Cell Therapy Manufacturing

For gene-edited cell therapies, a seamless transition from viral vector production and lot release to cell therapy manufacturing is critical. To ensure that you receive the highest level of support, we have forged robust partnerships with a world-recognized cell therapy CDMO.

Expertise

Our years of expertise with lentiviral vector and retroviral vector production, deep understanding of the target cell therapy, long-standing industry experience, and history of academic-industrial partnerships have allowed us to establish close partnerships with experienced cell therapy manufacturers operating directly at the point of care.

Cell Types

  • CAR T, NK, T lymphocytes, and other immune cells
  • Hematopoietic progenitors and stem cells, including MSCs
  • Embryonic and induced pluripotent stem cells (iPSCs)

Services

From bench to clinic, our cell therapy cGMP facilities and manufacturing partners specialize in small-batch production. Alongside our partners, we provide comprehensive and flexible support tailored to your project’s needs. These collaborations allow us to tap into a vast pool of knowledge, experience, and cutting-edge technologies, enabling us to advance your therapies to the clinical stage efficiently. By leveraging these alliances, we help you navigate the complexities of the manufacturing process and accelerate the progression of your therapies from concept to reality within your project timeline.

Unique Cell Therapy Services

  • Enrichment or depletion of specific cell subsets
  • Genetic modification (transduction)
  • Expansion and differentiation
  • Cryopreservation
  • Cellular stability studies

Partnerships

Leverage our network of dedicated and experienced partners who can support your development and cGMP manufacturing facilitated and simplified by a Genezen project lead.

Cincinnati Children’s Hospital Medical Center Translational Core Laboratory

  • GMP aseptic cell transduction procedures
  • Certified ISO Class 7 production suites with ISO Class 8 support areas

Indiana University Gene Therapy Testing Laboratory

  • Patient testing
    • RCL Replication Competent Lentivirus (RCL) PCR-based testing
  • Biologic Replication Competent Virus
    • RCL
    • Replication Competent Retrovirus (RCR)
  • PCR Testing
    • VSV-G, GALV, and RD114 envelopes
    • Adenoviral E1a and SV40 virus T antigen
    • VCN
  • Insertion Site Analysis
  • LAM PCR analysis

Explore Genezen

cGMP Viral Vector CDMO Services

With unique expertise in cGMP lentiviral, retroviral, and AAV vector manufacturing, paired with a new state-of-the-art facility, we have the capacity and know-how to support your viral vector manufacturing needs.

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Testing

Clinical trial patient sample testing and cell line release testing are readily available to minimize your gene or cell therapy’s time to clinic.

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