The FinVector Facility

FinVector Vision Therapies viral-based manufacturing operations based in Kuopio, Finland provide process development and manufacturing for internal FinVector programmes and also for third-part clients at a variety of stages of therapeutic development.

 

The facilities, licensed by the Finnish medicines agency, Fimea, comprise three self-contained manufacturing suites, all able to accommodate biosafety level 2 (BSL-2) products. At these facilities FinVector can offer process development, cGMP manufacture of bulk drug substance, fill and finish and release testing with potential to access to FinVector’s unique platforms in adenoviral and lentiviral vector production.

 

The manufacture is supported by QA supervision and QC control of materials and products and an in-house QP for clinical and commercial release. These manufacturing capabilities are purpose-built alongside FinVector’s research and development laboratories. The synergistic operation of these disciplines allows FinVector to a complete service from research to commercial supply of gene-based medicines and other bio-therapeutics. This expertise enables FinVector to partner with its clients through any or all phases of product development, from research, through clinical trials and into commercialisation.

 

Our manufacturing solutions for viral based products:

 

  • Cell line development and optimisation
  • Vector development
  • Process development in adherent or suspension-based culture
  • MOI and DOI studies, process optimization and scale-up
  • Assay development
  • cGMP Manufacture of drug substance and drug product
  • Automated and manual fill and finish capabilities
  • Stability studies
  • Regulatory Consulting, IND, CMC & BLA applications
  • Cold chain distribution