Bridging the Gap from Reusable to Single-Use Manufacturing with Stirred, Single-Use Bioreactors A Development Approach Based on the Gold Standard

During the past few years, use of disposable bioreactors in development and manufacturing processes has become widely accepted. Particularly, low–oxygen-demanding cell types such as human and insect cells have proven to be perfectly suitable for cultivation in single-use bag chambers. These bioreactors have significant advantages over their reusable counterparts (1). They transform a single-purpose process using stainless steel reactors into a multipurpose facility in which switching from one application to another is both easy and cost effective. Reusable stainless steel bioreactors have fixed vessel configurations with predefined port assemblies, whereas single-use bioreactors use presterilized plastic cultivation chambers that get discarded after use. That makes adapting such cultivation vessels to specific applications highly convenient. Because single-use bags are presterilized by their suppliers, sterilization/cleaning is not required. That eliminates spaceconsuming and expensive clean-inplace (CIP) and steam-in-place (SIP) installations while reducing production turnaround times. With associated efforts for validation reduced, this ultimately shortens time to market and provides a faster return on investment.