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Pharmaceutical Technology TRENDS IN MANUFACTURING 2022 eBOOK 45 Another important driver for cost reduction and faster supply to patients is the strategy of scaling out instead of scaling up (see Figure 2). To date, manufacturing equipment in development and commercial manufacturing differ significantly from each other, because development focuses on high f lexibility and handling of small batch sizes, whereas commercial manufacturing relies on eco- nomic and speedy production equipment. In the scale-up approach, once a product is transferred from development to a manufacturing site, time- consuming qualification and validation activities need to start from scratch and thus are in the way of a fast patient supply. In the scale-out approach, by ensuring that equipment and processes are identical from development to commercial manu- facturing and standardized across the company's network, the technology transfer of a new molec- ular entity from development to the commercial manufacturing site can increase significantly, if technical equivalency is given. Higher volumes are no longer compensated with larger or faster equip- ment, but with the addition of more and identical equipment, often as closed unit operations in a "ballroom concept" manufacturing environment. Greater standardization and less individuality lead to a faster transfer of the process. By substi- tuting manual work that is subject to individual procedures with robots that ensure repeatability and reproducibility of these activities, the entire process becomes more robust, and tech transfer efforts can be reduced significantly. As another important driver for the increased implementation of robotic technology in pharma, the COVID-19 pandemic has shown how vulner- able an industry can be and how quickly opera- tions continuity can be at risk given an unforeseen sickness ratio or sudden lockdown restrictions that would limit human operators. Robotic automation does not have the same restrictions and would re- duce this vulnerability. A holistic picture For a drug manufacturing company, introducing new technologies, such as robotics, to the manu- facturing process requires taking multiple factors into account. Regulatory requirements impact the introduc- tion of robotics. The authors hypothesize, how- ever, that regulatory requirements are not the only and possibly not even the main reason for the hesitant adoption of advanced automation and robotics in the pharmaceutical industry. The introduction of robotics is much more hindered by a hesitancy toward a mindset change of the industry including its ecosystem, which often falls short due to complexity and different per- spectives or priorities within the various parties involved. The aim of the last section of this article is to shed light on ways to reduce complexity. Two assumptions underlie the following pro- posed strategy. First, there are no physical bound- aries to what a robot can do for the selected use cases, making it possible to convert any human activity into an automated process. Other indus- tries are an indicator that advanced automation is realistic to achieve. Second, robotics and conver- gent technologies will rapidly evolve over the next five to 10 years, creating further opportunities for integrating robotics in pharmaceutical manufac- turing. Hence, some of the concepts the authors describe may not be available yet. As previously indicated, the introduction of robotics is not different from any other inno-