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.

Issue link:

Contents of this Issue


Page 50 of 57 | SEPTEMBER 1, 2018 | 13 Single-Use Technologies for Bioprocessing Maik W. Jornitz The pharmaceutical and biopharmaceutical industry needs to execute a shift from large- volume, single-product processes to small-vol- ume, multiproduct processes. The shift is not restricted to development-stage activities. It extends to commercial-stage operations. Flex- ibility in accomplishing the shift will help bio- manufacturers hit capacity targets, optimize facility utilization, and stay competitive. With higher expression rates, cell cul- ture processes that used to require 10,000– 20,000-L bioreactors can now move to lower volumes. Smaller volumes permit the use of single-use technologies, as the maximum vol- ume applicable to single-use bioreactor tech- nologies is around 2000 L. Large-scale, stainless-steel systems carry inherent risks. For example, large systems may be difficult to set up and clean, and they may cause facilities to become dedicated to only one product. Also, if these systems be- come contaminated, large bioreactor vol- umes are lost. These risks can be reduced if multiple small-volume systems are installed. Smaller volumes may be processed more simply with the benefit of single-use components or unit operations. And if contamination occurs, it is possible to limit product and therefore fi- nancial losses. Not too long ago, single-use equipment components within the pharmaceutical and biopharmaceutical industry were admired for their novelty and innovation but still viewed with skepticism. Nowadays, single-use equip- ment is widely utilized and an integral part of upstream and downstream processing. Furthermore, the focus of single-use tech- nology utilization is shifting from biophar- maceutical processes to aseptic processing streams in cell and gene therapies. Anywhere containment is a priority—inside a process, where product needs to be protected, or outside the facility, where the environment must be guarded—single-use technology is the process technology of choice. In addition, there is an urge to enhance flexibility, shorten batch cycle times, avoid cleaning validations, and reduce utility costs. Uses of Single-Use Process Technology Single-use technology vendors are numer- ous and diverse, delivering processes, unit op- erations, or specifically focused components, giving end-users a multitude of options for supplies and equipment. Options range from simple bags to bag/filter/tubing/valve/aseptic connector assemblies to entire unit opera- tions, whether for cell culture or virus inacti- vation, to just name two processes. Through their engineering and design functions, single-use process technology ven- dors are defining processing platforms for Single-Use Technology Underpins Modular Cleanrooms A Prefab Design-and-Build Approach, Says G-CON, Means Speed, Flexibility, and Economy Figure 1. Podular cleanroom cluster (14 PODs built in eight months, installed in three days) Maik W. Jornitz is president and CEO of G-CON Manufacturing. Website:

Articles in this issue

Links on this page

Archives of this issue

view archives of Genetic Engineering & Biotechnology News - NOV1 2018