From Science and Engineering to Regulatory Requirements

systems play an essential role in today’s biopharmaceutical processes. Recombinant E. coli and yeast systems are dominant tools in early discovery of effective medical targets. These systems are also routinely used to produce biological reagents for analytical methods in research and quality controls of products. In the biopharmaceutical industry, microbial systems have delivered major medicines such as blood proteins (factors VIII and IX), G-CSF, tPA, recombinant hepatitis B vaccine, interferons, interleukins, and human growth hormone (1). Microbial systems continue to improve to meet the challenges in expressing new and more complex biomolecules (2, 3). The advantages of microbial systems over mammalian systems are clearly recognized for their short development cycles and substantially lower manufacturing costs. Microbial process development is an integrated activity involving science, engineering, and regulatory requirements. Process development professionals must master microbial science and technology and thoroughly understand key quality issues and regulatory drivers.