Historical reflections on cell culture engineering

Cell culture engineering has enabled the commercial marketing of about a do zen human therapeutic products derived from rDNA technology and numerous mo noclonal antibody products as well. A variety of technologies have proven u seful in bringing products to the marketplace. Comparisons of the technolog ies available 15 years ago are contrasted with those available today. A num ber of improvements in unit operations have greatly improved the robustness of the processes during the past 15 years. Further evolution of the techno logy is expected in several directions driven by commercial and regulatory pressures. Some problems remain for the next generation of cell culture eng ineers to solve.