The demand for viral vector-based products is growing rapidly. However, there are still manufacturing challenges which hamper the development of these promising new therapies. A major problem is low product yields. For many medical applications, a certain minimal dose of product is needed to have a clinical effect. With low production yields, it is a challenge to get enough product concentrated in one syringe.
Highly intensified manufacturing
Additionally, low production efficiency necessitates large volume production to obtain sufficient doses, resulting in high cost of goods. For instance, many viral vectors are produced by adherent cells that are cultured in cell factories, but this legacy technology can only be scaled out rather than scaled up, and no significant reduction of cost of goods can be achieved when larger numbers of cell factories are used to obtain more product. To address this problem, we developed highly intensified manufacturing processes.
By means of bioprocess intensification, we are able to:
- Reduce facility footprint (CAPEX),
- Reduce amount of labor and consumables required (OPEX),
- Reduce total process times.
HIP-Vax offers a complete solution for a variety of viral vector platforms, including adenoviral vectors and lentiviral vectors. The package includes:
- cGMP compliant protocols for intensified production and purification processes,
- Optimized producer cell lines,
- cGMP compliant virus seeds.
The processes are designed to deliver large volumes of viral vector drug substance at a low cost of goods.
HIP-Vax production process characteristics
The production process uses a novel bioreactor design (scale-X™), able to support high cell densities and vector yields per bioreactor volume. In addition, high efficiency of downstream recovery with limited process steps results in an optimized purification process. Finally, all required analytical assays for release, characterization and stability testing of products are in place and ready for use. Combined with our state-of-the-art process intensification expertise, this can increase process output up to 20-fold. As a result, HIP-Vax allows significant miniaturization of the manufacturing facility through which commercial manufacture at lab scale is possible, thereby significantly reducing the cost of goods for the manufacture of viral vectors.
Whereas we offer our research and development services for any customer-specific vector, we also have HIP-Vax processes in place that are available for licensing. Please contact us for more information.