cGMP suites specifically designed for maximum productivity and efficient production
FDA and EMA
Midwest location with logistics hub resources
Additional planned expansion
Flexibility to partner for later stage joint ventures
We are dedicated to utilizing the highest standard in technology to advance your project efficiently and ensure you are ready for regulatory scrutiny.
- In-house, validated technology
- Advanced vector equipment
- Lentivirus expertise and resources
PARTNERING WITH TOP ACADEMIC INSTITUTIONS
Genezen has master service agreements with the labs at Indiana University and Cincinnati Children’s Hospital Medical Center. Together, they expand the contract laboratory and storage facility services we provide. Researchers with Qualified Person (QP) Certification and extensive HIPPA compliance training run both facilities.
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.
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 email@example.com or submit this form.
9900 Westpoint Dr, Suite 128
Indianapolis, IN 46256
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