Biosafety & CMC Testing by Modality | HyQure

Specialized Biosafety and CMC Testing Across Therapeutic Modalities

Route biologics and advanced-therapy programs into phase-appropriate biosafety, viral safety, cell line, release, and QC support pathways.

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MODALITY

Comprehensive Biosafety and CMC Support for Complex Modalities

HyQure supports biologics and advanced-therapy programs with biosafety, viral safety, cell line characterization, replication-competent virus control, microbial testing, process residue control, lot release support, and quality-controlled reporting. This modality hub helps sponsors move quickly into the right pathway and then into the connected services, quality pages, and next-step actions.

Select Your Modality Pathway

Cell & Gene Therapy

CGT Overview

CAR-T & CAR-NK CMC

In Vivo CAR Safety

iPSC Cell Bank (GMP)
Biologics & Complex Proteins

Biologics Overview

ADC Characterization

Vaccine Development

Oncolytic Virus Safety

RNA & LNP Analytics

Core Modality Testing Capabilities

Viral Clearance and Viral Inactivation Validation

Study design and execution for process-specific viral clearance or inactivation steps relevant to biologics, vaccines, and selected advanced-therapy workflows.
Cell Line and Cell Bank Characterization

Identity, sterility, mycoplasma, adventitious-agent, retrovirus-related, and genetic-stability testing for production cell lines and cell banks.
RCV and AAV-Related Biosafety Testing

RCL, RCR, RCA, and rcAAV pathways, together with AAV characterization elements such as rcAAV and TCID50 where relevant to the program.
Lot Release, Process Residue, and QC Support

Lot release testing, microbial safety, host-cell residual DNA, HCP or HCD-related support, and QC kits aligned to product stage and testing scope.

Why HyQure - Advantages

Built for biosafety-critical programs

HyQure supports biologics, vaccines, and advanced therapies with testing pathways designed around viral safety, cell line qualification, microbial control, release support, and sponsor-facing documentation.
One-stop service scope

Supported service areas include viral clearance and viral inactivation validation, cell line characterization, RCV testing, lot release testing, virus bank testing, iPSC or MSC characterization, process residue testing, and impurity-detection kits.
Controlled quality and data environment

Quality systems, data-integrity controls, computerized systems, and documented reporting frameworks strengthen the reliability of study outputs and sponsor review packages.
Project & logistics coordination

Sample-information forms, customs coordination, cold-chain transportation, temperature traceability, and project-management workflows help reduce avoidable operational delays.

Why HyQure-Service Fit

Use Cell & Gene Therapy (CGT)

For cell and gene therapy programs requiring biosafety, cell-bank qualification, vector-risk control, microbial testing, and release-support documentation across development and manufacturing stages.
CAR-T and CAR-NK CMC Testing

For engineered lymphocyte programs requiring RCL/RCR risk control, cell-substrate and bank testing, microbial safety, process-residue support, and release-facing CMC documentation.
In Vivo CAR Safety Testing

For in vivo programming strategies requiring vector-biosafety assessment, replication-competent virus pathways, contaminant testing, residual nucleic-acid support, and matrix-specific biosafety investigations.
iPSC Cell Bank Testing (GMP)

For iPSC, MSC, and related cell-substrate programs requiring identity, genetic-stability, adventitious-agent, microbial, and cell-bank qualification support for regulatory-facing documentation.
Biologics

For monoclonal antibodies, recombinant proteins, biosimilars, bispecific or trispecific antibodies, and related biologics requiring viral clearance, cell-line characterization, impurity control, microbial testing, and release support.
ADC Characterization Testing

For ADC-associated biologics programs requiring biosafety, viral clearance, production cell-line qualification, host-cell impurity support, microbial control, and release-oriented quality documentation.
Vaccine Development

For vaccine programs requiring seed-lot or virus-bank support, adventitious-agent testing, microbial control, viral safety assessment, and release-support documentation.
Oncolytic Virus Safety

For oncolytic-virus and related viral-therapeutic programs requiring adventitious-agent control, genetic-stability support, microbial testing, virus-testing pathways, and quality-focused release documentation.
RNA and LNP Analytics

For RNA and LNP programs requiring raw-material biosafety, residual nucleic-acid control, microbial testing, process-residue support, and QC-focused analytical documentation within HyQure's confirmed service scope.