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Downstream of downstream processing: development of recycling strategies for biopharmaceutical processes
Author(s) -
Grote Florian,
Ditz Reinhard,
Strube Jochen
Publication year - 2012
Publication title -
journal of chemical technology and biotechnology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.64
H-Index - 117
eISSN - 1097-4660
pISSN - 0268-2575
DOI - 10.1002/jctb.2727
Subject(s) - bioproduction , downstream (manufacturing) , downstream processing , bioprocess , biochemical engineering , biopharmaceutical , process (computing) , process engineering , unit operation , process development , computer science , comparability , production (economics) , risk analysis (engineering) , manufacturing engineering , engineering , microbiology and biotechnology , operations management , business , chemistry , biochemistry , mathematics , macroeconomics , combinatorics , chemical engineering , economics , biology , operating system
BACKGROUND: Downstream processing plays a crucial role in biotechnological production processes. Product concentration and purification require complex, multi‐step operations, using significant amounts of chemical and auxiliary material. Today, design and optimization is important because the process development of biotechnological products is becoming more and more expensive. It is of great importance to improve sustainable development of eco‐efficient products and processes. Integrated process and product development leads to more efficient use of raw materials. RESULTS: A new stepwise approach is proposed to develop recycling strategies for biopharmaceutical products, which can be implemented within an existing and approved process environment. This article describes the approach in detail and exemplifies the methodical procedure for characteristic reference processes. The theoretical recycling and separation tasks as well as possible strategies are defined and evaluated experimentally. An experimental model parameter determination in small scale is shown. In addition, concrete solutions are discussed due to solving regulatory constraints addressing comparability studies. CONCLUSION: It is shown that development with the aim of intensification and full integration of the individual steps of bioprocess production (modules, unit operations) leads to an improvement in every single step at the same time. It follows clearly that consistent implementation represents a meaningful contribution to next generation bioproduction design. Copyright © 2012 Society of Chemical Industry