Publication | Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing

Shukla, A., Mostafa, S., Wilson, M., Lange, D. Vertical Integration of Disposables in Biopharmaceutical Drug Substance Manufacturing, Bioprocess International, 10(6), 34-47, 2012.

Abstract
KBI Biopharma operates an end-to-end current good manufacturing practice (CGMP) manufacturing facility for biologics derived from mammalian cell culture up to the 2,000-L scale. This experience has given us a unique vantage point into disposables. Single-use (disposable) technologies are gaining significant traction in biopharmaceutical manufacturing due to reductions in capital investment for plant construction, lower requirements for cleaning and sterilization, and the advantages of eliminating cross-contamination during multi-product manufacturing. In the early days of disposables, single-use (SU) systems were used only in specific unit operations. However, recently, options have become more widely available throughout drug-substance manufacturing. Companies now focus on selecting the right SU technology from an array of options and integrating those choices into production processes.

Keywords
Disposables; Bioreactors; Chromatography; Filtration; Inoculum; Centrifugation; Storage; Freeze-thaw

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