cGMP Manufacturing Capabilities

FinVector has extensive experience in cGMP manufacturing. Since FinVector was established more than 20 years ago, we have produced multiple cGMP batches for viral Gene Therapy products in adherent and suspension-based campaigns.

FinVector will share all of our invaluable knowledge and experience with clients. We will act as your long-term strategic partner, offering guidance and support as your product travels from the laboratory, through clinical trials to the commercial market.

Our state-of-the-art facilities comprise three self-contained cGMP manufacturing suites, all able to accommodate products requiring biosafety level2 (BSL-2). The facilities, which have a commercial license from Finnish medicines agency (Fimea) allow us to offer a wide range of services. These include process development, cGMP manufacture of bulk drug substance, aseptic fill and finish, and QC release testing.

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.

Qualified Person Release and more

FinVector offers qualified person release of drug products to warehouse. We work closely with qualified couriers for cold chain distribution, and together we can transport your drug product to your facility or directly to your distribution or clinical site. We also have expertise in Pharmacy Manual preparation especially for the handling of gene-therapy products in pharmacies within Europe.

We offer the following services for Viral Vectors:

  • cGMP Master and Working Cell Banking
  • cGMP Master Virus Seed Stocks
  • Adherent and suspension cell culture
  • Ultra/diafiltration
  • Depth filtration
  • Chromatographic purification
  • Ultracentrifugation
  • Formulation
  • Manual and Semi Automated Fill/Finish (350 -2,000 vials/hour)
  • Stability Studies
  • Testing and QP release