Facilities
Our viral vector facility has the capacity and technologies to accelerate your cell and gene therapy development and manufacturing. We are continually investing in our facilities to ensure flexibility and minimize time to trial and beyond for our customers.
STATE-OF-THE-ART FACILITY
Indianapolis, Indiana
We manufacture your viral vectors using validated processes in our FDA-compliant facility, specifically designed to expedite your gene therapy development.
Design
- New state-of-the-art cGMP-compliant multi-vector production facility (first 25,000 square foot phase in a multiphase plan for a 75,000+ square foot facility)
- cGMP-compliant cleanroom suites at ISO 7 and ISO 8
- Suspension viral vector production: Up to 200L
- Adherent viral vector production: Up to 70L/500m2
- Full suite of process development and analytical capabilities
- cGMP suites specifically designed for maximum productivity and efficient production
Accessibility
- Midwest location with logistics hub resources
Full Spectrum of Capabilities
From the site, we deliver a full spectrum of complementary viral vector process development capabilities to support cGMP and commercial readiness, upstream and downstream process improvements, research-grade and preclinical vector production, and analytical assay testing and validation.
Recombinant Competent Lentivirus (RCL) testing (extended and qPCR), vector stability testing, and safety and sterility testing are available.
Equipment Highlights
Our expert team leverages powerful and state of the art technologies to accelerate your cell and gene therapy so you can meet the standards of today and prepare for the future. With deep expertise in early phase development and manufacturing, we can provide you with cost-appropriate services, making viral vector production accessible.
Processing
- Xpansion Bioreactor System (Seed train)
- iCELLis 500 Bioreactor System
- Mixers – 200L-500L
- AKTA readyflux TFF system
- AKTA ready chromatography system
Cell Expansion
- Seed train Suspension cells (WAVE Bioreactor)
- Incubator – 150L
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Academic Partnerships
Research Institution Partners
Genezen has established partnerships with the labs at Indiana University and Cincinnati Children’s Hospital Medical Center.
Genezen provides exceptional customer service and contracting to facilitate access to academic core resources and talent. Together with our in-house capabilities, they expand the contract laboratory and storage facility services we provide.
Cincinnati Children’s Hospital Medical Center Translational Core Laboratory
We can transduce the following cell type:
- Hematopoietic progenitors and stem cells
- T lymphocytes and other immune cells
- Embryonic and induced pluripotent stem cells
We offer more-than-minimally manipulated cell and tissue procedures performed aseptically in the cleanroom in accordance with GMP / GTP quality compliance requirements. Our cell manufacturing services encompass:
- Enrichment or depletion of specific cell subsets
- Genetic modification (transduction)
- Expansion, differentiation
- Product cryopreservation
- Cellular stability studies
- Thaw and preparation for infusion
Indiana University
Our partnership with Indiana University and its Gene Therapy Testing Laboratory increases our capacity for high-quality clinical trial subject sample testing and release testing services, including:
- Biologic Replication Competent Virus
- RCL (Lentivirus)
- RCR (Retrovirus)
- PCR Testing
- VSV-G, GALV, and RD114 envelopes
- Adenoviral E1a and SV40 virus T antigen
- Insertion Site Analysis
- PERT Assay
- p24 ELISA
