Analytical Development and Testing Services
Extended RCL and RCR Testing
We have the capacity to deliver both extended and qPCR-based replication-competent lentivirus (RCL) assays. Our vast lentiviral vector design expertise means we can provide reliable and efficient testing to accelerate your therapy to the clinic and beyond. We are also able to complete RCR testing upon request.
Unique In-House Viral Vector Services Capacity and Experience
Genezen is committed to collaborating with your team throughout every step of the process. We leverage our extensive experience to offer both platform and custom analytical tests specifically designed to suit the unique requirements of your viral vector or cell therapy. Developing robust and reproducible analytical methods, along with establishing reference standards during preclinical development, becomes instrumental in expediting your process development. Genezen’s approach is geared towards not only meeting regulatory standards but also facilitating a streamlined pathway for the approval and launch of gene and cell therapy products.
- Biological titers
- Vector genome titers
- Physical titers (p24 and AAV capsid by ELISA)
- Empty vs Full particle ratio
- Transduction efficiency
- TCID50
- Vector Copy Number by ddPCR
- Vector insert identity & stability
- Genome Integrity by NGS
- Insertional site analysis
- Producer Cell line Stability testing
- Viral vector Stability testing
- Transgene length and Stability
- Residual Benzonase
- Host cell proteins
- Host cell DNA
- Plasmid DNA
- E1A qPCR*
- SV40 qPCR*
- Other Residual Process impurities*
*Off-site services managed by the Genezen team
Explore Genezen
Explore Genezen
With unique expertise in cGMP lentiviral, retroviral, and AAV vector manufacturing, paired with a new state-of-the-art facility, we have the capacity and know-how to support your viral vector manufacturing needs.
Leverage our world-class partnerships, streamline your production, and advance your cell therapy to trial and beyond.
