Retroviral Vector Production
Reliable And Reproducible Viral Vector Batches
We have leveraged our extensive experience in retroviral vector design and production to establish platform processes that include next-generation fixed-bed bioreactor-based production and TFF concentration steps when required. We utilize single-use technology and optimized closed and semi-automated processes for robust, efficient retroviral vector CDMO services.
By using our established platform, you can be assured that your retroviral production process is both commercializable and scalable and that your RVVs will be manufactured to the highest standards of quality, safety, and regulatory compliance. Our dedication to excellence is evident in our meticulous approach to producer cell line development and master cell bank expansion, both of which ensure consistent and reproducible results.
Research Use Only (RUO) Materials
As your development partner, we collaborate with you all the way from small-scale testing needs, such as evaluation of your GOI/Expression construct, to the design of multi-constructs and production of multi-envelope, research-scale, gamma-retroviral vectors, all aimed at optimizing your initial screening. We provide the flexibility to either leverage our packaging cell lines or adapt to your preferred cell line choices. Our overarching objective is to offer comprehensive support throughout the entire development process.
Process Development
We deliver a full suite of complementary process development capabilities to support research-grade and preclinical vector production with upstream and downstream process improvements geared towards cGMP scalability and commercial readiness. Our platform process for retroviral production is reproducible and designed with commercialization in mind from the start.
We have preferred partnerships with plasmid manufacturers to ensure reliable plasmid supply with short lead times for research-grade and GMP plasmids.
Analytics
Your process is only as good as your analytics. We accelerate your program with in-house analytical assay development and phase-appropriate qualification/validation tailored to your vector and/or gene of interest. Any outsourced assays are managed by our team with special attention to scientific/technical applicability. All OOS and OOT results during testing are carefully evaluated with robust root cause analysis and appropriate CAPAs are applied to ensure that the assays continue to be fit for use.
- Pre-qualified platform for RVV titer analysis
- Custom method development, optimization, and transfer
- Interim reference material generation
GMP Manufacture
Our cGMP retroviral vector production expertise highlights the expansive knowledge and technical talent of our team.
Ensuring high product throughput and efficiency, our retroviral vector production platform utilizes single-use technology and optimized closed and semi-automated processes to deliver larger batches with greater consistency and reliability.
- Adherent HEK293T retroviral transient transfection system
- Ampho- and Eco-Phoenix Packaging cell lines (Single plasmid transfection)
- Producer cell lines – from preclinical to commercial
Lot Release Testing Services
Lot Release Testing Services
Analytical testing services, including vector stability testing and safety and sterility testing, are also available.
Explore Genezen
Explore Genezen
Lentiviral Vector Production
Accelerating your path through development to commercialization, we deliver high-quality, cost-effective and precise cGMP lentiviral vector manufacturing.
AAV Vector Production
With more than a decade’s worth of experience building diverse AAV platforms, processes, and analytics, our team has the knowledge and skill necessary to bring your program from development to patient.
Cell Therapy CDMO Services
Leverage our world-class partnerships, streamline your production, and advance your cell therapy to trial and beyond.
