Islands in the (Work) Stream
Single Use technology is a good way to realize flexible facilities within a short period. By customizing the automation, it is possible to use common standards to shorten the implementation- and test time, as well as a reduction of the effort for qualification. New technologies, like MTP (Module Type Package) will support this approach in the near future. To allow the analyzation of the production data an implementation of interfaces for data exchange with other systems (MES, historian,..) has to be standardized as well.

Factory of the Future Predictive Maintenance: Implementation of Wireless IoT Sensors at AstraZeneca's Largest Biologics Manufacturing Center
As one pillar of TPM program, AstraZeneca is driving the implementation of thousands of new wireless IoT sensors at their largest Biologics Drug Product facility in Frederick, MD. The project functions as example and the program will be scaled globally in future. The implementation leads to better predict failures of equipment and to avoid losses and unplanned downtime.

“Right First Time Manufacturing” Going Slower to Move Faster
In this presentation, we will discuss how incorporating dynamic computer modeling and simulations early on in the design process eliminated potential bottlenecks, improved the understanding of manufacturing and optimized material and personnel movement. The presentation will highlight Ultragenyx’s new gene therapy facility for rare and ultra-rare diseases that reinforces GMP compliance, improves operator experience and is designed for overall flexibility to accommodate multiple products and cell lines. As more gene therapy products move towards regulatory approval and commercial scale-out, manufacturers are turning to a new kind of production facility, one that’s flexible and future-ready, capable of adapting quickly as the industry evolves and new technologies emerge.

Amidst an ever evolving workforce and ways of working, changes in career progression, risk-taking, generational differences and mentorship have all played a role in the career landscape today. These changes have opened the way for individuals to innovate in their own career path and relationships, but also for organizations to listen to their employees' necessities and innovate to attract diverse talent. In this session, we explore these changes and evolving necessities and how three women leaders in the pharmaceutical industry have adapted.

Building an In-House Cell and Gene Therapy Manufacturing Facility during the Pandemic
The impact and disruption caused by the COVID-19 pandemic added an unprecedented level of risk and complexity for companies like Expression Therapeutics who were in the midst of constructing a new manufacturing facility. By taking a flexible project execution approach including pre-fabricated cleanrooms, the company was able to adapt to the situation and overcome the challenges ultimately resulting in the successful completion of the project on time and under budget. The project case study will be presented.