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Pharma Manufacturing production lines in those facilities. Two products with different unit operation processes were picked as part of our initial deployments — Lipitor (a wet granulation process) and Geodon (a dry granulation process). We also looked at some of the active pharmaceutical ingredients (API) processes for Lipitor, Lyrica, and Celebrex (which are all blockbuster drugs). LSL: WHAT WERE SOME OF THE LESSONS LEARNED FROM THESE DEPLOYMENTS? that not always to be the case with generics. The ability to produce variable quantities of medicines, as well as the ability to ramp up and produce more medicines very quickly, has enabled us to compete effectively in the generic area. While it is challenging to provide both quality and supply assurance while also having the lowest cost, we have found that customers are willing to pay a bit more for the quality and supply assurance we offer. LSL: WHAT PARTICULAR TYPE OF DATA ARE YOU EVALUATING IN THIS DECISION-MAKING PROCESS? KN: For starters, the business cases changed over time. It takes KN: You are generally looking for a comparison to the baseline some time to adapt and develop these applications. You start in for the product or unit operation. We usually have quite a bit of a pilot environment to develop data that convinces you it will data, because we have been running these unit operations for a work. Then you develop data to convince regulators so they will long time. The most compelling data is situations where continuapprove it as an alternate process. These activities take several ous processing can do something significantly better or years to work through. In our case, some of the busisomething that a batch unit operation can't do. One ness cases changed during this time frame. Though the example is the synthesis part of small molecule API. You deployments were technically very successful and effeccan do some exothermic reactions or hazardous reactive when installed for commercial manufacturing, some tions in a continuous-mode plug-flow reactor that you of the manufacturing sites are no longer in our network, could not do in a batch reactor for either safety reasons and the products have gone generic. When we look at or that the chemistry may be self-limiting. A second way the costs to relocate that technology to another site, it to look at it is if you are going to be incrementally better really didn't have a good ROI. The cost pressures from from either a labor or productivity perspective. Those generic competition changed the landscape. Today, are still strong business cases, but you have to when we approach a deployment, we do a much look beyond just the current situation with that more rigorous job of identifying and making "I think one of the best ways product. You probably need to look at least 5 to sure, up front, it has an enduring business case. to go about implementing CM 10 years down the road to determine whether We also look for projects that can be rapidly deployed on a number of products. It is difficult processes is to develop the analytics the benefit of implementation will still exist or accumulate. In situations where you need to have a project tied to one individual prodin line with the application." additional capacity for a product or a suite of uct, because as it moves through its life cycle, Kevin Nepveux, VP of global technology services, products, and you need to build more capacity, and generic competition begins, volumes drop Pfizer Global Supply it is important to consider developing continuand the cost environment changes. We look for ous processes, as I believe these applications are opportunities with broader applicability that can going to be significantly less capital-intensive, have a smaller footbe applied fairly quickly. print, and be more productive than building a large, traditional Another lesson learned involved analysis. For example, when we batch facility. At present, this is not generally the case, since we did Lipitor and Geodon, we did business cases comparing what have excess capacity for most of the traditional unit operations. we believed the technology would look like in five years, relative Where we are finding opportunities is in some of the smaller to how it was at the time, in terms of production costs, demand, emerging markets where, either for tactical or political reasons, margins, etc. In conducting our analysis, as we were the only you are looking to establish a local manufacturing presence. manufacturer of the drugs, we used ourselves as the comparator with which to benchmark. Now, when a drug loses exclusivity, you LSL: WHAT ARE SOME OF THE ADVANTAGES OF are no longer competing with yourself, but with generic manufacCONTINUOUS VERSUS BATCH MANUFACTURING turers, which often have much lower labor and capital costs. As a PROCESSES? result, shortly after we had developed and implemented the CM KN: In CM you can operate at a steady state, which is optimal for process for these drugs, our analysis was no longer valid because that process or unit operation. Batch, by definition, is a transition the benchmark had shifted from internal to external. from a starting point, through a process, to an ending. There Pfizer's value proposition hinges on quality and supply assurmay be a point along the way where it is optimal: a "sweet ance. We excel in manufacturing the highest quality products and spot" for that specific process (i.e. a chemical reaction, forassuring their supply globally. A lot of the customers have found 44 LifeScienceLeader.com September 2013