later-stage development and commercialization, including microbial safety, residual DNA/RNA/HCP/process-residue testing and release-facing documentation. HYQURE’s broader service portfolio integrates biosafety testing with molecular/genomic and analytical-development capabilities.

NGS, Molecular & Genomic Testing HYQURE provides molecular and genomic capabilities including GMP NGS, viral-contaminant qPCR, rapid mycoplasma NAT, residual DNA/RNA quantification, CGT analytics, AAV and lentiviral-vector QC, and cell-line identity and stability testing.

Quality and regulatory readiness For international sponsors, technical capability alone is not enough. HYQURE operates within a controlled quality framework covering personnel qualification, equipment lifecycle, material control, method validation and verification, deviation and CAPA management, change control, data integrity, audit trails and QA review.

HYQURE’s qualification framework includes CNAS/ISO 17025 accreditation, ISO 9001 certification and EU QP GMP compliance documentation, supporting supplier qualification and audit planning for regulated biosafety and CMC testing programs.

Supporting global biopharmaceutical development HYQURE has served 400+ biopharmaceutical companies and supported 170+ approved IND/BLA cases, including 80+ overseas approved cases. The company operates approximately 8,000 m² of BSL-2 laboratory capacity and supports biologics and CGT programs through integrated biosafety and quality-testing platforms.