Process Development EconomyThe greatly reduced production suit footprint required by SUBs and SUMs reduces facility design, construction and consequent costs (Fig. 2). Savings also come from reduced service requirements, such as the severely reduced (and sometimes eliminated) requirement for regulated water or steam, due to the elimination of CIP and SIP systems. Manufacturing modeling programs reveal that total manufacturing costs using SUS can be significantly less than that from conventional systems. Because of the reduced capitalized cost of the smaller facilities and equipment with SUS, initial charges are dramatically reduced. Also, costs from the disposable elements of the SUS are deferred to the time of use, converting fixed to variable costs. When increasing production, SUS provide an easy and inexpensive “scaling out” of capacity.
Process Development EfficiencyThe utility of SUTs have been demonstrated for all major animal cell-lines and production modes, from CHO to insect cells, in fed-batch or perfusion production modes. This allows employing the precise format determined to yield the most efficient production. Because they do not require CIP and SIP, SUS accelerate facility design and construction schedules. Reduced facility requirements can even allow installation in existing suits– saving many months of time. Decreased or eliminated services also greatly shorten the time spent in facility, equipment and process qualification and validations. The reusable non-product contact hardware for such systems as single use mixers (SUMs) and single use bioreactors (SUBs) can be constructed and installed in a matter of weeks, remarkably reducing equipment design and build times. The remarkable scalability of some SUS equipment is a great advantage in PD and technical transfer (Fig. 3). The efficiency of custom designed, multiply overwrapped, freezable and pre-sterilized flexible bioprocess containers (BPCs) eases GMP cold chain and good storage practice procedure establishment and validation. There are a quite a number of “flexibilities” provided by SUTs that can rather spectacularly reduce process development time. Many SUSs support flexibility in the designation of integral components. From operating systems to connectors the client is able to select the particular components and vendors desired– reducing cost and time in component qualification. Component and flowpath specifications are easily altered after initial design, supporting easy and rapid response to updates in equipment, components, or flow. Development runs can be accelerated because of the reduced turnaround time with SUBs and SUMs (often a matter of hours). Many SUS skids can be easily re-located, even wheeled, to new locations within plant, opening doors of opportunity and shortening PD time. Finally, SUS support the employment of divergent raw material and products types and classification, accelerating the design of trial runs. So we are currently seeing a revolution in bioprocessing with the uncharacteristically rapid adoption of single-use materials throughout the production train. But what’s even more exciting are the newer SUT and products in the pipeline supporting such intriguing prospects as completely closed and continuous manufacturing. To learn more about large scale bioprocessing solutions in an easy and fun format, you may visit www.youtube.com/bioprocessing Figure 1 . SUS offerings profide choices to various sponsors needs.
|1A A “turnkey” single-use bioreactor providing maximum speed and convenience of establishing de novo bioproduction capability. (Courtesy Thermo Fisher Scientific)|
|1B An “open-architecture” single-use bioreactor providing maximum SUT flexibility and economy. (Courtesy Thermo Fisher Scientific)|
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