Reasons for Restricting Usage
We tested 17 reasons why biopharmaceutical manufacturers and CMOs might not expand their use of disposables. Figure 3 shows the top five. The primary concern was over leachables and extractables where 75.4% of respondents agree or strongly agree that L&E issues are restricting the use of disposables. This compares with 63% of respondents last year. Part of this is the result of the increased use of disposables, which has, in turn, increased awareness and FDA interest.
The second greatest concern was the fact that participants had “already invested in equipment for current system” (65.2% agree or strongly agree). Other factors included:
becoming vendor-dependent (single-source issues)
breakage of bags and loss of production materials
investment in validation
lack of uniform standards
regulatory guidance on leachables and extractables
lack of cost data
CMOs vs. Biotherapeutic Developers
The primary reason both CMOs and biotherapeutic developers might not expand their use of disposables was concern over L&E issues (70.6% for CMOs and 75.9% for biotherapeutic developers).
When comparing differences between CMOs and biotherapeutic developers, a significantly greater number of biotherapeutic developers indicated that the primary reason they would restrict expanded use of disposables is because they have already invested in equipment for their current system (67.9% for biotherapeutic developers vs. 37.5% for CMOs). This is likely because CMOs can generally be more flexible; they can also pass many of these direct costs on to the client. Lack of lifetime operating cost data comparing stainless steel to disposable options is more of a concern to biotherapeutic developers.
Other differences between CMOs and biotherapeutic developers were found, from “lack of disposable equipment that meets process requirements” (where CMOs were more concerned), to “material incompatibility,” “lack of clear guidance on leachables and extractables,” and “breakage of bags” (where biotherapeutic developers were more concerned).
Bioreactors tend to be one of the most expensive disposable items, and they were the item on which respondents spent the most in 2007. On average, respondents spent $212,959 per facility annually on these products. This is a change from last year’s top item, which was “media bags—filled wet” on which facilities spent an average of $164,313 in 2006.