chapter  15
33 Pages

Management of Process Technology

ByDonald G. Bergmann

The measure of success of a large-scale cell culture manufacturing process is the ability of that process to be reliably operated at scale and within the confines of current regulatory environments. The first step of a successful manufacturing process lies in the process design itself. However, poor management of the process technology can cause an otherwise well-designed process to be unreliable in practice. The chapter outlines some of the important considerations and procedures that have been applied to successfully operating cell culture process plants. Traditionally raw materials (especially media and serum) are tested both by typical chemical analyses and by the performance of cells when cultured with the materials in question. The assurance that raw material vendors operate within the confines of good manufacturing and laboratory practices is sound economic practice and expected by the Food and Drug Administration (FDA).