REFERENCES
- Shukla , A.A. ; Etzel , M.R. ; Gadam , S. Process Scale Bioseparation for the Biopharmaceutical Industry . Taylor & Francis , New York , NY , 2007 pp. 297 – 332 .
- Olson , W.P. Separations Technology: Pharmaceutical and Biotechnology Applications . Interpharm Press , Buffalo Grove , IL , 1995 pp. 122 – 130 .
- Dosmar , M. An Experimental Approach to Optimization of Ultrafiltration . Bioprocess Int. 2006 , 4 ( 10 ), 44 – 54 .
- Rathore , A.S. ; Wang , A. ; Menon , M. ; Riske , F. ; Campbell , J. ; Goodrich , E. ; Martin , J. Optimization, Scale-up and Validation Issues in Filtration of Biopharmaceuticals—Part I and Par II . Biopharm. Int. 2004 , 17 ( 9 ), 42 – 58 .
- Van Reis , R. ; Zydney , A. Bioprocess Membrane Technology . J. Membr. Sci. 2007 , 297 , 16 – 50 .
- Kandula , S. ; Badu , S. ; Jin , M. ; Shukla , A.A. Design of a Filter Train for Precipitate Removal in Monoclonal Antibody Downstream Processing . Biotechnol. Appl. Biochem. 2009 , 54 ( 3 ), 149 – 155 .
- Pattnaik , P. ; Louis , I. ; Mahadevan , M.S. Use of Membrane Technology in Bioprocessing Therapeutic Proteins From Inclusion Bodies of E. Coli . Bioprocess Int. 2009 , 7 ( 3 ), 54 – 62 .
- Yigzaw , Y. ; Piper , R. ; Tran , M. ; Shukla , A.A. Exploitation of the Adsorptive Properties of Depth Filters for Host Cell Protein Removal During Monoclonal Antibody Purification . Biotechnol. Progr. 2006 , 22 ( 1 ), 288 – 296 .
- Kumar , R. ; Kapre , S.V. ; Pattnaik , P. ; Mahadevan , M.S. Tangential Flow Filtration for the Recovery of Acellular Pertussis Vaccine Components . Biopharm Int. Supplements , October 2009 .
- Kuczewski , M. ; Schirmer , E. ; Lain , B. ; Zarbis-Papastoitsis , G. A Single-Use Purification Process for the Production of a Monoclonal Antibody Produced in a PER. C6 Human Cell Line . Biotechnol. J . 2011 , 6 ( 1 ), 56 – 65 .
- Peixoto , C. ; Ferreira , T.B. ; Sousa , M.F.Q. ; Carrondo , M.J.T. ; Alves , P.M. Towards Purification of Adenoviral Vectors Based on Membrane Technology . Biotechnol. Progr. 2008 , 24 ( 6 ), 1290 – 1296 .
- Hongo-Hirasaki , T. ; Yamaguchi , K. ; Yanagida , K. ; Okuyama , K. Removal of Small Viruses (Parvovirus) From IgG Solution by Virus Removal Filter Planova®20 N. J. Membr. Sci. 2006, 278(1–2), 3–9.
- Michalsky , R. ; Passarelli , A.L. ; Pfromma , P.H. ; Czermak , P. Concentration of the Baculovirus Autographa californica M Nucleopolyhedrovirus (AcMNPV) by Ultrafiltration . Desalination 2010 , 250 , 1125 – 1127 .
- Luo , R. ; Waghmare , R. ; Krishnan , M. ; Adams , C. ; Poon , E. ; Kahn , D. High-Concentration UF/DF of a Monoclonal Antibody: Strategy for Optimization and Scale-Up . Bioprocess Int. 2006 , 4 ( 2 ), 44 – 48 .
- Latulippe , D.R. ; Ager , K. ; Zydney , A.L. Flux Dependent Ttransmission of Supercoiled Plasmid DNA Through Ultrafiltration Membranes . J. Membr. Sci. 2007 , 294 , 169 – 177 .
- Grzenia , D.L.; Carlson J.O. ; Wickramasinghe , S.R. Tangential Flow Filtration for Virus Purification . J. Membr. Sci. 2008 , 321 , 373 – 380 .
- Rosenberg , E. ; Hepbildikler , S. ; Kuhne , W. ; Winter , G. Ultrafiltration Concentration of Monoclonal Antibody Solutions: Development of an Optimized Method Minimizing Aggregation . J. Membr. Sci. 2009 , 342 ( 1–2 ), 50 – 59 .
- Baruah , G.L. ; Nayak , A. ; Winkelman , E. ; Belfort , G. Purification of Monoclonal Antibodies Derived From Transgenic Goat Milk by Ultrafiltration . Biotechnol. Bioeng. 2006 , 93 ( 4 ), 247 – 254 .
- Molek , J.R. ; Zydney , A.L. Separation of PEGylated α -Lactalbumin from Unreacted Precursors and Byproducts Using Ultrafiltration . Biotechnol. Progr. 2007 , 23 , 1417 – 1424 .
- Aspelund , M.T. ; Glatz , C.E. Purification of Recombinant Plant-made Proteins from Corn Extracts by Ultrafiltration . J. Membr. Sci. 2010 , 353 ( 1–2 ), 103 – 110 .
- Krishna Rao , D.V. ; Tulasi Ramu , C. ; Venkateswara Rao , J. ; Lakshmi Narasu , M. ; Bhujanga Rao , A.K.S. Cloning, High Expression and Purification of Recombinant Human Intereferon-β-1b in Escherichia coli . Appl. Biochem. Biotechnol. 2009 , 158 ( 1 ), 140 – 154 .
- Glynn , J. ; Hagerty , T. ; Pabst , T. ; Annathur , G. ; Thomas , K. ; Johnson , P. ; Ramasubramanyan , N. ; Mensah , P. The Development and Application of a Monoclonal Antibody Purification Platform . Biopharm Int. Supplements October 2009 .
- Shukla , A.A. ; Kandula , J.R. Harvest and Recovery of Monoclonal Antibodies From Large-Scale Mammalian Cell Culture . Biopharm Int. 2008 , 21 ( 5 ), 34 – 45 .
- Tarrach , K. ; Köhler , K. ; Grimm , C. Managing Initial Recovery Processes with Multilayer Depth Filtration . Pharm. Technol. Europe. 2008 , 20 ( 4 ), 71 – 77 .
- Wang , A. ; Lewus , R. ; Rathore , A.S. Comparison of Different Options for Harvest of a Therapeutic Protein Product for High Cell Density Fermentation Broth . Biotechnol. Bioeng. 2005 , 94 , 91 – 104 .
- Lowa , D. ; O'Leary , R. ; Pujar , N.S. Future of Antibody Purification . J. Chromatogr. B 2007 , 848 , 48 – 63 .
- Glynn , J. ; Boyle , D. ; Wealand , J. ; Miller-Cary , E. ; Chen , B. ; Mensah , P. Advances in Monoclonal Antibody Purification . Biopharm. Int. Suppl. March 2010 .
- Removal of Host Cell Proteins by Zeta Plus™ Filters during Monoclonal Antibody Purification. CUNO (a 3 M Company), Application Brief. http://www.cuno.com/healthcare/pdfs/products/zeta_ext_za.pdf
- Strathmann , H. Membrane and Membrane Processes in Biotechnology . Trends Biotechnol. 1985 , 3 ( 5 ), 112 – 118 .
- Saxena , A. ; Tripathi , B.P. ; Kumar , M. ; Shahi , V.K. Membrane-Based Techniques for the Separation and Purification of Proteins: An Overview . Adv. Colloid Interface Sci. 2009 , 145 , 1 – 22 .
- Cardona , M. ; Martin , C. Pleated Membrane Filters Improve Process Economics . Biopharm. Int. 2005 , 18 ( 1 ), 20 – 24 .
- UF Membranes Targeted at Biotechnology Markets . Membr. Technol. 2005 , 2005 ( 11 ), 2 .
- Ultrafiltration Membranes: Ultrafiltration Membranes for Macromolecule Processing. Millipore Product Selection Guide, Lit. No. PF1172EN00.
- Ghosh , R. Protein Separation Using Membrane Chromatography Opportunities and Challenges . J. Chromatogr. A. 2002 , 952 , 13 – 27 .
- Almecija , M.C. ; Ibanez , R. ; Guadix , A. ; Guadix , E.M. Effect of pH on the Fractionation of Whey Proteins with a Ceramic Ultrafiltration Membrane . J. Membr. Sci. 2007 , 288 , 28 – 35 .
- Kerasep®-Bio:Modules and Systems for Ceramic TFF Membranes. http://www.novasep.com/biomolecules/biopharma/tff/modules-systems.asp
- Van Reis , R. ; Zydney , A. Membrane Separations in Biotechnology. Curr. Opin. Biotechnol. 2001, 12(2), 208–211.
- Charcosset , C. Membrane Processes in Biotechnology: An Overview . Biotechnol. Adv. 2006 , 24 , 482 – 492 .
- Liu , X. ; Collins , M. ; Fraud , N. ; Campbell , J. ; Lowenstein , I. ; Lacki , K.M. ; Rathore , A.S. Upcoming Technologies to Facilitate More Efficient Biologics Manufacturing . Biopharm Int. 2009 , 22 ( 2 ), 38 – 51 .
- Shrivastava , A. ; Kumar , S. ; Cussler , E.L. Predicting The Effect of Membrane Spacers on Mass Transfer . J. Membr. Sci. 2008 , 323 , 247 – 256 .
- Clarification of Pichia pastoris Using Cross Flow Microfiltration. GE Healthcare Application Note 18-1177-28 AC .
- Ray , S. ; Tarrach , K. Virus Clearance Strategy Using a Three-Tier Orthogonal Technology Platform . Biopharm Int. 2008 , 21 ( 9 ), 50 – 59 .
- Leach , G. Fine Chemical Processing: New Vibrating Membrane System for Biotech . Filtr. Sep. 2008 , 45 ( 4 ), 29 – 31 .
- Postlethwaite , J. ; Lamping , S.R. ; Leach , G. ; Hurwitz , M.F. ; Lye , G.J. Flux and transmission characteristics of a Vibrating Microfiltration System Operated at High Biomass Loading . J. Membr. Sci. 2008 , 228 , 89 – 101 .
- Davies , J. A Purification Platform for the Production of MAbs from Fermenters with Titers of 5 g/L and Beyond . Biopharm Int. Supplements March 2009 .
- Rathore , A.S. ; Winkle , H. Quality by Design for Pharmaceuticals: Regulatory Perspective and Approach . Nat. Biotechnol. 2009 , 27 , 26 – 34 .
- Read , E.K. ; Park , J.T. ; Shah , R.B. ; Riley , B.S. ; Brorson , K.A. ; Rathore , A.S. Process. Analytical Technology (PAT) for Biopharmaceutical Products: Concepts and Applications—Part I . Biotechnol. Bioeng. 2010 , 105 , 276 – 284 .
- Read , E.K. ; Park , J.T. ; Shah , R.B. ; Riley , B.S. ; Brorson , K.A. ; Rathore , A.S. Process Analytical Technology (PAT) for Biopharmaceutical Products: Concepts and Applications—Part II . Biotechnol. Bioeng. 2010 , 105 , 285 – 295 .
- Thommes , J. ; Etzel , M. Alternative to Chromatographic Separations . Biotechnol. Progr. 2007 , 23 , 42 – 45 .
- Christy , C. ; Adams , G. ; Kuriyel , R. ; Bolton , G. ; Seilly , A. High-Performance Tangential Flow Filtration: A Highly Selective Membrane Separation Process . Desalination 2002 , 144 , 133 – 136 .
- Van Reis , R.J.M. ; Brake , J.M. ; Charkoudian , M. ; Burns , D.B. ; Zydney , A.L. High Performance Tangential Flow Filtration Using Charged Membranes . J. Membr. Sci. 1999 , 159 , 133 – 142 .
- Van Reis , R. ; Gadam , S. ; Frautschy , L.N. ; Orlando , S. ; Goodrich , E.M. ; Saksena , S. ; Kuriyel , R. ; Simpson , C.M. ; Pearl , S. ; Zydney , A.L. High Performance Tangential Flow Filtration . Biotechnol. Bioeng. 1997 , 56 ( 1 ), 71 – 82 .
- Lebreton , B. ; Brown , A. ; Van Reis , R. Application of High Performance Tangential Flow Filtration (HPTFF) to the Purification of a Human Pharmaceutical Antibody Fragment Expressed in Escherichia coli . Biotechnol. Bioeng. 2008 , 100 ( 5 ), 964 – 974 .
- Mayani , M. ; Carlos , D.M. ; Filipe , C.D.M. ; Ghosh , R. Cascade Ultrafiltration Systems—Integrated Processes for Purification and Concentration of Lysozyme . J. Membr. Sci. 2010 , 347 , 150 – 158 .
- Mohanty , K. ; Ghosh , R. Novel Tangential-Flow Countercurrent Cascade Ultrafiltration Configuration for Continuous Purification of Humanized Monoclonal Antibody . J. Membr. Sci. 2008 , 307 ( 1 ), 117 – 125 .
- País-Chanfrau , J.M. ; Zorrilla , K. ; Chico , E. The impact of Disposables on Project Economics in a New Antibody Plant: A Case Study . Biopharm Int. 2009 , 22 ( 12 ), 62 – 74 .
- Diblasi , K. ; Jornitz , M.W. ; Gottschalk , U. ; Priebe , P.M. Disposable Biopharmaceutical Processes-Myth or Reality? Biopharm Int. 2007 , 20 ( 10 suppl. ), 19 – 24 .
- Gottschalk , U. Disposables in downstream processing . Adv. Biochem. Eng./Biotechnol. 2010 , 115 , 171 – 183 .
- Charles , I. ; Lee , J. ; Dasarathy , Y. Single-Use Technologies—A Contract Biomanufacturer's Perspective . Biopharm Int. Supplements , November 2007 .
- Langer , E. Downstream Disposables: The Missing Link in The Disposables Chain . Biopharm Int. 2010 , 23 ( 8 ), 22 – 23 .
- Gottschalk , U. Disposable Decisions. Biopharm Int. 2008, 21(10), 105.
- LaBreck , M. ; Perreault , M. An Economic Analysis of Single-Use Tangential Flow Filtration for Biopharmaceutical Applications . Biopharm Int. 2010 , 23 ( 11 suppl. ), 32 – 38 .
- Robinson , J.M. An Alternative to the Scale-up and Distribution of Pandemic Influenza Vaccine . Biopharm Int. Supplements , January 2009 .
- Gottschalk , U. Bioseparation in Antibody Manufacturing: The Good, The Bad, and The Ugly . Biotechnol. Progr. 2008 , 24 , 496 – 503 .
- Rathore , A.S. A Roadmap for Implementation of Quality by Design (QbD) for Biotechnology Products . Trends Biotechnol. 2009 , 27 , 546 – 553 .
- Nfor , B.K. ; Verhaert , P.D. ; van der Wielen , L.A. ; Hubbuch , J. ; Ottens , M. Rational and Systematic Protein Purification Process Development: The Next Generation . Trends Biotechnol. 2009 , 27 ( 12 ), 673 – 679 .
- Bhambure , R. ; Kumar , K. ; Rathore , A.S. High Throughput Process Development for Biopharmaceutical Products: Review . Trends Biotechnol. 2010 , doi: 10.1016/j.tibtech.2010.12.001 .
- Ghosh , R. ; Wan , Y. ; Cui , Z. ; Hale , G. Parameter Scanning Ultrafiltration Rapid Optimisation of Protein Separation . Biotechnol. Bioeng. 2003 , 81 ( 6 ), 673 – 682 .
- Ma , G. ; Aucamp , J. ; Gerontas , S. ; Eardley-Patel , R. ; Craig , A. ; Hoare , M. ; Zhou , Y. Mimic of a Large-Scale Diafiltration Process by Using Ultra Scale-Down Rotating Disc Filter . Biotechnol. Progr. 2010 , 26 ( 2 ), 466 – 476 .
- Vandezande , P. ; Gevers , L.E.M. ; Paul , J.S. ; Vankelecom , I.F.J. ; Jacobs , P.A. High Throughput Screening for Rapid Development of Membranes and Membrane Processes . J. Membr. Sci. 2005 , 250 , 305 – 310 .
- Chandler , M. ; Zydney , A. High Throughput Screening for Membrane Process Development . J. Membr. Sci. 2004 , 237 , 181 – 188 .
- Seeley , K. ; Bricman , Y. High Throughput Genomic and Proteiomic Sample Preparation . Laboratory Focus. 2004 .
- Kokpinar , O. ; Harkensee , D. ; Kasper , C. ; Sceper , T. ; Zeidler , R. ; Reif , O.-W. ; Ulber , R. Innovative Modular Membrane Adsorber System for High-Throughput Downstream Screening for Protein Purification . Biotechnol. Progr. 2006 , 22 , 1215 – 1219 .
- Ivanova , N.V. ; Dewaard , J.R. ; Hebert , P.N. An Inexpensive, Automation-Friendly Protocol for Recovering High-quality DNA . Mol. Ecol. Notes 2006 , 6 , 998 – 1002 .
- Ivanova , N.V. ; Fazekas , A.J. ; Hebert , P.D.N. Semi-Automated, Membrane-Based Protocol for DNA Isolation From Plants . Plant Mol. Biol. Rep. 2008 , 26 , 186 – 198 .
- MultiScreen® Filter Plate with Ultracel®-10 Membrane: Enzymatic Activity Recovery. Millipore Application Note, Literature no. AN2011EN00.
- MultiScreen Filter Plate with Ultracel-10 Membrane: Protein Retention, Recovery, Volume Recovery, and Guidelines for Concentration and Desalting. Millipore Protocol Note, Literature no. PC1025EN00.
- Efficient Multi-Well Protein Purification Strategies. Pall Life Sciences, Application Note no. PN 33576.
- Shukla , A.A. ; Thommes , J. Recent Advances in Large-scale Production of Monoclonal Antibodies and Related Proteins . Trends Biotechnol. 2010 , 28 ( 5 ), 253 – 261 .
- Zhou , J.X. ; Tressel , T. Basic Concepts in Q Membrane Chromatography for Large-Scale Antibody Production . Biotechnol. Progr. 2006 , 22 , 341 – 349 .
- Bhuta , B.V. ; Christensenb , K.A. ; Hussona , S.M. Membrane Chromatography: Protein Purification from E. coli Lysate using Newly Designed and Commercial Anion-exchange Stationary Phases . J. Chromatogr. A 2010 , 1217 , 4946 – 4957 .
- Boi , C. Membrane Adsorbers as Purification Tools for Monoclonal Antibody Purification . J. Chromatogr. B. 2007 , 848 , 19 – 27 .
- Warner , T.N. ; Nochumson , S. Innovations of Membrane Chromatography for Biomolecular Purification . Pharm. Technol. North Am. 2002 , 26 ( 9 ), 36 – 42 .
- Zhou , J.X. ; Tressel , T. ; Gottschalk , U. ; Solamo , F. ; Pastor , A. ; Dermawan , S. ; Hong , T. ; Reif , O. ; Mora , J. ; Hutchison , F. ; Murphy , M. New Q Membrane Scale-down Model for Process-scale Antibody Purification . J. Chromatogr. A 2006 , 1134 , 66 – 73 .
- Gottschalk , U. Salt Tolerant Interaction Chromatography for Large-Scale Polishing with Convective Media. Biopharm Int. Supplements , October 2009.
- Fischer-Frühholz , S. ; Zhou , D. ; Hirai , M. Sartobind STIC® Salt-Tolerant Membrane Chromatography . Nat. Methods 2010 , 7 , 12 – 13 .
- William , T. ; Riordan , W.T. ; Heilmann , S.M. ; Brorson , K. ; Seshadri , K. ; Etzel , M.R. Salt Tolerant Membrane Adsorbers for Robust Impurity Clearance . Biotechnol. Progr. 2009 , 25 ( 6 ), 1695 – 1702 .
- Phillips , M. ; Cormier , J. ; Ferrence , J. ; Dowd , C. ; Kiss , R. ; Lutz , H. ; Carter , J. Performance of a Membrane Adsorber for Trace Impurity Removal in Biotechnology Manufacturing . J. Chromatogr. A 2005 , 1078 ( 1–2 ), 74 – 82 .
- Clutterbuck , A. ; Kenworthy , J. ; Liddell , J. Endotoxin Reduction Using Disposable Membrane Adsorption Technology in cGMP Manufacturing . Biopharm Int. 2007 , 20 ( 5 ), 11 – 14 .
- Zhou , J.X. ; Solamo , F. ; Hong , T. ; Shearer , M. Viral Clearance Using Disposable Systems in Monoclonal Antibody Commercial Downstream Processing . Biotechnol. Bioeng. 2008 , 100 , 488 – 496 .
- Brown , A. ; Bill , J. ; Tully , T. ; Radhamohan , A. ; Dowd , C. Overloading Ion-exchange Membranes as a Purification Step for Monoclonal Antibodies . Biotechnology and Applied Biochemistry. 2010 , 56 , 59 – 70 .
- Peixoto , C. ; Ferreira , T.B. ; Sousa , M.F.Q. ; Carrondo , M.J.T. ; Alves , P.M. Towards Purification of Adenoviral Vectors Based on Membrane Technology . Biotechnol. Progr. 2008 , 24 ( 6 ), 1290 – 1296 .
- Giovannoni , L. ; Ventani , M. ; Gottschalk , U. Antibody Purification Using Membrane Adsorbers . Biopharm Int. 2008 , 21 ( 12 ), 48 – 52 .
- Kuczewski , M. ; Fraud , N. ; Faber , R. Zarbis-Papastoitsis , G. Development of a Polishing Step Using a Hydrophobic Interaction Membrane Adsorber With a PER.C6 Derived Recombinant Antibody . Biotechnol. Bioeng. 2010 , 105 , 296 – 305 .
- Guerrero-Germa , P. ; Prazeres , D.M.F. ; Guzma , R. ; Montesinos-Cisneros , R.M. ; Tejeda-Mansir , A. Purification of Plasmid DNA Using Tangential Flow Fltration and Tandem Anion-Exchange Membrane Chromatography . Bioprocess. Biosyst. Eng. 2009 , 32 , 615 – 623 .
- Limonta , M. ; Márquez , G. ; Pupo , M. ; Ruiz , O. The Purification of Plasmid DNA for Clinical Trials Using Membrane Chromatography . Biopharm Int. 2010 , 23 ( 2 ), 46 – 54 .
- Yu , D. ; McLean , M.D. ; Hall , J.C. ; Ghosh , R. Purification of Monoclonal Antibody from Tobacco Extract Using Membrane-Based Bioseparation Techniques . J. Membr. Sci. 2008 , 323 , 59 – 166 .
- Jacobin , M-J. ; Santarelli , X. ; Laroche-Traineau , J. ; Clofent-Sanchez , G. Production of a Human Monoclonal IgM Directed Against Human Cardiac Myosin in a Hollow-Fiber Bioreactor for Membrane Anion Exchange Chromatography One-Step Purification . Hum. Antibodies 2004 , 13 ( 3 ), 69 – 79 .
- Wang , L. ; Ghosh , R. Fractionation of Monoclonal Antibody Aggregates Using Membrane Chromatography . J. Membr. Sci. 2008 , 318 , 311 – 316 .
- Yu , D. ; Ghosh , R. Purification of PEGylated Protein Using Membrane Chromatography . Pharm. Sci. 2010 , 99 ( 8 ), 3326 – 3333 .