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42 Pharmaceutical Technology APIs, EXCIPIENTS, AND MANUFACTURING eBOOK 2021 P h a r mTe c h . c o m Manufacturing Perhaps the anticipated increase in the develop- ment of biologic processes will result in a need to think differently about the manufacturing equip- ment employed. Traditional pharmaceutical man- ufacturing processes have typically used stainless steel equipment designed to be used many times and often with multiple actives. In the future, the absolute requirement to determine that equipment is free from any contamination may either drive the use of more dedicated equipment, or perhaps, to single-use disposable manufacturing equipment. Really understanding the raw materials going into the process is important. Fully characteriz- ing the raw materials, while also trying to submit multiple different batches of the raw materials into the process, preferably covering the range of anticipated material properties, allows for better understanding of the impact of these raw material properties on the performance of the final product. Within Vectura, the process of developing the device is not separate to the pharmaceutical de- velopment process for a medicine. Everything is progressed in a very integrated way because every change, either to the device, the formulation, the manufacturing process or even the analy tical methods used to characterize it can have a huge impact on how the device is seen to perform. It is very dangerous to look at variables in isolation when there can be such significant interactions be- tween the many different types of variables Immediate challenges in the short term revolve around speed of supply due to increased demand for device components, as well as excipients and APIs, with potential pinch-points around lead times to be overcome. In terms of device, [other] considerations relate to materials of construction or the quality of the mold tools for plastic parts. Almost anything can have the potential to impact product performance. Even the way in which com- ponents are cleaned can matter, so every aspect relating to the manufacture of components needs to be tracked and understood, even if these steps in the manufacturing process are at the supplier's sub-supplier, because the merest change has the potential to impact product performance. Vozone (Catalent): From a regulatory standpoint, inhaled combination products are a single entity that involves multi-center review by the Center for Drug Evaluation and Research, Center for Biolog- ics Evaluation and Research, and Center for De- vices and Radiological Health, and are approved via a new drug application. However, developing a combination drug–device product brings to- gether two distinct competencies that often reside in separate companies, with different develop- ment approaches. Drug development and medi- cal device experts need to cooperate closely to develop an effective and safe integrated product for patients. The design of the device is an itera- tive process framed by the intended use, patient population, and environment of use, and requires human factors studies to demonstrate a patient's ability to operate the device in a safe and effective manner. With the introduction of digital inhalers, electromechanical compatibility and the software and data integrity need to be also factored in dur- ing the development process. CDMOs play a critical role in the integration of device considerations for customers to ensure that the target product profile and product perfor- mance are adequately achieved. Early communi- cation between all parties involved is particularly important for a successful combination of both drug and device design. PT