Lentiviral Vector Production
Our Lentivirus Production Services Expertise Becomes Your Advantage
We take pride in being your comprehensive partner throughout the entire gene and cell therapy development journey. Whether for dividing or non-dividing cells, lentiviral vectors provide one of the most effective ways of inserting your therapeutic transgene into the host cell genome. As a critical drug substance for your cell therapy, we ensure that every step of the manufacturing process adheres to the highest standards of quality, safety, and regulatory compliance. Starting from plasmid design and cell line development, all the way through process development to manufacturing, we provide support to bring innovative therapies to fruition. Our expertise lies in providing high-quality, cost-effective, and precise lentivirus production services.
Research Use Only (RUO) Materials
We can assist in the initial stages of your gene or cell therapy development and facilitate a seamless transition to clinical-grade manufacturing. Our services encompass the production of research/preclinical-grade lentiviral vector design that can meet your research standards and timelines. We can work with you to evaluate the best plasmid system and/or host cell system for improved raw functional titers.
Process Development
We deliver a full suite of complementary process development capabilities to support preclinical vector production, upstream and downstream process improvements, cGMP scalability assessment and commercial readiness. Our platform process for lentiviral production is reproducible, scalable, manufacturable, 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.
- Expression/GOI plasmid design
- Transient transfection
- Producer cell line development
- Upstream processing
- Downstream processing
- Final product sterile filtration analysis
- Research cell bank production
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 LVV, RVV, and AAV methods available
- Custom method development, optimization, and transfer
- Interim reference material generation
GMP Manufacture
Our expertise in cGMP lentiviral vector production services highlights the expansive knowledge and technical talent of our team.
Ensuring high product throughput and efficiency, our lentiviral 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 (for 4 plasmid transient transfection)
- Proprietary HEK293T suspension (for 4 plasmid transient transfection)
- Next generation HEK293T Packaging (single plasmid transfection)
- Producer cell line
- Cell stacks and fixed-bed bioreactor
- STR bioreactor up to 500L STR and option to increase volume with process intensification
- Proprietary suspension 293T cell line
- Single-use/functionally closed systems for virus harvest, purification and concentration
- Access to cGMP-compliant master cell banks for common cell lines including HEK293T
- Master and working cell bank production
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
Retroviral Vector Production
We can initiate and maintain reliable supply for your early-phase clinical trials and beyond, delivering high-quality, cost-effective, and precise cGMP master cell bank retroviral vector production and host cell expansion via producer cell lines.
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.
