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• W4309677669 abstract "The launch of the first wave-mixed bioreactor in the late 1990s was one of the most important milestones in single-use technology. The Wave 20 developed by Vijay Singh and Marcel Röll has given rise to numerous single-use bioreactors and devices. At their core is a replaceable, sterile plastic bag or container (the consumable), which is in contact with the cells, culture medium, intermediate or final product and is discarded after a single use. Today, it is already possible to implement complete biopharmaceutical production processes in the single-digit cubic meter range with single-use systems. Especially during upstream processing of antibody and vaccine production, single-use systems in the form of storage containers with bags, mixers, pumps, filtration systems and bioreactors for inoculum production and product expression have become indispensable. However, the application of single-use systems for downstream processing and fill – finish operations has also become increasingly popular in recent years. Modular facility concepts have emerged and intensified production processes in which single-use systems are used have progressively become the user focus. The latter even allowing for the production of equal or higher product quantities in the desired quality within a shorter period of time. Keywords here are N-1 perfusion, one-step inoculation and high-seed fed-batch production processes. Producers of single-use systems have contributed decisively to these developments by adapting their equipment more closely to customer requirements and, above all, by making it more user-friendly and safer (e.g., improved film materials to minimize the risk from leachables and extractables) to use. Work is being done on remaining limitations such as lack of single-use sensor technology. In addition, the issue of sustainability of production processes based on single-use systems is being addressed and solutions are being sought to reduce the plastic waste generated. Today, this is done in committees (e.g., DECHEMA, BPSA), amongst others, in which manufacturers as well as users from industry and academia work together. However, the biggest problem associated with the use of single-use systems at present is the timely supply of consumables to users, a direct result of the disruption of supply chains (e.g., due to the lingering Corona pandemic). On the other hand, it is a fact that without single-use technology and its characteristic agility, the Covid-19 vaccines available today could not have been developed and manufactured at the speed with which they were. To address the aforementioned supply constraints and to supply the emerging application areas (mRNA products, cell and gene therapeutics, cellular agricultural products) for single-use systems, manufacturers are expanding their production capacities. They are also preparing for the transition from gamma to X-ray radiation, which is the dominant method for sterilizing single-use devices. Thus, in new facilities, single-use technology may increasingly become the standard for the production of pre- and clinical samples, as well as commercial biotechnological products. We wish all an inspired reading of this special issue and would like to thank all authors of the articles for their work. Dieter Eibl Regine Eibl" @default.
• W4309677669 created "2022-11-29" @default.
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• W4309677669 date "2022-11-22" @default.
• W4309677669 modified "2023-10-02" @default.
• W4309677669 title "Single‐Use Technology in Biopharmaceutical Manufacture and Beyond" @default.
• W4309677669 doi "https://doi.org/10.1002/cite.202271202" @default.
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