Single-use systems for biotechnology products

13 April 2017  •  Author(s): Scott Rudge, COO, RMC Pharmaceutical Solutions Inc

Single-use systems have become an important tool in the development and scale up of biotechnology processes. Single-use systems save space, increase flexibility in scale and space planning and, to a large extent, eliminate cleaning costs in development and change over. However, single-use systems come with their own challenges, including complete integration, scalability, and most of all with extractables and leachables. A comprehensive technical report has been published to guide potential new users through the process of implementing single-use technologies throughout their bioprocesses.1

Upstream processing has most fully embraced single-use technologies. From the thaw of the vial to the harvest of the bioreactor, it is possible to construct a fully disposable process stream for a cell culture process. However, limitations in heat and oxygen transfer have excluded bacterial and yeast processes. In this article, we review the available technologies and advances that have been made.

Vial thaw and cell expansion

The first steps of a cell culture biotechnology process are typically the thaw of a seed bank vial and the expansion of the cells in a series of shake flasks. In principle, these steps have always been performed in disposable containers, because the containers are small and cheap. However, there has been a change from glass shake flasks to plastic, since these are easier to transport. Since the materials are not as fragile, they can be gamma irradiated for sterilisation. This increases convenience, and increases sterility assurance, as gamma irradiation does not depend on the condensation of saturated steam in small material imperfections.

Although the materials may have changed in these steps, the footprint has not. Humidified CO2 incubator space and a sterile hood are still required. But it is possible to conduct the early stages of cell expansion without an autoclave, using all disposable, gamma-sterilised containers and implements. Eliminating the need for an autoclave also eliminates the requirement for high-quality water to produce clean steam. The utilities savings will be covered throughout this article.

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