Manufacturers of Biologics to Increasingly Use Single-Use Technologies
Posted on: Thursday, July 16, 2015

Biologics manufacturing facilities using traditional stainless-steel bioreactors have to deal with significant manufacturing suite unavailability between production cycles due to expensive cleaning technology, extensive cleaning validation, and the associated loss of productivity and revenue. The use of single-use and disposal technologies such as single-use bioreactors (SUB) can greatly increase the production efficiency by reducing the need for the same. The single-use and disposal technology has been used for decades in the research and development setting where biological cultures routinely use disposable culture ware, pipettes, storage bottles and small-scale bioreactors. However, its use in large-scale commercial manufacture of biologics is relatively new. Data has been available only since 2012 for this technology in commercial manufacturing and the trends show increased use in recent years. It is being projected that in the next 5 years, the use of single-use technology will triple in the US and more than double world-wide with the increase availability of this technology and acceptance by the regulators. The technology has its supporters not in the industry but also regulators who believe such technology reduces the overall risk of contamination and provides higher control of manufacturing. The technology has also found supporters in public policy due to the less environmental hazards and recyclable nature of the plastics used in the single-use technology without the use of hundreds of thousands gallons of water needed for clean-in-place and steam-in-place processes for stainless steel reactors.   

Expert Opinion: Mukesh Kumar
VP, RA, Amarex Clinical Research