Case Study: Introducing Disposable Systems Into Biomanufacturing

By Mark Fuller and Hélène Pora

Single-use (disposable) systems are being considered and introduced into many biopharmaceutical processes because manufacturers have identified significant benefits they offer over traditional reusable systems. These benefits are often more evident when a new process and product are being developed. Lower capital expenditures, shorter development times for new facilities, and reduced validation costs are some of the reasons single-use technology may be selected. Here, a contract manufacturer's case study is described in which an existing stainless steel system was completely replaced with a ~90% disposable manufacturing train. The specific benefits gained by this change were improved product quality, substantially reduced processing times, and lower operating costs.

Changing an existing reusable system to a disposable system may not always seem attractive. In a recent survey of manufacturers, 65% of respondents stated that investment in existing equipment restricted their implementation of disposables. However, the data also showed that contract manufacturing organizations (CMOs) were less restricted by legacy systems, indicating that other factors can contribute significantly to a justification for disposables by CMOs .

In many processes, assessment of the possible replacement of existing stainless steel systems with disposable components may be a worthwhile exercise because it can often realize specific and sometimes unexpected benefits. For example, the survey listed some critical reasons identified by manufacturers for increasing their use of disposables.

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