White paper on continuous bioprocessing. May 20-21, 2014 Continuous Manufacturing Symposium

• Published in: Journal of pharmaceutical sciences Vol. 104; no. 3; p. 813
• Main Authors: Konstantinov, Konstantin B, Cooney, Charles L
• Format: Journal Article
• Language: English
• Published: United States 01-03-2015
• Subjects: Biological Products - chemistry; Biological Products - standards; Bioreactors; Cell Culture Techniques; Cells, Cultured; Drug Industry - instrumentation; Drug Industry - methods; Drug Industry - standards; Drug Industry - trends; Humans; Organizational Culture; Pharmaceutical Preparations - chemistry; Pharmaceutical Preparations - standards; Quality Control; Systems Integration; Technology, Pharmaceutical - instrumentation; Technology, Pharmaceutical - methods; Technology, Pharmaceutical - standards; Technology, Pharmaceutical - trends; Workflow; biotechnology; continuous bioprocessing; regulatory science; cell culture; separation science; chromatography; integrated continuous biomanufacturing; perfusion cell culture; continuous purification
• ISSN: 1520-6017
• DOI: 10.1002/jps.24268

There is a growing interest in realizing the benefits of continuous processing in biologics manufacturing, which is reflected by the significant number of industrial and academic researchers who are actively involved in the development of continuous bioprocessing systems. These efforts are further encouraged by guidance expressed in recent US FDA conference presentations. The advantages of continuous manufacturing include sustained operation with consistent product quality, reduced equipment size, high-volumetric productivity, streamlined process flow, low-process cycle times, and reduced capital and operating cost. This technology, however, poses challenges, which need to be addressed before routine implementation is considered. This paper, which is based on the available literature and input from a large number of reviewers, is intended to provide a consensus of the opportunities, technical needs, and strategic directions for continuous bioprocessing. The discussion is supported by several examples illustrating various architectures of continuous bioprocessing systems.