08.10.23 -- Biomanufacturing Process Optimization And Scaling

Cytiva's seasoned scientists and team leaders present the latest trends in cell culture technology, as well as strategies to accelerate cell line development, media development, and raw material characterization. Additionally, they discuss tools and enablers for scale-up and the benefits of outsourcing process liquids and buffers.

Identifying some key items about your cell line from the beginning, such as the nutrients it needs over the culture time, impact of metabolites, and critical osmolality, can help to rapidly design a simple daily feeding regimen to perform a production scale. We describe a straightforward way to achieve a high-performing fed-batch process.

The transfer of a monoclonal antibody production process between scales is a difficult task. In this study, we leveraged existing physical characterization data and scaled a process from microbioreactor scale to production scale. We show the physical operating parameters and present both cell culture and product quality data across all scales.

The ability to scale seamlessly between bioreactor sizes helps to ensure product quality and de-risk scaling activities. Here, we provide an overview of the theory of scaling, present workflows and strategies, discuss which data are needed for successful scaling, and present case studies that use a web-based scaling tool developed by Cytiva.

To achieve long-term manufacturing success, it’s important to establish an optimized production process and outcome. We take a look at how the process outcome can be improved by increasing the performance and robustness of the bioprocess workflow through a variety of critical aspects, different strategic approaches, and innovative tools and methods.