Throughput Optimization of Continuous Biopharmaceutical Manufacturing Facilities | PDA Journal of Pharmaceutical Science and Technology

Reference

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 Google Scholar
2.↵
1. Walsh G.
Biopharmaceutical Benchmarks 2014. Nature Biotechnol. 2014, 32 (10), 992–1000.
OpenUrl CrossRef PubMed Google Scholar
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.
Google Scholar
4.↵
1. Kelley B.
Industrialization of mAb Production Technology: The Bioprocessing Industry at a Crossroads. mAbs 2009, 1 (5), 443–452.
OpenUrl CrossRef PubMed Web of Science Google Scholar
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 Google Scholar
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 Google Scholar
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 Google Scholar
8.↵
1. Adachi K.,
2. Nishijima Y.
Continuous Process for Producing Refined Sugar, U.S. Patent 3,781,174, December 25, 1973.
Google Scholar
9.↵
1. Cole E.,
2. Howard H.
Continuous Process for Separating Oily Sludges, U.S. Patent 3,696,021, October 3, 1972.
Google Scholar
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.
Google Scholar
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 Google Scholar
12.↵
1. Anicetti V.
Biopharmaceutical Processes: A Glance into the 21st Century. BioProcess International 2009, 7 (4).
Google Scholar
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.
OpenUrl PubMed Google Scholar
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.
OpenUrl PubMed Google Scholar
15.↵
1. Konstantinov K. B.,
2. Cooney C. L.
White Paper on Continuous Bioprocessing. J. Pharm. Sci. 2015, 104 (3), 813–820.
OpenUrl Google Scholar
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.
OpenUrl PubMed Google Scholar
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 Google Scholar
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 Google Scholar
19.↵
1. Hernandez R.
Continuous Manufacturing: A Changing Processing Paradigm. BioPharm International 2015, 28 (4), 20–26.
OpenUrl Google Scholar
20.↵
1. Jagschies G.
Where Is Biopharmaceutical Manufacturing Heading? BioPharm International 2008, 21 (10), 72–88.
OpenUrl Google Scholar
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 Google Scholar
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.
OpenUrl PubMed Google Scholar
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 Google Scholar
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.
Google Scholar
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.
Google Scholar
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.
Google Scholar
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 Google Scholar
28.↵
1. Litzen D. B.,
2. Bravo J. L.
Uncover Low-cost Debottlenecking Opportunities. Chem. Eng. Prog. 1999, 95 (3), 25.
OpenUrl Google Scholar
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 Google Scholar
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 Google Scholar
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/
Google Scholar
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/
Google Scholar
33.↵
1. Gurobi I.
Optimization, Gurobi Optimizer Reference Manual, 2015. http://www.gurobi.com
Google Scholar
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 Google Scholar
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.
OpenUrl PubMed Google Scholar
36.↵
1. Holzer M.,
2. Osuna-Sanchez H.,
3. David L.
Multicolumn Chromatography. BioProcess International 2008, 6 (8), 74–84.
OpenUrl Google Scholar
37.↵
1. Bonham-Carter J.,
2. Shevitz J.
A Brief History of Perfusion Biomanufacturing. BioProcess International 2011, 9 (9), 24–30.
OpenUrl Google Scholar
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.
OpenUrl CrossRef PubMed Google Scholar
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 Google Scholar
40.↵
1. Petrides D.
Bioprocess Design and Economics; Oxford University Press: Oxford, UK, 2000.
Google Scholar
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 Google Scholar
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.
OpenUrl CrossRef Google Scholar
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 Google Scholar
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 Google Scholar
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 Google Scholar
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.
OpenUrl CrossRef Web of Science Google Scholar
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 Google Scholar
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 Google Scholar
49.↵
1. Whitford W. G.
Single-use Systems as Principal Components in Bioproduction. BioProcess International 2010, 8 (11), 34–42.
OpenUrl Google Scholar
50.↵
1. Ashouri P.
A Dynamic Simulation Framework for Biopharmaceutical Capacity Management, Ph.D. thesis, University College London, 2011.
Google Scholar
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.
OpenUrl PubMed Google Scholar