FinVector has extensive experience in cGMP manufacturing. Since FinVector was established nearly 30 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 four self-contained cGMP manufacturing suites, all able to accommodate products requiring biosafety level 2 (BSL-2). The facilities, which have a commercial license from the Finnish medicines agency (Fimea) allow us to offer a wide range of services. These include process development, cGMP manufacture of bulk drug substances, 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
FinVector offers qualified personnel release of drug products to the 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.
Thaw and Expand Cells and Seeds
First stage of the process is cell culture and this process begins with thawing of a cryopreserved cell-bank vial. The cell bank vial is considered the crown jewels for the product.
Media & Inoculum Prep
This process preparation involves obtaining the organisms in an optimal state that is compatible with inoculation into cell culture, media and fermenters by providing a viable biomass capable of high productivity.
Cell Growth & Virus Production
Followed by successive expansions into larger culture vessels such as shake flasks, spinners, Wave bags, and stirred bioreactors. When culture volume and cell density meet predetermined criteria, the culture is transferred to a production bioreactor in which cells continue to grow and express product.
A virus bulk harvest is the batch of cells, media and product which is derived from the manufacturing process at the end of the upstream process and prior to downstream purification takes place.
Combine biomass removal with contaminant clearance is the first purification step. It is critical for early removal from contaminants such as DNA enables a lean downstream process train. An efficient clarification step separates the virus from the cells, cell debris and many impurities including insoluble precipitants, aggregates and other materials found in typical cell cultures.
Tangential Flow Filtration is used for pre-concentration and dia-filtration pre chromatography.
Column chromatography is the most powerful and versatile method for Ad and AAV purification. The yield, purity and biological potency of the final viral product resulting from chromatography-based purification schemes surpass that of conventional CsCl purification.
Affinity chromatography is capable of separating viral particles from protein and DNA contaminants based on a reversible interaction between the viral capsid and a specific biological ligand or receptor coupled to a chromatographic matrix.
Post chromatography Tangential Flow Filtration is used for concentration and formulation of the virus into the final formulation buffer which is then suitable for storage and administration into patients.
Fill & Finish
This process is final step for a product post upstream and downstream. Aseptic liquid fill into a vial is an important step for any drug product and is carried out in a grade A environment using an automated fill line. Once the drug product is filled it is then inspected, labelled and packaged into its relevant packaging.