With more than 50 components in culture media, screening and studying all the combinations to find the ideal formulation is labor-intensive, costly, and time-consuming.

The choice of components and parameters—such as temperature, mixing, and pH—can significantly affect media quality and the maintenance of a consistent and performant cell culture.

In-line and offline accurate measurements are performed throughout media optimization.

Therefore, process analytical technology (PAT) and design of experiment (DoE) are often necessary to develop a robust process and an ideal media formulation.

A successful downstream processing (DSP) process pipeline depends on the quality of the therapeutic design and the upstream processing as well as a cascade of well-designed and operated separation, purification, and formulation strategies.

With the increasing pressure to boost productivity and reduce the cost of goods, scientists are developing processes to enable faster regulation and commercialization of the biomolecules.

They are adopting new technology such as single-use technologies to reduce finished costs and simplify the process, inline process analytical technologies to streamline and integrate the analytical data (mainly pH, flow, pressure and conductivity), weight-based process automation, and process modeling to deepen the process understanding and control and achieve greater process insight on continuous processing methods.