Adeno-Associated Viral Vector Production
Your perfect fit CDMO for AAV vector production
With over a decade worth of viral vector mastery, our team has the experience, knowledge and skill necessary to bring your AAV program from development to patient with precision and speed.
From concept to commercialization, we provide the end-to-end capacity to support your program through every milestone while ensuring the highest standards of quality, safety and regulatory compliance. Equipped with the latest technologies, our state-of-the-art facility is designed with the aseptic manufacture of AAV vectors in mind. With flexibility that drives progress, we deliver consistency and reliability, whatever the batch size.
Research Use Only (RUO) Materials
It’s never “too early” to start working with Genezen. Our support throughout the initial stages of your gene therapy development facilitates a seamless transition to clinical-grade manufacturing. These services encompass the production of research/preclinical-grade adeno-associated viral vectors that meet your research standards and timelines. We can also help you evaluate the best plasmid system, host cell system, and/or transfection conditions for optimal AAV productivity and quality.
Process Development
We deliver a full suite of complementary process development capabilities to support AAV vector production at every stage, including upstream and downstream process improvements. Utilizing a QbD approach, we deliver scalable and manufacturable cGMP processes that are truly commercial-ready. Our platform process for AAV production is serotype agnostic, 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.
- Expression/GOI plasmid design
- Transient transfection
- Producer cell line development
- Design of Experiments (DoE) studies
- Upstream processing
- Downstream processing
- Proof of concept evaluation runs
- Research cell bank production
- Drug Product optimization studies
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. With over 10 years of experience developing AAV platforms and processes, our team has the knowledge required to build robust methods that are QC friendly. All outsourced assays are managed by our team with partnered CROs 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 cGMP vector production expertise highlights the expansive knowledge and technical talent of our team. Ensuring high product throughput and efficiency, our AAV vector production platform utilizes single-use technology and optimized closed and semi-automated processes to deliver larger batches with greater consistency and reliability.
With our available and scalable capacity, we help to ensure a seamless transition from pre-clinical development to commercial manufacturing
- AAV production by transient transfection of adherent or suspension HEK293 cells
- Ability to tech transfer custom AAV production methods as needed
- Ability to compare different production systems to ensure the best process for your product.
Lot Release Testing Services
Lot Release Testing Services
Analytical testing services, including vector stability testing and safety and sterility testing, are also available.
Final Fill / Finish
Final Fill / Finish
As the vital last step for an AAV CDMO program’s preparation for clinical use, our team’s combined expertise allows us to complete the fill / finish process, balancing cost-effective and efficient methods with stringent patient safety measures in accordance with industry best practices and regulatory guidance. Genezen offers fill and finish services in our state-of-the-art facility.
Genezen uses the semi-automated Crystal M1 Filling System from Aseptic Technologies in a bio-safety cabinet housed in a Grade B room. This equipment uses the functionally closed AT-Closed Vial® system, significantly minimizing contamination risks typically associated with manual filling systems. The AT-Closed Vials come fully sterilized and ready to use. Genezen has the capability to fill several vial sizes from 1 mL to 20 mL and can fill as low as 0.1 mL accurately. Once filled, visually inspected, and labeled, these vials can be frozen prior to release and shipping to the clinical site for the therapy administration to the patient.
One or more drug substance (DS) batches can be continuously processed into Drug Product (DP) or frozen at ≤-65C. If more than one DS batch, then the batches are pooled prior to further processing. Compounding or further formulation is performed to meet the target specifications for the DP.
Explore Genezen
Explore Genezen
Lentiviral Vector Production
With unwavering dedication to your program’s success, we deliver high-quality, cost-effective and precise cGMP lentiviral vector manufacturing.
Retroviral Vector Production
We’re your retroviral vector experts. We bring one of the deepest retroviral skill sets in the CDMO space to maintain control over quality and timelines in an increasingly scrutinized landscape and move your program forward with confidence.
Cell Therapy CDMO Services
Leverage our world-class partnerships, streamline your production, and advance your cell therapy to trial and beyond.
