Applications

Gene Therapy - Viral Vector

Virotherapy/Oncolytic Virus:

Clients have long appreciated Viracor’s expertise in anti-viral and vaccine development.  In fact, our combined experience with viral vectors and de novo assay development was instrumental to our role in the development of the first FDA-approved oncolytic virus immunotherapy for the treatment of cancer (melanoma) in 2015.

We offer a broad portfolio of clinically relevant testing services to aid in viral vector-based gene therapy development:

• Cell-based assays for immune function and proliferation
• Transgene or target protein expression
• Detection and quantification of the viral genome in serum (or target tissue)
• qPCR and ddPCR for replication-competent lentivirus (RCL) and replication-competent retrovirus (RCR) testing, and measuring gene persistence
• Quantitative analysis of biodistribution/viral shedding by qPCR for both primary and secondary outcomes measures, as well as safety testing to assess potential for transmission
• Assays for measuring anti-drug antibodies (ADA) against the oncolytic virus
• Neutralizing Antibody (NAb) assays to detect neutralizing activity against the vector

Click here to view our case study: Validation and Transfer of Biodistribution and Viral Shedding Assays in Development of an Oncolytic Virus Immunotherapy Candidate.