The vision of Life Science Leader is to be an essential business tool for life science executives. Our content is designed to not only inform readers of best practices, but motivate them to implement those best practices in their own businesses.
Issue link: https://lifescienceleadermag.epubxp.com/i/161331
Pharma Manufacturing Pfizer's Hybrid Approach To Implementing Continuous Manufacturing Processes By Rob Wright, chief editor W hen Kevin Nepveux joined Pfizer, his first job out of college was working as a production engineer manufacturing penicillin in one of the company's original plants in Groton, CT. Today, Nepveux is the VP of global technology services within Pfizer Global Supply. "Actually making the product and seeing it go into drums every day was very fulfilling," he states. Being close to where the action is may have been rewarding as a new employee, but as a senior leader he has found it to be even more important to understand how to best improve Pfizer's manufacturing processes. Nepveux sat down with me to share some of his insights about continuous manufacturing (CM) and how Pfizer is deploying continuous and batch processes as a hybrid approach toward improving manufacturing efficiencies. LIFE SCIENCE LEADER (LSL): DESCRIBE HOW PFIZER WENT ABOUT DEPLOYING CM TECHNOLOGIES. Kevin Nepveux (KN): The Global Technology Services (GTS) group initially started on these projects back in the late 1990s. The pharmaceutical industry environment was very different from today. The cost pressures were building, but weren't as severe, and our model was still that of the blockbuster. As a result, it was a more receptive time for developing and deploying these technologies than where we are today. When we started to look at CM 42 LifeScienceLeader.com technologies, we first looked outside of pharma. A lot of the continuous technology had been developed and deployed in other industries that had experienced cost pressures long before pharma. We weren't necessarily inventing anything new, but applying technologies from other industries to pharmaceuticals, recognizing, of course, that we typically have much tighter specifications and control ranges. The food processing and specialty chemical processing industries were good sources of ideas, as they use similar unit operations. The significant challenge was in adapting some of those technologies to pharma, as these industries have a different regulatory and cost environment and operate in much higher volumes. We would pick some of the unit operations that were the most broadly used throughout Pfizer that we felt most comfortable making continuous via adapting similar technologies from other industries. These were typically the common September 2013 unit operations, such as roller compaction within a dry granulation unit operation. The philosophy was, once you get that working for one product, it should be readily applicable to others, though it would usually require some additional customization or development depending upon the product. We would then pick a specific product we thought served as a good example of that unit operation. For the most part, these were usually high-volume, capital-, and labor-intensive products, with a fixed set of unit operations performed in a batch mode — the low-hanging fruit, if you will. We would develop the continuous option at a small laboratory or pilot plant, along with the site that was manufacturing the product to verify that it worked and to uncover the various challenges that would have to be overcome from either an engineering or a technology perspective prior to scaling up. In three or four cases, we built CM commercial-scale setups or