Ou Yang1, Maen Qadan2, Marianthi Ierapetritou1. 1. Department of Chemical and Biochemical Engineering, Rutgers-The State University of New Jersey, 98 Brett Road, Piscataway, New Jersey 08854-8058, United States. 2. Eli Lilly and Company, Lilly Corporate Center, Indianapolis, IN 46285, United States.
Abstract
PURPOSE: There is a growing interest in continuous biopharmaceutical processing due to the advantages of small footprint, increased productivity, consistent product quality, high process flexibility and robustness, facility cost-effectiveness, and reduced capital and operating cost. To support the decision making of biopharmaceutical manufacturing, comparisons between conventional batch and continuous processing are provided. METHODS: Various process unit operations in different operating modes are summarized. Software implementation, as well as computational methods used, are analyzed pointing to the advantages and disadvantages that have been highlighted in the literature. Economic analysis methods and their applications in different parts of the processes are also discussed with examples from publications in the last decade. RESULTS: The results of the comparison between batch and continuous process operation alternatives are discussed. Possible improvements in process design and analysis are recommended. The methods used here do not reflect Lilly's cost structures or economic evaluation methods. CONCLUSION: This paper provides a review of the work that has been published in the literature on computational process design and economic analysis methods on continuous biopharmaceutical antibody production and its comparison with a conventional batch process.
PURPOSE: There is a growing interest in continuous biopharmaceutical processing due to the advantages of small footprint, increased productivity, consistent product quality, high process flexibility and robustness, facility cost-effectiveness, and reduced capital and operating cost. To support the decision making of biopharmaceutical manufacturing, comparisons between conventional batch and continuous processing are provided. METHODS: Various process unit operations in different operating modes are summarized. Software implementation, as well as computational methods used, are analyzed pointing to the advantages and disadvantages that have been highlighted in the literature. Economic analysis methods and their applications in different parts of the processes are also discussed with examples from publications in the last decade. RESULTS: The results of the comparison between batch and continuous process operation alternatives are discussed. Possible improvements in process design and analysis are recommended. The methods used here do not reflect Lilly's cost structures or economic evaluation methods. CONCLUSION: This paper provides a review of the work that has been published in the literature on computational process design and economic analysis methods on continuous biopharmaceutical antibody production and its comparison with a conventional batch process.
Authors: John Erickson; Jeffrey Baker; Shawn Barrett; Ciaran Brady; Mark Brower; Ruben Carbonell; Tim Charlebois; Jon Coffman; Lisa Connell-Crowley; Michael Coolbaugh; Eric Fallon; Eric Garr; Christopher Gillespie; Roger Hart; Allison Haug; Gregg Nyberg; Michael Phillips; David Pollard; Maen Qadan; Irina Ramos; Kelley Rogers; Gene Schaefer; Jason Walther; Kelvin Lee Journal: Biotechnol Bioeng Date: 2021-02-02 Impact factor: 4.530