Concepts for Disposables in Biopharmaceutical Manufacture

Abstract

The biopharmaceutical manufacturing industry has had a long relationship with stainless steel, and even a decade ago it would have been hard to imagine the industry embracing a new concept that could make stainless steel redundant. Even so, the tide is turning, and disposable concepts are on the rise (Sinclair and Monge 2004). Disposable equipment became popular for upstream production in the 1990s, with the advent of “single-use” media bags and bioreactors, and the use of disposable capsules for sterile filtration (Meyeroltmanns et al. 2005). Over the next few years, disposable concepts also began to appear in downstream processing. Initially, this was restricted to buffer bags and devices for normal flow filtration, including virus filtration and guard filters for chromatographic columns, but gradually more complex concepts have been introduced, including disposable devices for tangential flow filtration and chromatography (Walter 1998; Ransohoff 2004; Gottschalk 2006). The current importance of disposable concepts in downstream processing was demonstrated in a recent industry survey, in which 37% of respondents considered cost-effective disposables to be important for addressing downstream process capacity issues in 2006, when compared to 24% in 2005 (BioPlan BioProcess Technology Consultants 2005, 2006).