Cutting edge strategies for emerging gene therapy modalities
Celerion’s expertise across a range of therapeutic types:
- Wild-type and modified adenovirus (AdV), adeno-associated virus (AAV), and lentivirus (LV) vectors
- Encapsulated and naked plasmids and mRNAs
- siRNA, RNA and DNA and Oligos
Full-service gene therapy services
Celerion offers a full suite of bioanalytical assays for gene therapies, allowing our clients to simplify their outsourcing with a single, top-tier CRO partner:
- Vector Shedding – Safety
- Biodistribution – Vector and/or Transgene
- Transgene Expression – mRNA, therapeutic protein product
- Humoral Immunogenicity – Enrollment (CLIA) or Safety (GxP)
- Total Antibody or Anti-Drug Antibody – Vector, Transgene
- Neutralizing Antibody – Vector, Transgene
- Cellular Immunogenicity – Vector and Transgene
- Biomarker Assays – cytokine panels, custom protein or RNA quantitation
Rapid solutions for common gene therapy challenges
Building bioanalytical assays for gene therapy products means proactively addressing many common pitfalls including sourcing and handling of critical reagents such as vector capsids, applying appropriate statistical approaches for pre-existing antibody titers, and designing robust methods across a range of tissue sample types. See examples of some of our thoughtful, scientifically robust approaches: