Biologics manufacturing has seen many new developments in recent years. The industry is moving away from processing systems based on stainless steel (with cleaning and validation requirements) to single-use systems (sterilized, disposable molded plastics). As more molecules progress through Phase I and II towards commercialization, good manufacturing practices (GMP) manufacturing is also performed at larger scales than ever before. At the same time, increasing titers and the rise of personalized medicine is driving other production processes towards smaller and more individualized batch sizes. Last but not least, the COVID pandemic and the triggered vaccine race pushed single-use bioprocessing to become the industry standard. Due to these market demands, bioprocessing facilities need to increase production capabilities by becoming more modular and scalable. This demand applies to all equipment, including mixing systems, which need to adapt in order to handle a wider range of solutions and larger volumes.
This white paper presents an overview of the current mixing technology landscape driven by the need for versatile biomanufacturing platforms with increased productivity. In this context we discuss the importance of mixing as an operation and how its limitations impact biomanufacturing processes. Typical mixing requirements for a biomanufacturing facility are also presented in combination with the most recent user requirements, highlighting a quest for usability and integration improvements. Taken together, these multiple factors act as drivers for technical developments in mixing technologies, shaping the design and performance of the next generation of mixers.