Genezen 
9900 Westpoint Dr, Suite 128
Indianapolis, IN 46256
T: (317) 822-8330
E: info@genezen.com
W: www.genezen.com
LinkedIn: https://www.linkedin.com/company/genezen-laboratories/
Twitter: @GenezenLabs https://twitter.com/GenezenLabs

 

Specializing in lentiviral and retroviral vectors, Genezen offers early-phase process development, GMP vector production, analytical testing services and assay development. Leveraging the expansive knowledge and experience of its team, Genezen accelerates cell and gene therapies to commercialization and helps deliver life-changing therapeutics to patients.

Founded in 2014, the company strives to make viral vector production accessible to early-stage, growth-oriented companies and established industry leaders.

Genezen officially opened its 25,000-square-foot, state-of-the-art, cGMP-compliant process development lab in late 2021. Situated in the fast-growing life sciences hub of Indianapolis, the laboratory is the first phase of a larger cGMP-compliant lentiviral and retroviral vector production facility which will house multiple cGMP production suites with capabilities for host cell expansion and banking and viral vector production.

SERVICES

Process Development

  • Transient transfection and plasmid system options
  • Producer cell line development
  • Plasmid design
  • Selection of viral vector platform and cell line for vector production
  • Reproducible process design with commercialization approach

Process Optimization

  • Upstream and downstream processing
  • Proof of concept evaluation runs
  • Research cell banks
  • Engineering runs at variable scales for further optimization in the process development lab
  • Optimized cGMP runs
  • cGMP master and working cell bank productions

GMP Vector Production

  • Aseptic processing using single-use closed systems from upstream processing to fill and finish.
  • Adherent cell capability for up to 140L production
  • Roller bottles, cell stacks and fixed-bed bioreactor
  • Proprietary suspension 293T cell line for up to 200L production
  • Single-use/closed systems for virus harvest, purification and concentration
  • Access to cGMP compliant master cell banks for common cell lines including HEK293T

Testing

  • Potency: Biological titers, physical titers (p24), Empty vs Full particle ratio, transduction efficiency
  • Safety: RCL testing (co-culture and qPCR based), RCR (GALV, ecotropic and direct), endotoxin, mycoplasma, sterility, in-vitro viral assay, PERT
  • Identity: Vector Copy Number by qPCR, vector insert identity & stability, insertional site analysis, ADA Isoenzyme analysis
  • Stability: Cell line, viral vector and transgene studies
  • Residual testing: Benzonase, host cell proteins, host cell DNA, plasmid DNA, E1A qPCR, SV40 qPCR

Cell Manufacturing

  • Capabilities across,
    -CAR T, NK, T lymphocytes and other immune cells
    -Hematopoietic progenitors and stem cells, including MSCs
    -Embryonic and induced pluripotent stem cells (iPSCs)
  • Enrichment or depletion of specific cell subsets
  • Genetic modification (transduction)
  • Expansion and differentiation
  • Cryopreservation
  • Cellular stability studies
  • Suspension cell line development
  • Producer cell lines

 

Click here to view/download Genezen’s latest poster: Development of a Transfection-Based, Scalable, Serum-Free, Single-Use Suspension Platform for Manufacturing Lentiviral Vector