A novel application of granulation technology to improve physical properties and biological performance of powdered serum-free culture media

摘要

The Advanced Granulation Technology (AGT) process was evaluated using serum-free and protein-free formulations containing ingredients believed to be sensitive to the ball-milling process. The AGT manufacturing process was scalable, based upon physical parameters, biochemical homogeneity and biological performance criteria. Cell culture growth and biological production studies involving CHO, Vero, hybridoma and HEK 293 cells demonstrated that serum-free/protein-free media derived from the AGT processsupported equivalent or superior performance to identical formulations produced by traditional processes. AGT meets pharmaceutical quality guidelines and can be applied to a broad range of nutrient formulations used in bioproduction applications.