Single-Use, Stirred-Tank Bioreactors: Efficient Tools for Process Development and Characterization

摘要

During the past decade; single-use bioreactors have become widely accepted as an alternative to conventional stainless steel or glass bioreactors for clinical manufacturing and process development. In the biopharmaceutical industry, glass bioreactorsare used mainly for process development and optimization, but also scale-down models for process characterization. So it is of significant importance that such vessels replicate the design of production-scale bioreactors for both reusable and single-useapplications. Stirred-tank bioreactors with 2-L, 5-L, and 10-L working volumes have proven to be particularly well adopted across the industry. The 2-L version is the work horse of process development, with a volume sufficiently large to serve as a representative small-scale model that allows sampling, yet is easy to handle.