A flexible toolkit to support cell line development for intensified processes
Bringing new therapies to the market requires a combination of “fail fast” approaches with development flexibility and de-risking strategies to shepherd the most promising molecules to the clinic as quickly as possible. Unlike traditional blockbusters, many new biotherapeutics are developed for more focused applications with smaller markets. This puts increased cost pressure on individual products and pushes the need for multi-product facilities to recover investments. At the same time, many new product modalities offer increased potency and selectivity, but often demand more stringent stability of process conditions to ensure product stability, economical yields and consistent product quality. This challenge is not easily met with traditional fed batch platforms.
Intensified processes provide an attractive opportunity to address these challenges. In this webinar, we introduce a service toolbox enabling streamlined development of CHO cell lines for different molecule types. It flexibly links modular routes from DNA to Research Cell Bank, MCB manufacturing, and early upstream development and includes options for intensified processes.
We illustrate how production clones for different product variants can be flexibly selected in their target process format like fed batch or perfusion. Early consideration of product quality traits and clone-specific properties affecting process scale-up is used to de-risk USP development. Pre-defined platform protocols for different process variants like high-inoculation fed batch are shown to facilitate fast process set up and scale-up. We demonstrate how intensified processes can be fine-tuned quickly in appropriate scale-down models using highly parallel Ambr® minibioreactors. Moreover, you will see how a matching cell banking approach with high density cell banks helps to realize shortened seed train times.
This combination of toolbox elements enables customers to flexibly choose the best cell line and process type tailored to their molecule of interest while offering to reap the full benefits of increased productivity, improved facility utilization and lower cost of goods afforded by intensified processes.
If you think such a flexible toolkit could also be a good match to your process development needs we invite you to register for this webinar!
Presented by
Dirk Müller,
Manager Product Development Media and Process
Dirk Müller heads a product development team at the Cell Line, Media & Testing Solutions (CMTS) unit of Sartorius. His team develops media and different process formats for CHO cells. Before joining Sartorius, he has worked in several positions at Insilico Biotechnology, a company specializing in optimization of bioprocesses using predictive cell models. Dirk holds a Master’s in chemical and process engineering and a PhD in biochemical engineering.