Operational excellence principles. It took a long time for traditional small-molecule pharmaceutical companies to realize that operational excellence techniques and philosophies, long valued in other industries, also had tremendous potential in their businesses. It was postulated that small-molecule pharmaceutical manufacturing was different; therefore, what was applied in the automotive industry or small-component, high-volume manufacturing had no place in a highly regulated, complex manufacturing environment. The key to realizing the potential has been in developing process understanding and subsequently using this new knowledge to significantly increase process robustness and deliver manufacturing and supply-chain efficiencies. Techniques, such as Six Sigma and PAT, have allowed the industry to understand the relationships between critical process parameters and critical quality attributes like never before so that new control philosophies could be developed. Lean manufacturing tools, such as standard work, Single Minute Exchange of Die (SMED), Total Productive Maintenance (TPM), and 5S (Sort, Set, Shine, Standardize, and Sustain) have removed variability in the way unit operations are performed. Lean supply-chain thinking, pull systems, and Kanbans (scheduling systems that tell the user what to produce, when to produce it, and how much to produce) have facilitated strategic management of inventory. The result has been increased supply reliability, improved assurance of quality, and lower costs. All of these lessons can be similarly deployed in large-molecule manufacturing and related supply chains to achieve operational excellence.

Apart from the direct benefits of quality, cost, and supply reliability there also are indirect benefits. Adoption of operational excellence principles has given small-molecule pharmaceutical manufacturing a new language and facilitated benchmarking with other industries. For example, small-molecule pharmaceutical companies can now compare inventory turns, overall equipment effectiveness, and defect rates with other advanced manufacturing industries and use the same techniques that produced world-class performance. Also, the adoption of lean and Six Sigma tools is completely synergistic with the modern management and organizational philosophy of arming engaged and empowered work teams with vital skills to improve their work.

Innovation is crucial for advanced manufacturing. In the past, there has been a perception that the rigor of Six Sigma and the standardization of lean manufacturing could be an impediment to innovative thinking. In fact, the opposite is true. The process understanding provided by Six Sigma provides a platform for innovation and standardization, solidifies the benefits derived, and prevents the natural fallback from optimum performance. Standardization of the innovation process itself is key to embedding innovation as a behavior in an organization. As a relatively young industry, innovation is paramount to advancing biotechnology at a much quicker rate than that experienced in small-molecule development and manufacturing.