New Pillar Page: Cell & Gene Therapy Bioanalytical Services
- No Comments
Accelerating AAV, Lentiviral, and mRNA Programs from Discovery to the Clinic.
Developing cell and gene therapies requires more than standard lab services; it demands a bioanalytical partner who understands the unique behavior of viral vectors and engineered cells in vivo. Accelevir provides a comprehensive suite of molecular and immunology assays designed to characterize your product, track its distribution, and monitor patient safety.
We support a wide range of modalities, including In Vivo CAR-T, Ex Vivo Engineered Cells, Gene Editing (CRISPR/Base), and RNA Therapeutics.
Our Core Capabilities
Biodistribution & Shedding (GLP/Non-GLP)
Confirming where your vector goes—and where it stays—is a critical safety requirement. We utilize ultra-sensitive dPCR (digital PCR) and qPCR platforms to detect and quantify vector genomes in a wide array of biological matrices.
- Tissue tropism mapping.
- Clearance and shedding analysis (blood, urine, saliva).
- Germline transmission studies.
Drug Product Characterization
Ensure your therapeutic meets rigorous quality standards before it reaches the patient.
- Vector Copy Number (VCN): Precise determination of average copy number per cell using dPCR.
- Viral Vector Titration: Accurate physical and infectious titer measurement for AAV, Lentivirus, and other vectors.
- Transgene Expression: Quantifying the expression levels of your payload in target tissues.
Immunogenicity & Safety Monitoring
The immune response to viral vectors or transgenes can compromise efficacy and safety. We offer a tiered approach to immunogenicity testing:
- ADA & Anti-Capsid Antibodies: Screening and confirmatory assays for antibodies against the vector or payload.
- Neutralizing Antibody (nAb) Assays: Cell-based and ligand-binding assays to assess neutralization.
- Cytokine Release Syndrome (CRS): Multiplex profiling (Luminex/MSD) to monitor inflammatory cytokines.
Partner with Accelevir
Don’t let bioanalytical challenges delay your IND. Partner with a CRO that specializes in the complexities of cell and gene therapy.