09.29.21 -- Considerations For A Successful Process Development

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 at production scale. This article describes a straightforward way to achieve a high-performing fed-batch process.

Time-to-experiment, time-to-clinic, and time-to-market are becoming even more important for developers and manufacturers of biopharmaceuticals. Here we give some insights on tools to make process development more efficient.

Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production. Learn how several different approaches and technologies can improve the efficiency of upstream processing, including cell line development, process development, process intensification, real-time analytics, and process integration.

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.

In the current biopharmaceutical landscape, developers are constantly encountering new and diverse biological molecules with complex structures. Understanding what challenges these diverse molecules can create and how to manage these challenges is key to ensuring they reach patients safely and efficiently.