Stage of Production/Application
Expectedly, disposables in 2007 were found to be used mainly during scale-up/clinical production. Some of the key data included the use of sampling systems, which were used by over 50% of respondents in their commercial-scale production.
Bioreactors are now used by 27.5% of respondents in some way in their commercial-scale production. Faster growth for clinical-stage manufacturing was expected because in commercial stages it is more difficult and costly to switch due to regulatory considerations. However, sampling systems are some of the easiest to implement and are relatively easy to switch.
Newly Introduced Applications
We evaluated 12 newly introduced or implemented disposable applications. From the survey, 47.5% of respondents said the use of disposables for buffer storage was newly introduced or implemented at their facility during the previous 12 months.
Other disposables that have been newly introduced were buffer prep (by 40.3% of respondents), filtration (39.6%), and media storage (33.1%). Both solution preparation and storage involve the same functional area. Thus, if a decision was made to store buffers in plastic, it may be a logical step to also make them in plastic.
Leachables and Extractables
Respondents were asked a number of questions regarding leachables and extractables (L&E) in disposables. We found that 74.3% agreed or strongly agreed that, “vendor should generate L&E data and validate the data.” That number, however, declined in relation to later stage manufacturing, where 41.1% said they “expect to generate L&E data myself for Phase III or commercial applications.”
This likely reflects biomanufacturers’ need to reduce regulatory risks associated with leachables and extractables at later stages of production. Even at late-stage clinical production and commercial production, more than half of biomanufacturers expect vendors to be generating data on leachables and extractables. Significantly, nearly a third also indicated they would pay 25% more for their disposables if they were provided such data.