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16 Pharmaceutical Technology ® Trends in Manufacturing eBook May 2023 PharmTech.com Cleanrooms Different flexibility needs Cleanroom infrastructures are commonly designed to meet the requirements of specific processing applica- tions. In these instances, f lexibility may not be a pri- mary focus. However, there are new therapeutic appli- cations that require a high amount of flexibility, as the processes are still not fully defined. Newly developed process technologies and modalities may enter the in- dustry, which can have an influence on the cleanroom infrastructure layout. In these instances, the cleanroom requires inherent flexibility within its design to accom- modate such process changes as they evolve (7). When one reviews flexibility in cleanroom infrastruc- tures, there is a clear opportunity to better define the different flexibility scenarios. There is not a one-size- fits-all flexibility, but a targeted approach that supports design decisions, construction mode, cost/delivery time certainty and value creation. Table I describes common flexibility scenarios as a basis for consideration. Notably, the list is not necessarily complete. But it shows that the word "flexibility" can have a much larger meaning and different understanding for different end-users and applications. Defining the true flexibil- ity needs on a per project basis allows for choosing the optimal solution, enhancing value creation. How cleanroom modalities meet flexibility needs Some traditional cleanroom infrastructures that are fixed-built on-site do not allow all f lexibility aspects. It has been recognized that stick-built infrastr uc- tures have a higher f lexibility, as the epoxy coated g y psum can be easily removed and reconfigured. However, the typical construction debris and poten- tial presence of mold require construction barriers, additional construction personnel f lows, and total rebalance of the area, thus diminishing the argument of easily reconfiguring (8). Reconfiguration can be lengthy, costly, and even detrimental when surprises are found during construction. It is of importance to review past experiences and compare such with newer technologies. There is also always the question of costs, and the best option is often the course that incurs the lowest costs. However, low cost does not come without compromises. Compromising on quality often leads to insufficient results and additional regulatory scrutiny. Ultimately, low cost will be rapidly overrun by the cost of bad qual- ity in multiples of any cost saving at the start. The other compromise is on f lexibility. Low cost may also mean a lower level of f lexibility and any sav- ings will be promptly off-set. For example, a clinical manufacturing infrastructure that is fixed-installed, typically for a temporary solution, becomes a sunk cost, not recoverable through re-use or movement to the end-site. Long-term planning and a detailed review of poten- tial future needs are required. When the process—or even unit operations—cannot be firmly defined, the call for flexibility is even louder. To support this effort, Table II lists the three main cleanroom modalities, noting the flexibility character- istics for each one from Table I. Hanns-Christian Mahler is Chief Enablement Officer (CEO) & Board Member, ten23 health. Andrea Allmendinger, PhD is Chief Scientific Officer at ten23 health. Considering Biologic Drug Development and Manufacturing Holistically Felicity Thomas, European/Senior Editor, talks to Hanns-Christian Mahler, CEO and board member, and Andrea Allmendinger, chief scientific officer, both at ten23 health, about some of the hurdles facing developers and manufacturers of biological therapies. Hanns-Christian and Andrea take a closer look at some of the solutions being used within industry to overcome these challenges and focus on the issue of sustainability within this sphere. Finally, they touch upon some of the other potentially important future trends that will impact biologic drug development and manufacturing. For more podcast episodes, visit our website! SCAN ME