Biologics Safety Testing

Avance Biosciences is a leading provider of biologics safety test, offering Sanger sequencing, qPCR, Southern blot, northern blot and other “Gold Standard” molecular biology and microbiology methods to support our clients’ biologics manufacturing needs.  Our clients benefit from collaboration with a scientific staff who has decades of experience in designing, validating, and executing regulatory submission level testing.  When you partner with Avance Biosciences for your biologics testing needs, we give you undivided attention, share our experience and knowledge, and respond to your needs in a timely manner.

All services are available at either GLP/GMP or research grade.  Click the links in the table below for detailed description of tests offered.  Contact our friendly technical staff to learn more about our biologics testing services and discuss how we can help you.

Service Description
Cell Bank Characterization Avance Biosciences offers a variety of genomic services to test the identity, purity, and genetic stability of the cell banks. Services are offered  at research grade, or under GLP or GMP regulations
Viral Seed Stock Characterization Avance Biosciences offers DNA sequencing, qPCR and other molecular biology tests to evaluate the identity, purity, and titer of viral seeds that used for biologics manufacturing.
Biodistribution study by QPCR Sensitive and target-specific qPCR assays can be custom designed and validated to assess the presence/absence of gene therapy vectors in tissues collected in a preclinical animal safety study.
Residual DNA Testing by qPCR Avance Biosciences offers customized real-time PCR based DNA quantitation services to determine the residual host cell DNA in biological products derived from cell substrates.  Our custom-designed GMP/GLP compliant qPCR method offers a powerful tool to address the safety concerns and satisfy the requirements for regulatory agencies worldwide.
Residual DNA Size Distribution Avance Biosciences offers Southern blot service to determine the size distribution of residual DNA contaminants in various steps of biologics manufacturing processes. DNA extracted from testing samples are separated by Agarose gel electrophoresis and detected by Southern blotting using a 32P labeled probe.
Adventitious Agents Test Avance Biosciences offers a variety of In Vitro assays to detect adventitious virus in cell banks, viral seed stock, raw materials and final products.