Viral Vectors (including Adeno, AAV, Lenti)
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.
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.
- Basic small scale production method, based on adherent cells and the use of different size of cell culture flasks, for the preclinical and clinical manufacture of adeno-based products - which has already been approved for supply within the EU
- FinVector has developed a suspension-based scalable platform process for the preclinical and clinical manufacture of adeno-based products. This platform can provide clients with key benefits, including serum-free growth, and a high yielding product. This platform has already been utilised for production of different adeno products at various stages of clinical trials in EU and elsewhere.
- Novel scalable production method is based on fixed-bed bioreactor providing very large scale batch manufacturing in adherent mode - late stage process optimization/qualification is ongoing.
- FinVector has develop also several Single Use System (disposables based) downs stream processes for recombinant adenovirus vectors. Small scale downstream process can still contain gradient ultracentrifugation based purification of the vector. Scalable and cost effective large scale purification is based on chromatography and tangential flow filtration.
- FinVector has available independent suites, which can be used to carry out small-scale manual fills and also a larger suite which has a fully automated fill line which is able to carry out medium-scale fills for clinical and commercial use.
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:
- Easy, consistent and scalable production of baculoviruses in serum and antibiotic-free conditions is suitable for supplying the materials for cGMP manufacturing of lentiviral vectors for clinical use.
- The separation of the lentiviral genome components into four different baculovirus constructs minimises the possibility to generate replicative lentiviruses.
- New transgenes can be easily introduced into baculovirus constructs and hence readily incorporated into the production process.
- Baculoviral-based lentiviral vector manufacturing in suspension cells allows the use of bioreactors which provide an upstream process that is easily scalable and cost effective.
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.
Adeno Associated Viruses (AAV)
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.