Cell-based biologics are difficult to further purify post-manufacture. It is therefore imperative to limit the amount of particulate matter introduced during production. Indeed, non-microbial particulates were the cause for numerous US FDA recalls over the last two decades. Better equipment is one way to limit particulate matter during manufacturing, as equipment accounts for an estimated 15 percent of particle generation within a clean room.
Download this application note from Thermo Fisher Scientific to learn more about their clean room-compatible CO2 incubators and how they significantly reduce clean room particle emissions during normal operation.
