Genetic Engineering & Biotechnology News

NOV1 2018

Genetic Engineering & Biotechnology News (GEN) is the world's most widely read biotech publication. It provides the R&D community with critical information on the tools, technologies, and trends that drive the biotech industry.

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Page 52 of 57 | SEPTEMBER 1, 2018 | 15 however, the cleanroom is built with its own air handler, and if the process re- quires the addition of another fermen- ter and tank, a second cleanroom can be added easily without interrupting the existing process. The ability to scale cleanroom infra- structures without interrupting existing processes may become a priority dur- ing bioprocessing or the production of personalized medicines. When demand grows, so must the manufacturing area, the expansion of which should not conflict with existing capacities. If, however, the cleanroom infrastructure is not modular and autonomous, that is, if it lacks its own air handling sys- tem and automation, any expansion will cause major disruptions. That said, single-use technology has been and is an enabler for design- ing more flexible and confined manu- facturing areas. Process intensification and the shrinking of the manufacturing footprint have facilitated the design of cleanroom modules that can be built off site, prequalified, and moved into a shell building when ready (Figure 1). The cleanroom infrastructure build is much faster, and delivery time and cost estimates prove reliable enough to satisfy industry demands. Delivery time and cost estimates are robust be- cause off-site construction teams can work flexibly, shifting to higher pro- ductivity levels or reconfiguring sched- ules if necessary, and because modular/ podular cleanroom infrastructure units can be moved in rapidly. There are times when clients await- ing delivery of prefabricated structure request that delivery be delayed. For example, one such client, after learning that a shell building was unavailable, asked to delay its project three months. Then the client changed its mind again and asked for the original delivery date to be reinstated. With the off-site build approach, such requests can be met without additional costs. In the case just cited, the client was accommodat- ed by deploying additional resources and utilizing overtime. Instead of an on-site productivity level of typically 80%, an off-site build can run at a pro- ductivity level of 100–140%—without working in shifts. The idea that prefabricated solu- tions enable more robust planning may be developed yet further. New, predesigned, turnkey facility solutions are now being established to shorten the build time and reduce the cost im- pact by creating standardized options (Figure 2). As an example, a 4 × 2000 L mAb turnkey site can be built in 12 months versus 24–36 months at an all- in price tag of $75 million instead of $200–300 million. Transitioning one's thinking from standardized, prefabricated cleanroom units to predesigned turnkey facilities does not require a conceptual leap, only a small change in mindset to a standardized, off-the-shelf approach. Instead of spending many hours on new designs, instead of reinventing the wheel, one may proceed more simply and directly. By following the standard- ized, off-the-shelf approach, one may shorten design and build times, acquire valuable experience, and reduce costs. Conclusion Facility design requirements are evolving just as bioprocess technologies did in the transformation from stain- less steel to flexible and agile single-use process technologies. These innovative technologies have created new oppor- tunities for facilities, and modular solu- tions are clearly part of the new facility future. Facilities and processes are ap- proaching a crossroads. Processes are shifting from multiuse to single-use, and facilities are moving from single- use (product dedicated) to multiuse (multiproduct). Flexible processes lose their flex- ibility if they are forced into uncom- promising, inflexible facility and clean- room infrastructures. Total flexibility is achieved, however, when flexible pro- cesses are fused with flexible facili- ties. The cleanroom enclosures can be smaller, produced in assembly-line fashion, and completed in shorter time- frames. They can also be more readily repurposed or scaled. Some major pharmaceutical compa- nies and architecture and engineering firms have started to embrace the mod- ular cleanroom revolution, recognizing that the familiar "brick-and-mortar" and "stick-built" approaches have suc- cumbed to advances in technology. It is expected that more adopters will fol- low, leading to additional growth and collaboration in the modular space. The future holds promise for turn- key solutions that speed the design and building of biomanufacturing facilities. Such solutions allow biomanufacturers to delay capital decisions and expedite capacity gains. Traditional structures do not reduce capital expenditures and operating costs, but rather decrease the competitive advantage of the opera- tion. Single-Use Technologies for Bioprocessing Scaling cleanroom infrastructures without interrupting existing processes may become a priority during the production of personalized medicines.

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