Preparing For Success: Chemistry And Component Optimization In Early-Stage Biopharmaceutical Development

Once you have cleared the preclinical stages and are ready to scale up to cGMP manufacture, it becomes crucial to retain consistency, safety, and efficacy of your media formulation. Optimization is an important strategy for making sure that your cell culture medium can perform well at scale and support a high cell density. To do this, both the media chemistry and components must be assessed and refined at an early stage prior to cGMP manufacture.

This requires extensive consideration of how best to optimize cell culture media for high performance, whether you want to achieve higher titers or certain protein quality attributes. In addition, end product optimization also requires deliberation over other factors, including the manufacturability and quality of media components.

Continue reading to learn more about important considerations for optimizing your media chemistry.