Increasing expression rates in mammalian cell culture processes and the rapid implementation of single-use process technologies, encourage the biopharmaceutical industry to evaluate smaller footprint cleanroom infrastructures, respectively facility designs. The need for these smaller, but more flexible, manufacturing facility designs were accelerated by the requirement to establish in-country/for country manufacturing and by biosimilar developments, which require multi-product processing capabilities. Furthermore, therapies are changing and highly potent components necessitate robust containment and cell therapies the protection of the purely aseptic process. The call for higher flexibility and agility, besides rapid deployment and shorter time to run, generated a favorable view and adoption of innovations within the manufacturing area designs and cleanroom infrastructures. Traditional systems are getting replaced by more flexible and robust design and material options. Modular biomanufacturing facilities are adopted to gain the required flexibility and shorter time-to-run. To the benefit of the industry though, modular designs and materials evolve further, creating an enhanced toolbox of facility design choices. The evolution is not stopping at the materials and construction of the modular cleanroom infrastructures, but enhance further to standardized or platform systems, which can also reduce design timelines in future. Ultimately, at least common manufacturing processes should become a catalogue item to pick and chose from, to redline it and abbreviated the hours and hours spent to create the same anew.
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Original Publication Date: 01/2017