Process Development for Vaccine Production
The generation of high titer vaccines with acceptable purity is a challenging task, both regarding upstream and downstream steps.
Upstream development uses well established technologies such as bioreactors (e.g., single use) or high-cell density systems based on microcarrier technology. An integral part of process development is the fine tuning between cell substrate, virus parameters and growth conditions with the goal to achieve high product titers.
The general approach in downstream development is to use a sequence of unit operations such as column chromatography, ultracentrifugation and/or ultrafiltration. Therefore, a simple and efficient sequence of steps can increase product yield and quality.
Upstream Development:
High-Yield Virus Production
Based on our long experience in vaccine manufacturing and process development, we optimize and implement upstream production methods using a variety of systems (T-flasks, spinner culture, cell stacks, bioreactors and high-density bioreactor systems) on a lab scale. This includes the establishment of accurate and fast titer assays enabling efficient process optimization.
Downstream Development:
Simple and Fast Purification Process
Nuvonis has developed simple and highly efficient purification procedures based on a combined precipitation step or column capture, resulting in
- Infectious titer yield: >75%
- DNA depletion: > 99%
- Total protein depletion: ~95%
One Step-Purification for Influenza and Newcastle Disease Virus (NDV)
Together with our partner BiaSeparations we have developed a One-Step Monolith Virus Purification process that is extremely fast and efficient for a variety of influenza viruses. Also, a fast method for Newcastle Disease Virus purification was developed.
Influenza Virus Generation by Reverse Genetics
The generation of influenza viruses by genetic mechanisms can significantly speed up the vaccine generation process. Nuvonis uses a proprietary method to generate vaccine strains within days in certified serum-free Vero cells. This method is extremely fast, efficient, and reliable for vaccine production.
Use cases (> 500 viruses developed so far) are:
- Generation of virus strains for preclinical research
- Generation of strains for process and yield optimization
- Generation of vaccine/vector strains for GMP manufacturing (clinical trial material)
Consulting
Based on our long experience in vaccine manufacturing and process development, we offer consulting services for all aspects of virus manufacturing, from cell and virus banking to up- and downstream processing.