Variability in cell culture media can directly affect the biotherapeutic manufacturing process performance and drug substance quality. This variability is magnified not only by the impurities introduced by the raw materials, but also by the physical parameters such as type of mixing vessels, temperature and power density for mixing, as these parameters directly impact the chemical reaction kinetics. Though cell culture medium is usually released on the basis of offline analysis such as pH and osmolality, these methods are incapable of capturing the intricate media chemistry that occurs due to the changes introduced by medium mixing parameters or raw material impurity, thus rendering an unknown vulnerability in the manufacturing process. Applying online analytical tools in characterizing medium preparation can detect the media quality and potentially help understand the underlying mechanisms of media variability. Further, using the online analytical tools for different scales can support a more informed technology transfer from development to manufacturing, and thus helping to improve the robustness of cell culture process. In this presentation, we will share our strategy and case study on using such tools in characterization of medium preparation.

Subject area:
Biologics

Objectives (If applicable):
N/A

Target Audience (If applicable):
Analytical chemists
QA/QC analysts
R&D scientists, managers
Team members in CMC development projects
Manufacturing scientists, managers
Regulatory affairs specialists
Contract research organizations
Contract manufacturing organizations