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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14 | SEPTEMBER 1, 2018 | GENengnews.com specific applications and rapidly de- ploying new processes when required. They are also providing scalability, with cell culture expanding to volumes as large as 2000 L, or shrinking, poten- tially, to volumes of 200–500 L, given the rapid evolution to continuous bio- processing. In single-use systems, the critical fluid path may be protected within a cleanroom area. Outside this area, me- dia and buffer supplies may be held un- til they are needed. Then, they may be fed through ports to the point of use. With single-use process technology, specific cleaning and sterilization ar- eas are unnecessary, so process designs show much smaller footprints. Water use is drastically reduced, which means that utility spaces can be condensed. Essentially, single-use process technol- ogy enables process intensification— allowing cleanroom infrastructures and entire facility layouts to become smaller. Furthermore, single-use process technology creates solid containment options to protect the processed drug product, to utilize a facility as a multi- product process, and to safeguard the personnel and environment of the fa- cility. The containment requirement is becoming a focus with new therapies being introduced within the cell and gene therapy sector. Fluid streams within these applica- tions often cannot be finally sterilized, and therefore the entire process must be safeguarded by appropriate con- tainment options, one of them being single-use process equipment. Fluid volumes within the cell therapy area are very small (batches being patient based), and contaminations would be detrimental. From needle to needle, the technologies used to process patient samples must not only support flex- ibility but also provide robust contain- ment. Single-use process technology is also changing cleanroom classifications. For example, new bioprocess facilities are designed into ballroom infrastructures, which are run at ISO 9 classification. The single-use process technology in this case is regarded as a closed system, which allows the reduced cleanroom rating. From Single-Use Process Technologies to Modular Facilities Because facilities and processes are distinctly different, they must be designed and constructed in different ways. A facility is not necessarily flex- ible just because the process employs single-use technology. The opposite is often true. Traditional facility layouts may void the flexibility of single-use processes, since these processes are of- ten mobile. If the layout of the facility does not allow easy access or movement, the benefits of flexible process equip- ment are squandered. For example, if a cleanroom space is built to house one fermenter and one tank with no allow- ance for other equipment or additional personnel, and the required cleanroom ductwork is interconnected into the cleanroom from the larger facility area, a change as small as the addition of a second fermenter or tank could result in having to rebuild the entire room. If, Single-Use Technologies for Bioprocessing Single-Use Technology Underpins Modular Cleanrooms Continued from page 13 Figure 2. Predesigned, turnkey facility solution for multiple scales of mAb production (iCON ™ )

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