Single-Use Products for Bioproduction: Available Options for Cell Culture and Downstream Processing

摘要

In the pharmaceutical and biotechnology industry, single-use components originated in medical practice to reduce transfer of infectious material from one patient to another. More recently, single-use products have been developed and implemented by the industry for production of biopharmaceuticals. Disposable single-use filters, buffer bags, and final bulk product storage containers gained rapid market penetration and acceptance, while single-use bioreactors for cell culture, single pass TFF systems for harvest, and disposable options for downstream processing are only recently achieving widespread use. Obstacles have included regulatory concerns, technical challenges, and an established infrastructure of stainless steel bioreactors, glass column housing, and installed CIP/SIP systems that enable reliable re-use of these production assets. Despite these obstacles, the significant advantages of