New GMP capacity under construction for early 2021. Talk with us about how to utilize our cleanroom availability to produce your vector quickly and reach clinical trials sooner.
PARTNERING WITH TOP ACADEMIC INSTITUTIONS
Genezen has master service agreements with the labs at Indiana University, the Centre for Commercialization of Regenerative Medicine, and Cincinnati Children’s Hospital Medical Center.
Together, they provide the contract laboratory and storage facility services we provide. Researchers with Qualified Person (QP) Certification and extensive HIPPA compliance training run both facilities.
CINCINNATI CHILDREN’S HOSPITAL MEDICAL CENTER
translational core laboratory
The Cincinnati Children’s Hospital Medical Center Translational Core Laboratory has been assisting in translating innovative processes from bench to bedside since 2003 with a focus on manufacturing and testing for cell and gene therapy clinical trials. They offer production of GMP grade retroviral and lentiviral vectors, generation of stable producer lines, and quality control testing including vector titer by functional assay FACS or PCR, mycoplasma, and sterility testing. They can also help you develop and scale up your ex-vivo gene transfer and cell therapy clinical trials.
CENTRE FOR COMMERCIALIZATION OF REGENERATIVE MEDICINE
Centre for Cell and Vector Production at CCRM
The Centre for Cell and Vector Production, a world-class GMP facility built in partnership with University Health Network, includes 10 suites — two dedicated to AAV, lenti- and retro-viral vectors — in a 20,000 square foot facility. The ISO Class 7/Grade B clean rooms are used for production of materials to support Phase I and II trials. The 40+ staff with 100+ combined years of experience in cell and gene therapy manufacturing offer production and release of cell and viral vector materials and cell bank creation.
cell and gene therapy manufacturing Facility
Gene therapy testing Lab
The Indiana University facility was established in 1995 with the goal of generating clinical gene therapy vector products. To date it has certified over 50 products for Phase I/II trials.
This cGMP-compliant production facility contains three production suites that are dedicated and optimized for GMP grade retroviral and lentiviral therapy vectors for clinical use. Testing is also available for assistance in gene therapy clinical trials.
For more information on our services, contact us at firstname.lastname@example.org or submit this form.
9900 Westpoint Dr, Suite 128
Indianapolis, IN 46256
Noyes Pavilion, Lab E536
1800 N. Capitol Ave.
Indianapolis, IN 46202