Viral Shedding Assay Services
Viral shedding studies are conducted to evaluate the presence, persistence, and clearance of viral vectors or viral genomes in biological matrices following administration of gene therapy products. In gene and cell therapy development, shedding studies are performed to assess the potential for environmental release, secondary transmission, and replication-competent virus emergence. These studies support regulatory submissions by characterizing vector biodistribution in accessible matrices, duration of detectability, and potential exposure risk.
Samples commonly evaluated include blood, saliva, urine, feces, nasal secretions, and other relevant matrices depending on route of administration and regulatory guidance. Quantitative analysis of viral genomes is performed to define shedding kinetics over time. These data inform assessment of transmission potential, persistence in biological fluids, and unintended distribution to non-target compartments, contributing to dose selection, patient safety evaluation, and regulatory review of gene therapy products.
Viral Shedding Assay Services
Viral shedding studies are conducted to evaluate the presence, persistence, and clearance of viral vectors or viral genomes in biological matrices following administration of gene therapy products. In gene and cell therapy development, shedding studies are performed to assess the potential for environmental release, secondary transmission, and replication-competent virus emergence. These studies support regulatory submissions by characterizing vector biodistribution in accessible matrices, duration of detectability, and potential exposure risk.
Samples commonly evaluated include blood, saliva, urine, feces, nasal secretions, and other relevant matrices depending on route of administration and regulatory guidance. Quantitative analysis of viral genomes is performed to define shedding kinetics over time. These data inform assessment of transmission potential, persistence in biological fluids, and unintended distribution to non-target compartments, contributing to dose selection, patient safety evaluation, and regulatory review of gene therapy products.
Our Expertise
Avance Biosciences supports viral shedding studies for gene therapy programs. We design and execute sensitive molecular assays to detect and quantify viral vector genomes and replication-competent virus in a variety of biological matrices.
Our capabilities include:
- Quantitative PCR (qPCR) and RT-qPCR for viral genome detection
- Droplet digital PCR (ddPCR) for high-sensitivity quantification of low-level shedding
- ELISA for viral antigen or antibody detection where appropriate
- Assay development and validation under GLP and GMP conditions
- Support for replication-competent lentivirus (RCL), replication-competent adenovirus (RCA), or replication-competent retrovirus (RCR) testing as applicable
Our laboratory infrastructure and quality systems support generation of data suitable for inclusion in IND submissions and regulatory filings.
Key Viral Shedding Assays
Assay
Description
qPCR (Quantitative PCR)
Quantifies viral RNA/DNA in a sample using polymerase chain reaction.
RT-PCR (Reverse Transcription PCR)
Detects and quantifies viral RNA using reverse transcription followed by PCR.
ddPCR (Droplet Digital PCR)
High-sensitivity absolute quantification of low-level viral genomes in complex samples.
ELISA (Enzyme-Linked Immunosorbent Assay)
Detects and quantifies viral antigens or antibodies in a sample.