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.