Facilities

We have the capacity, technologies and experience to accelerate your cell and gene therapy development and manufacturing. We are continually investing in our molecular biology facilities to ensure flexibility and minimize time to trial and beyond for our customers.

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STATE-OF-THE-ART FACILITY

Indianapolis, Indiana

We manufacture your vectors in FDA-compliant gene therapy labs using validated processes. Our facility is 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.

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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.

Request a complete equipment list

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

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