CGT Biosafety & CMC Testing | HyQure

Cell and Gene Therapy Biosafety and CMC Testing

Biosafety, vector, cell-bank, microbial, RCV, and release-support pathways for cell and gene therapy programs.

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Cell & Gene Therapy (CGT) Solutions

Cell and gene therapy programs require targeted control of viral-vector risk, cell-substrate quality, microbial safety, process residues, and release-facing documentation. HyQure supports ex-vivo and in-vivo CGT workflows with cell bank characterization, RCV pathways, viral clearance or inactivation validation where relevant, AAV-related biosafety testing, microbial testing, and lot-release support.

Why HyQure - Advantages

CGT-relevant vector and cell-bank support

Supported pathways include cell line and cell bank characterization, RCL/RCR/RCA/rcAAV testing, in-vitro and in-vivo virus testing, and AAV-related biosafety elements where relevant to the product.
Residual impurity and QC support

Host-cell residual DNA, HCP or HCD-related support, process-residue testing, and QC kits can be incorporated where applicable to program stage and manufacturing strategy.
Microbial and controlled release support

Microbial testing, mycoplasma pathways, endotoxin support, and later-stage lot-release workflows help protect timelines without relying on unrealistic speed claims.
Regulatory-aware reporting

Reports are best described as phase-appropriate, audit-ready, and structured for sponsor quality documentation and regulatory-facing review.

Coverage of Treatment Types

CAR-T / CAR-NK / TCR-T / TIL

ex-vivo engineered lymphocyte products that require vector-related biosafety control, microbial safety testing, and release support.
iPSC / MSC and related cell products

Cell-substrate programs that require identity, genetic-stability, adventitious-agent, and microbial testing strategies.
AAV and gene-therapy programs

Vector and gene-delivery programs that may require RCV pathways, AAV characterization elements, and viral safety documentation.
Phase-based support

Preclinical, IND-enabling, clinical, BLA-associated, and commercialization-related testing can be described using phase-appropriate wording.

Core Service Capabilities

Cell bank characterization

MCB, WCB, EOPC, and related cell-bank testing strategies covering identity, sterility, mycoplasma, genetic stability, adventitious agents, and retrovirus-related methods where relevant.
Replication-competent virus pathways

RCL, RCR, RCA, and rcAAV pathways with method suitability, validation support, and controlled reporting for relevant matrices.
Viral clearance / inactivation validation

Process-risk assessment, multi-indicator study design, and step-specific evaluation for viral clearance or inactivation where the process requires it.
Product biosafety, microbial, and release support

Microbial testing, in vitro or in vivo virus testing, process-residue support, AAV-related biosafety elements, and lot-release workflows for later-stage programs.