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Optimal process conditions are critical for production for the production of a quality viral vector product. The goal of upstream process development is to establish a process with optimized viral productivity. Creative Biogene is committed to helping clients establish a flexible, scalable and cost-effective viral vector manufacturing process in the upstream development of viral vectors.
To reduce overall manufacturing costs, the goal from an upstream bioprocess development perspective is to establish a process with optimized viral productivity. With this in mind, a guiding principle is that the more cells that are used as substrates, the more viruses will be produced. Furthermore, the aim is to keep the cells in an optimal physiological state for virus production. Therefore, the main goal of upstream process development is to generate as much cellular material as possible while maintaining the cells in a state of optimal viral productivity.
The upstream production process of viral vectors includes cell expansion, virus seeding or plasmid transfection, and the culture of viral vector-producing cells. Throughout the upstream process, we utilize a design of experiments (DoE) approach to evaluate the impact of multiple factors and optimize the parameters of the production process to provide our clients with an efficient, cost-effective, and scalable upstream process.
Many factors influence the selection of cell lines used for vector generation. One key factor is the production titer. Increasing the production titer of a therapeutic vector can significantly reduce the production size and cost. Creative Biogene has an extensive resource of cell lines and offers optimized production cell lines. Among them, we offer HEK 293 cells with transfection efficiencies approaching 90% and they also produce high titer vectors.
Developing a high titer viral vector production process requires optimizing the cell growth process, including the culture system, media components and process parameters in culture. Creative Biogene helps to establish scalable cell culture processes to produce the required number of viral vectors to meet market demand. We offer adherent or suspension cell-based processes for viral vector production. To improve the efficiency of viral vector manufacturing, our scientists perform in-depth characterization of cell growth by better understanding nutritional requirements or facilitating process development efforts such as adapting adherent cells to suspension culture. Our selection of media provides the necessary nutrients to promote high productivity, consistency and quality, and can support scale-up to larger manufacturing platforms.
During process development, we start with small scale culture flasks to determine the optimal parameters and then scale up production with bioreactors. Typically, in the starting phase, we culture and expand suspension cells in shake flasks and expand adherent cells in T-flasks, HYPERFlask and HYPERStacks. To increase the number of cells, we achieve scale-up production with bioreactors and it is easier to detect and control the process, reducing record keeping and cell manipulation, reducing contamination risk and production costs for our clients. Our experienced experts increase productivity by improving the control of conditions in the bioreactor during production. In addition, our bioreactor systems can be used in perfusion mode and have become an attractive option for retrovirus and lentivirus production.
Determining the optimal parameters for viral infection or plasmid transfection is critical. Some of the key parameters include multiplicity of infection (MOI), time to infection (TOI) and time to harvest (TOH). We control the process by optimizing these parameters to maintain cell growth and viability and ensure optimal conditions for virus production.
As an experienced CDMO, Creative Biogene's extensive expertise and state-of-the-art facilities allow us to provide personalized viral vector upstream process development services based on the demands of our clients' projects. Please feel free to contact us if you have a need, and our experienced specialists will be happy to assist you.
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