Facilities & Partnerships
We are continually investing in our facilities and fostering collaborative relationships with key laboratory and research institutions to ensure flexibility and minimize time to clinical trials and to commercial launch.
Indianapolis Development & Manufacturing Facility
We produce viral vectors using meticulously validated processes within our state-of-the-art FDA-compliant facility in Fishers, IN, just outside of Indianapolis, which has been purposefully designed to accelerate and streamline the gene therapy development process with integrated, on-site testing alongside cGMP manufacturing, ensuring efficiency and adherence to the highest quality standards. With a firm commitment to safety and quality, we employ cutting-edge technologies and adhere to rigorous protocols to guarantee consistent and reliable viral vector manufacturing capacity.
- New 60,000 ft2 state-of-the-art cGMP-compliant multi-vector production facility
- cGMP-compliant cleanroom suites at Grade B and Grade C
- Suspension viral vector production
- Adherent viral vector production
- Full suite of process development and on-site analytical capabilities
- cGMP suites specifically designed for maximum productivity and efficient production
Lexington, MA Commercial Gene Therapy Manufacturing Facility
Genezen’s Lexington, MA facility expands our gene therapy manufacturing capabilities with cutting-edge technology and extensive operational space. This 86,000 ft2 classified manufacturing spacestate-of-the-art facility supports commercial-scale viral vector production, ensuring efficiency, safety, and adherence to rigorous cGMP standards. Strategically located in the greater Boston biotech hub, this facility is poised to accelerate gene therapy development and manufacturing with its advanced infrastructure and robust quality control systems.
- 86,000 ft2 state-of-the-art, licensed viral vector manufacturing
- 20,000 ft2 development and QC support labs
- 12,000 ft2 classified manufacturing space
- Two upstream and downstream drug substance process trains
- One dedicated to 8 x 25L rocking bioreactors
- One flexible suite for 8 x 25L rocking bioreactors or 1 x 500L stirred tank bioreactor
- Adherent and suspension bioreactors supported
- Ability to expand to 1000 L or 2000 L
Full Spectrum of Capabilities
Full Spectrum of Capabilities
Genezen delivers 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 in-house.
Equipment Highlights
Our expert team leverages powerful state of the art equipment to accelerate your gene or cell therapy so you can meet the standards of today and prepare for the future. With deep expertise in all phases of development and manufacturing, we can provide you with cost-appropriate services, making viral vector production accessible.
- Xpansion Bioreactor System (Seed train)
- iCELLis 500 Bioreactor System
- Mixers – 200L-500L
- AKTA-ready flux TFF system
- AKTA-ready chromatography system
- cGMP equipment
- Bioquell Qube isolators
- Fixed bed bioreactors
- iCELLis™ 500
- Univercells Scale-X™
- Cytiva XDR 50L & 500L STRs
- AKTA gradient / AKTA ready chromatography skids
- AKTA ready Flux and Repligen KR2i TFF skids
- Automated single-use RoSS Fill CGT (10-250mL bags)
- Crystal M1 Filler (Aseptic Technologies: 1-20mL vials)
- Rees EMS
Research Institution Partners
Genezen has established partnerships with Indiana University and Cincinnati Children’s Hospital Medical Center.
Genezen provides exceptional customer service and efficient contracting to facilitate access to academic core resources and talent. Coupled with our in-house capabilities, our research partners expand the contract laboratory services we provide.
Cincinnati Children’s Hospital Medical Center Translational Core Laboratory
Cincinnati Children’s Hospital Medical Center Translational Core Laboratory
The CCHMC has extensive experience transducing the following cell types:
- 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
Indiana University
Our partnership with the renowned Indiana University Gene Therapy Testing Laboratory increases our capacity and allows us to provide best-in-class clinical trial subject testing as well as release testing services for our clients, including:
- Biologic Replication Competent Virus
- RCL (Lentivirus)
- RCR (Retrovirus)
- PCR Testing
- VSV-G, GALV, and RD114 envelopes
- Lentiviral E1a and SV40 virus T antigen
- Insertion Site Analysis
- PERT Assay
- p24 ELISA
