Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities

Reference

1. 1.↵
   1. Levine H. L.,
   2. Lilja J. E.,
   3. Stock R.,
   4. Hummel H.,
   5. Jones S. D.

   Efficient, Flexible Facilities for the 21st Century, BioProcess International 2012, 10 (11), 20–30.

   OpenUrl
2. 2.↵
   1. Walsh G.

   Biopharmaceutical Benchmarks 2014. Nature Biotechnol. 2014, 32 (10), 992–1000.

   OpenUrlCrossRefPubMed
3. 3.↵
   1. Farid S. S.,
   2. Pollock J.,
   3. Ho S. V.,
   4. Subramanian G.

   Evaluating the Economic and Operational Feasibility of Continuous Processes for Monoclonal Antibodies. Continuous Processing in Pharmaceutical Manufacturing; Wiley-VCH Verlag GmbH & Co. KGaA: Weinheim, Germany, 2014; pp 433–456.
4. 4.↵
   1. Kelley B.

   Industrialization of mAb Production Technology: The Bioprocessing Industry at a Crossroads. mAbs 2009, 1 (5), 443–452.

   OpenUrlCrossRefPubMedWeb of Science
5. 5.↵
   1. Croughan M. S.,
   2. Konstantinov K. B,
   3. Cooney C.

   The Future of Industrial Bioprocessing: Batch or Continuous. Biotechnol. Bioeng. 2015, 112 (4), 648–651.

   OpenUrl
6. 6.↵
   1. Klutz S.,
   2. Magnus J.,
   3. Lobedann M.,
   4. Schwan P.,
   5. Maiser B.,
   6. Niklas J.,
   7. Temming M.,
   8. Schembecker G.

   Developing the biofacility of the future based on continuous processing and single-use technology. J. Biotechnol. 2015, 213, 120–130.

   OpenUrl
7. 7.↵
   1. Xenopoulos A.

   A New, Integrated, Continuous Purification Process Template for Monoclonal Antibodies: Process Modeling and Cost of Goods Studies. J. Biotechnol. 2015, 213, 42–53.

   OpenUrl
8. 8.↵
   1. Adachi K.,
   2. Nishijima Y.

   Continuous Process for Producing Refined Sugar, U.S. Patent 3,781,174, December 25, 1973.
9. 9.↵
   1. Cole E.,
   2. Howard H.

   Continuous Process for Separating Oily Sludges, U.S. Patent 3,696,021, October 3, 1972.
10. 10.↵
    1. Roger Dille D. M.,
    2. McEachern R.

    Continuous Process for the Air Oxidation of Sour Water. U.S. Patent 3,761,409, September 25, 1973.
11. 11.↵
    1. Clincke M.-F.,
    2. Mölleryd C.,
    3. Samani P. K.,
    4. Lindskog E.,
    5. Fäldt E.,
    6. Walsh K.,
    7. Chotteau V.

    Very High Density of Chinese Hamster Ovary Cells in Perfusion by Alternating Tangential Flow or Tangential Flow Filtration in Wave Bioreactor^TM—Part II: Applications for Antibody Production and Cryopreservation. Biotechnol. Prog. 2013, 29 (3) 768–777.

    OpenUrl
12. 12.↵
    1. Anicetti V.

    Biopharmaceutical Processes: A Glance into the 21st Century. BioProcess International 2009, 7 (4).
13. 13.↵
    1. Vogel J. H.,
    2. Nguyen H.,
    3. Giovannini R.,
    4. Ignowski J.,
    5. Garger S.,
    6. Salgotra A.,
    7. Tom J.

    A New Large-Scale Manufacturing Platform for Complex Biopharmaceuticals. Biotechnol. Bioeng. 2012, 109 (12), 3049–3058.

    OpenUrlPubMed
14. 14.↵
    1. Pollock J.,
    2. Ho S. V.,
    3. Farid S. S.

    Fed-batch and perfusion culture processes: Economic, environmental, and operational feasibility under uncertainty, Biotechnol. Bioeng. 2013, 110 (1), 206–219.

    OpenUrlPubMed
15. 15.↵
    1. Konstantinov K. B.,
    2. Cooney C. L.

    White Paper on Continuous Bioprocessing. J. Pharm. Sci. 2015, 104 (3), 813–820.

    OpenUrl
16. 16.↵
    1. Warikoo V.,
    2. Godawat R.,
    3. Brower K.,
    4. Jain S.,
    5. Cummings D.,
    6. Simons E.,
    7. Johnson T.,
    8. Walther J.,
    9. Yu M.,
    10. Wright B.,
    11. McLarty J.,
    12. Karey K. P.,
    13. Hwang C.,
    14. Zhou W.,
    15. Riske F.,
    16. Konstantinov K.

    Integrated Continuous Production of Recombinant Therapeutic Proteins. Biotechnol. Bioeng. 2012, 109 (12) 3018–3029.

    OpenUrlPubMed
17. 17.↵
    1. Godawat R.,
    2. Konstantinov K.,
    3. Rohani M.,
    4. Warikoo V.

    End-to-End Integrated Fully Continuous Production of Recombinant Monoclonal Antibodies. J. Biotechnol. 2015, 213, 13–19.

    OpenUrl
18. 18.↵
    1. Chon G. J.,
    2. Zarbis-Papastoitsis H.

    Advances in the Production and Downstream Processing of Antibodies. New Biotechnol. 2011, 28 (5), 458–463.

    OpenUrl
19. 19.↵
    1. Hernandez R.

    Continuous Manufacturing: A Changing Processing Paradigm. BioPharm International 2015, 28 (4), 20–26.

    OpenUrl
20. 20.↵
    1. Jagschies G.

    Where Is Biopharmaceutical Manufacturing Heading? BioPharm International 2008, 21 (10), 72–88.

    OpenUrl
21. 21.↵
    1. Walther J.,
    2. Godawat R.,
    3. Hwang C.,
    4. Abe Y.,
    5. Sinclair A.,
    6. Konstantinov K.

    The Business Impact of an Integrated Continuous Biomanufacturing Platform for Recombinant Protein Production. J. Biotechnol. 2015, 213, 3–12.

    OpenUrl
22. 22.↵
    1. Lakhdar K.,
    2. Zhou Y.,
    3. Savery J.,
    4. Titchener-Hooker N. J.,
    5. Papageorgiou L. G.

    Medium Term Planning of Biopharmaceutical Manufacture Using Mathematical Programming. Biotechnol. Prog. 2005, 21 (5), 1478–1489.

    OpenUrlPubMed
23. 23.↵
    1. Siganporia C. C.,
    2. Ghosh S.,
    3. Daszkowski T.,
    4. Papageorgiou L. G.,
    5. Farid S. S.

    Capacity Planning for Batch and Perfusion Bioprocesses across Multiple Biopharmaceutical Facilities. Biotechnol. Prog. 2014, 30 (3), 594–606.

    OpenUrl
24. 24.↵
    1. Patil R.,
    2. Godawat R.,
    3. Vetter T.,
    4. Waghmare Y.,
    5. Konstantinov K.,
    6. Warikoo V.

    Development of Functionally Closed Downstream Operations for Continuous Biomanufacturing of Recombinant Therapeutic Proteins. Integrated Continuous Biomanufacturing II, November 1–5, 2015.
25. 25.↵
    1. Walther J.,
    2. Shah N.,
    3. Hollenbach M.,
    4. Wang J.,
    5. Yu M.,
    6. Lu J.,
    7. Yang Y.,
    8. Villiger A.,
    9. Konstantinov K.,
    10. Hwang C.

    Delivering Steady-state Product Quality with an Intensified and Integrated Perfusion Cell Culture Process. Integrated Continuous Biomanufacturing II, November 1–5, 2015.
26. 26.↵
    1. Walther J.,
    2. Shah N.,
    3. Hollenbach M.,
    4. Wang J.,
    5. Yu M.,
    6. Lu J.,
    7. Yang Y.,
    8. Konstantinov K.,
    9. Hwang C.

    Overcoming Process Intensification Challenges To Deliver a Manufacturable and Competitive Integrated Continuous Biomanufacturing Platform. Cell Culture Engineering XV, May 8–13, 2016.
27. 27.↵
    1. Koulouris A.,
    2. Calandranis J.,
    3. Petrides D. P.

    Throughput Analysis and Debottlenecking of Integrated Batch Chemical Processes. Computers & Chemical Engineering 2000, 24 (2), 1387–1394.

    OpenUrl
28. 28.↵
    1. Litzen D. B.,
    2. Bravo J. L.

    Uncover Low-cost Debottlenecking Opportunities. Chem. Eng. Prog. 1999, 95 (3), 25.

    OpenUrl
29. 29.↵
    1. Kondili E.,
    2. Pantelides C.,
    3. Sargent R.

    A General Algorithm for Short-term Scheduling of Batch Operations—I. MILP Formulation. Computers & Chemical Engineering 1993, 17 (2) 211–227.

    OpenUrl
30. 30.↵
    1. Toumi A.,
    2. Jurgens C.,
    3. Jungo C.,
    4. Maier B.,
    5. Papavasileiou V.,
    6. Petrides D.

    Design and Optimization of a Large Scale Biopharmaceutical Facility Using Process Simulation and Scheduling Tools. Pharm. Eng. 2010, 30 (2), 1–9.

    OpenUrl
31. 31.↵
    1. Witchey-Lakshmanan L.,
    2. Aranha H.

    How Project Management Fits into the Drug Development Continuum. BioProcess International 2010, May 1. http://www.bioprocessintl.com/business/economics/how-project-management-fits-into-the-drug-development-continuum-279360/
32. 32.↵
    1. Team R. C.

    R: A Language and Environment for Statistical Computing. R Foundation for Statistical Computing, Vienna, Austria, ISBN 3-900051-07-0, 2013; 2014. http://www.R-project.org/
33. 33.↵
    1. Gurobi I.

    Optimization, Gurobi Optimizer Reference Manual, 2015. http://www.gurobi.com
34. 34.↵
    1. Bisschops M.,
    2. Frick L.,
    3. Fulton S.,
    4. Ransohoff T.

    Single-use, Continuous-countercurrent, Multicolumn Chromatography, BioProcess International 2009, 7 (6) S18–S23.

    OpenUrl
35. 35.↵
    1. Shinkazh O.,
    2. Kanani D.,
    3. Barth M.,
    4. Long M.,
    5. Hussain D.,
    6. Zydney A. L.

    Countercurrent Tangential Chromatography for Large-scale Protein Purification. Biotechnol. Bioeng. 2011, 108 (3), 582–591.

    OpenUrlPubMed
36. 36.↵
    1. Holzer M.,
    2. Osuna-Sanchez H.,
    3. David L.

    Multicolumn Chromatography. BioProcess International 2008, 6 (8), 74–84.

    OpenUrl
37. 37.↵
    1. Bonham-Carter J.,
    2. Shevitz J.

    A Brief History of Perfusion Biomanufacturing. BioProcess International 2011, 9 (9), 24–30.

    OpenUrl
38. 38.↵
    1. Shukla A. A.,
    2. Thömmes J.

    Recent Advances in Large-scale Production of Monoclonal Antibodies and Related Proteins. Trends Biotechnol. 2010, 28 (5) 253–261.

    OpenUrlCrossRefPubMed
39. 39.↵
    1. Pollock J.,
    2. Bolton G.,
    3. Coffman J.,
    4. Ho S. V.,
    5. Bracewell D. G.,
    6. Farid S. S.

    Optimising the Design and Operation of Semi-continuous Affinity Chromatography for Clinical and Commercial Manufacture. J. Chromatogr., A 2013, 1284, 17–27.

    OpenUrl
40. 40.↵
    1. Petrides D.

    Bioprocess Design and Economics; Oxford University Press: Oxford, UK, 2000.
41. 41.↵
    1. Petrides D.,
    2. Carmichael D.,
    3. Siletti C.,
    4. Koulouris A.

    Biopharmaceutical Process Optimization with Simulation and Scheduling Tools. Bioengineering 2014, 1 (4), 154–187.

    OpenUrl
42. 42.↵
    1. Shukla A. A.,
    2. Hubbard B.,
    3. Tressel T.,
    4. Guhan S.,
    5. Low D.

    Downstream Processing of Monoclonal Antibodies—Application of Platform Approaches. J. Chromatogr, B 2007, 848 (1), 28–39.

    OpenUrlCrossRef
43. 43.↵
    1. Koulouris A.,
    2. Siletti C. A.,
    3. Petrides D. P.

    Scheduling Challenges in Biopharmaceutical Manufacturing. Computer Aided Chemical Engineering 2007, 24, 589.

    OpenUrl
44. 44.↵
    1. Langer E. S.,
    2. Rader R. A.

    Continuous Bioprocessing and Perfusion: Wider Adoption Coming as Bioprocessing Matures. BioProcessing Journal 2014, 13 (1), 43–49.

    OpenUrl
45. 45.↵
    1. Acuna J.,
    2. Hewitt M.,
    3. Johnston R.,
    4. Kirkland D.,
    5. Shikibu T.,
    6. Zhang D.

    Modeling Perfusion Processes in Biopharmaceutical Production. BioProcess International 2011, 9 (2), 52–58.

    OpenUrl
46. 46.↵
    1. Reed L. J.,
    2. Berkson J.

    The Application of the Logistic Function to Experimental Data. J. Phys. Chem. 1929, 33 (5), 760–779.

    OpenUrlCrossRefWeb of Science
47. 47.↵
    1. Griliches Z.

    Hybrid Corn: An Exploration in the Economics of Technological Change. Econometrica, Journal of the Econometric Society 1957, 25 (4), 501–522.

    OpenUrl
48. 48.↵
    1. Steury T. D.,
    2. Murray D. L.

    Modeling the Reintroduction of Lynx to the Southern Portion of Its Range. Biological Conservation 2004, 117 (2), 127–141.

    OpenUrl
49. 49.↵
    1. Whitford W. G.

    Single-use Systems as Principal Components in Bioproduction. BioProcess International 2010, 8 (11), 34–42.

    OpenUrl
50. 50.↵
    1. Ashouri P.

    A Dynamic Simulation Framework for Biopharmaceutical Capacity Management, Ph.D. thesis, University College London, 2011.
51. 51.↵
    1. Lim A. C.,
    2. Washbrook J.,
    3. Titchener-Hooker N. J.,
    4. Farid S. S.

    A Computer-aided Approach To Compare the Production Economics of Fed-batch and Perfusion Culture under Uncertainty. Biotechnol. Bioeng. 2006, 93 (4) 687–697.

    OpenUrlPubMed