FinVector’s unique facilities, matched with the extensive experience of our scientific team, enables us to work with a broad range of viral vectors, especially Adenoviruses (recombinant, oncolytic), Adeno Associated Virus (AAV) and Lentivirus.
Adenoviral vectors are the most frequently used vectors in gene therapy clinical trials. Adenoviruses have proven an efficient tool for the treatment of many type of diseases, such as cancer, vascular disease and monogenic disorders. The most commonly used adenovirus serotypes in gene therapy are 2 (Ad2) and 5 (Ad5). Adenoviruses infect both dividing and quiescent cells having broad tropism and transient transgene expression. The viral particles are rather stable and easy to manipulate. In addition, adenoviral vectors can be produced in high titters.
FinVector has a unique capability to provide complete material and documentation packages from research through development to commercial production in compliance with cGMP requirements. FinVector has prepared viral vectors and seed stocks for materials which have been used in Phase I-III clinical trials in the USA and Europe and has proven expertise in the development, the chemistry manufacturing and control (CMC) of biologicals, and information required for the common technical document (CTD) submission to the European Medicines Agency (EMA). For Adenoviruses, FinVector has developed several different production methods to be able to produce vectors for many gene therapy applications.
Lentiviruses have valuable capabilities as vectors in gene therapy. This is because they have low immunogenicity and transduce both dividing and non-dividing cells with high efficiency, achieve long-term stable expression of the transgene. This gives lentiviruses a wide range of potential therapeutic applications. However, the generation of clinical grade vectors in quantities large enough for therapeutic use is still challenging and often limiting for preclinical and clinical development projects. To solve this unmet need, FinVector has established and patented a practical means of manufacturing lentiviral vectors in suspension cells using baculovirus constructs to supply the genetic components.
The advantages of the baculovirus-based production method are:
In addition, FinVector is advanced with a fixed-bed bioreactor approach. The iCellis technology provides controlled and disposable manufacturing between scales of 0.5-500m2. High plasmid transfection efficacy, leading to high lentivirus yield has been achieved with this system using adherent cells.
The non-lytic adeno-associated virus (AAV) has evolved into a gene therapy tool of considerable importance since it has been used in a wide range of gene therapy approaches. AAV has a broad host and cell type tropism and it transduces both dividing and non-dividing cells. So far AAV vectors has been manufactured for preclinical studies. FinVector has several areas that are dedicated for viral vector process development suitable for upstream and downstream work and several campaign based cGMP facilities.
FinVector is very experienced in growing HEK293 and 293T cells in several manufacturing systems, in adherent or suspension, flasks and bioreactors, with serum or in serum-free conditions. FinVector has a proven capability in producing AAV using plasmid-based production systems in adherent or suspension mode using either flasks or scalable bioreactors. Our work with a fixed-bed large scale bioreactor is providing a novel system for adherent process upscaling with good transfection efficiencies. FinVector has also a baculovirus-based production system in insect cells.
FinVector’s process development, cGMP manufacturing, analytical development and process validation capabilities have been developed through the supply of its own and client´s clinical products for gene-based clinical trials. Altogether this knowhow and our state of art facilities reassures clients that FinVector provides an excellent site to take AAV products into the commercial market.
For a greater understanding of our viral vector capability and process experience we would welcome any enquiries.