Contract manufacturing organisation Rentschler Biotechnologie will add a 2,000-litre single-use bioreactor to be fully operational end of the first quarter of 2015 to its facility in Laupheim, Germany, to match the growing demands for production capacity for all clinical phases.
Single-use technologies have gained broad acceptance in biomanufacturing within the past few years, supporting flexible and cost-effective clinical production. Beyond this, the first manufacturing processes for market products using disposable equipment (Shire, Protalis) have already been approved by European and US authorities. Currently, two thirds of all new bioprocesses are carried out in single-use equipment. Thousand-litre single-use bioreactors (SUBs) represent the common standard, although 2,000L SUBs are on the advance. In general, an optimistic growth market in the double-digit range is predicted.1
Compared with bioreactors made of stainless steel, single-use production plants not only have a low contamination risk, but are also more cost-effective and faster to implement. The initial investment costs are approximately 40% lower, and since systems for cleaning and sterilisation (CIP/SIP) are obsolete and time-consuming pipework is not required, the project lead-time for implementation of single-use production plants is reduced by at least eight months compared with stainless steel reactors, which still have their place in commercial production.
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