PREMIER INHOUSE FACILITY

We manufacture your vectors in FDA and EMA compliant manufacturing facilities using validated processes. Our brand new 25,000 sq. ft facility is equipped with cleanrooms specifically designed to expedite your gene therapy developments.

Design

cGMP suites specifically designed for maximum productivity and efficient production

Compliance

FDA and EMA

Accessibility

Midwest location with logistics hub resources

Size

Additional planned expansion

Flexibility to partner for later stage joint ventures

STATE-OF-THE-ART TECHNOLOGY

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.

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.

INDIANA UNIVERSITY

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.

QUESTIONS?

For more information on our services, contact us at info@genezenlabs.com or submit this form.

Address:

Genezen Laboratories
9900 Westpoint Dr, Suite 128
Indianapolis, IN 46256

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