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Dinos reborn7/3/2023 ![]() At 2 m 3 in size, a 2,000-L vessel is difficult to fit down passageways, has significant momentum, and takes up considerable space.Īnother factor is the potential market size for these “super-sized” bags. Very few products are available for larger scales than this ( 2), mainly because of physical considerations: Full bags at or above the 2,000-L level are not self-supporting and are inherently unable to be transported without jack lifts ( 7). Many studies cite 2,000 L as the largest efficient size for current single-use vessels. Vessel Scale: The scale or sizing of a vessel under consideration is the first element in determining whether disposables are a suitable alternative to stainless steel. The need to integrate them with existing conventional stainless steel systems requires setting priorities of key facility areas where disposables may provide benefit and can be implemented with minimal disruption. In such cases, the benefits of retrofitting for disposables become less clear. WFI in facilities with already purchased (and partially depreciated) stills is also relatively inexpensive, at $0.05–0.20 per liter. However, many facilities already have this support infrastructure in place, with highly evolved systems to reduce associated labor. However, looking at the feasibility of incorporating disposables technologies requires a more comprehensive analysis of the benefits of disposables than arguments presented for “green-fields” facilities.Ĭlassic arguments for disposables highlight the reduced need for clean-in-place and steam-in-place systems, lower water for injection (WFI) use, and lower validation and qualification times ( 4, 5, 6). In many cases, retrofitting existing plants to handle high-titer processes can be done inexpensively and in short timeframes. Even new facilities built in this period are likely to include stainless steel for production bioreactors and in much of the downstream purification train due to both technological issues and the risk adversity of the industry.īecause of ongoing improvements in titer and other plant operations, there is a growing excess of large-scale cell culture capacity and a need to understand how it is manifested in a specific plant setting. Many processes will be conducted in primarily stainless steel plants, which are already in operation or near completion. During the next 5–10 years, titers for new clinical and commercial processes will average >4 g/L, and some may reach 20 g/L ( 3). One issue arising from the current capacity abundance of stainless-steel units is identification of areas where disposables may benefit existing facilities. Figure 1 summarizes these data, showing the level of disposables adoption in existing large-scale facilities based on a cross-sectional survey of use across biomanufacturers.įeasibility of Retrofitting Biomanufacturing Facilities We do not seek to outline particular technologies available from vendors good summaries are available ( 1, 2). Single-use technologies have evolved quickly during the past decade, morphing from relatively simple bag-based solutions to increasingly sophisticated bioreactor and purification-based technologies. ![]() KEYWORDS: BIOREACTORS, SCALE-UP, BUFFER PREPARATION, FACILITY DESIGN AND ENGINEERING, LEACHABLES, EXTRACTABLES WHO SHOULD READ: PROCESS DEVELOPMENT, MANUFACTURING, QA/QC, OPERATIONS AND FACILITIES MANAGERS We instead look at such technologies in terms of their ability to reduce complexity in facility design and allow greatest flexibility in making changes to process design. My firm’s research suggests that in a retrofit setting, disposables have little proven value for reducing installation, materials, or labor costs. I advocate a systematic approach to look holistically at possible retrofit technologies in existing (stainless steel) facilities, with particular reference to disposables. Some experts have gone so far as to suggest that large-scale stainless steel fermentors are “dinosaurs,” with their large capacities, long installation lead times, and low flexibility. ![]() Although a number of biomanufacturers have adopted disposable technologies for small-scale process design, there has been considerable debate over the role of single-use systems in large-scale biopharmaceutical manufacturing- particularly in retrofitting facilities.
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