Process Scale Purification of Antibodies
close menu
Bookswagon
search
My Account
Home > Medical specialties, branches of medicine > Pharmacology > Process Scale Purification of Antibodies
Process Scale Purification of Antibodies

Process Scale Purification of Antibodies


     0     
5
4
3
2
1



Out of Stock


Notify me when this book is in stock
X
About the Book

Traditional column chromatography dominates current purification technology, and many of the productivity gains that have been achieved have relied on upscaling such devices. However, this comes with a cost penalty and the pharmaceutical industry has reached the point at which further upscaling becomes economically unsupportable. This book offers a broad-based reassessment of old and new purification methods, incorporating an analysis of innovative new trends in purification. The book has wide coverage of different antibody purification strategies and brings together top-tier experts to address problems in process-scale antibody purification.

Table of Contents:
Preface. About the Author. Contributors. Chapter 1: Downstream Processing of Monoclonal Antibodies: Current Practices and Future Opportunities (Brian Kelly, Greg Blank and Ann Lee). 1.1 Introduction. 1.2 A Brief History of cGMP mAb and Intravenous Immunoglobulin IgIV Purification. 1.3 Current Approaches in Purification Process Development: Impact of Platform Processes. 1.4 Typical Unit Operations and Processing Alternatives. 1.5 VLS Processes: Ton-scale Production and Beyond. 1.6 Process Validation. 1.7 Product Life-cycle Management. 1.8 Future Opportunities. 1.9 Conclusions . 1.10 Acknowledgments. 1.11 References. Chapter 2: The Development of Antibody Purification Technologies (John Curling). 2.1 Introduction. 2.2 Chromatographic Purification of Antibodies Before Protein A. 2.3 Antibody Purification After 1975. 2.4 Additional Technologies for Antibody Purification. 2.5 Purification of mAbs Approved in North America and Europe. 2.6 Acknowledgments. 2.7 References . Chapter 3: Harvest and Recovery of Monoclonal Antibodies: Cell Removal and Clarification (Abhinav A. Shukla and Jagannadha Rao Kandula). 3.1 Introduction. 3.2 Centrifugation. 3.3 Microfiltration. 3.4 Depth Filtration. 3.5 Flocculation. 3.6 Absolute Filtration. 3.7 Expanded-Bed Chromatography. 3.8 Comparison of Harvest and Clarification of Unit Operations. 3.9 Acknowledgments. 3.10 References. Chapter 4: Protein A-Based Affinity Chromatography (Suresh Vunnum, Ganesh Vedantham and Brian Hubbard). 4.1 Introduction. 4.2 Properties of Protein A and Commercially-Available Protein A Resins. 4.3 Protein A Chromatography Step Development. 4.4 Additional Considerations during Development and Scale-up. 4.5 Virus Removal/Inactivation. 4.6 Validation and Robustness. 4.7 Conclusions. 4.8 Acknowledgments. 4.9 References. Chapter 5: Purification of Human Monoclonal Antibodies: Non-Protein A Strategies (Alahari Arunakumari and Jue Wang). 5.1 Introduction. 5.2 Integrated Process Designs for Human Monoclonal Antibody (HuMab) Production. 5.3 Purification Process Designs for HuMabs. 5.4 Conclusions . 5.5 Acknowledgments. 5.6 References. Chapter 6: Purification of Monoclonal Antibodies by Mixed Mode Chromatography (Pete Gagnon). 6.1 Introduction. 6.2 A Brief History. 6.3 Prerequisites for Industrial Implementation. 6.4 Mechanisms, Screening and Method Development. 6.5 Capture Applications. 6.6 Polishing Applications. 6.7 Sequential Capture/Polishing Applications. 6.8 The Future. 6.9 Acknowledgments. 6.10 References. Chapter 7: Integrated Polishing Steps for Monoclonal Antibody Purification (Sanchayita Ghose, Mi Jin, Jin Liu and John Hickey). 7.1 Introduction. 7.2 Polishing Steps in Antibody Purification. 7.3 Integration of Polishing Steps. 7.4 Conclusions. 7.5 Acknowledgments. 7.6 References. Chapter 8: Orthogonal Virus Clearance Applications in Monoclonal Antibody Production (Joe X Zhou). 8.1 Introduction. 8.2 Model Viruses and Virus Assays. 8.3 Virus Clearance Strategies from First in Human (FIH) to Biological License Application (BLA) Filing. 8.4 Orthogonal Viral Clearance in mAB Production. 8.5 Conclusions and Future Perspectives. 8.6 Acknowledgments. 8.7 References. Chapter 9: Development of A Platform Process for the Purification of Therapeutic Monoclonal Antibodies (Yuling Li, David W. Kahn, Olga Galperina, Erich Blatter, Robert Luo, Yaling Wu and Guihang Zhang). 9.1 Introduction. 9.2 Chromatography Steps in the Platform Process. 9.3 Virus Inactivation. 9.4 UF/DF Platform Development. 9.5 Platform Development: Virus Filtration and Bulk Fill. 9.6 Examples of Platform Processes. 9.7 Developing a Viral Clearance Database using a Platform Process. 9.8 Summary. 9.9 References. Chapter 10: Advances in Technology and Process Development for Industrial Scale Monoclonal Antibody Purification (Nuno Fontes and Robert van Reis). 10.1 Introduction. 10.2 Affinity Purification Platform. 10.3 Advances in CEX Purification of mABs. 10.4 HPTFF. 10.5 A New Nonaffinity Platform. 10.6 References. Chapter 11: Continuous Chromatography for the Purification of Monoclonal Antibodies (Thomas Müller-Späth and Massimo Morbidelli). 11.1 Introduction. 11.2 Product Variants and the Separation Problem. 11.3 Definition of Performance Parameters. 11.4 Gradient Chromatography for Biomolecules. 11.5 Continuous Chromatography to Increase Productivity. 11.6 The MCSGP Process. 11.7 Upgrades for Continuous Processes to Improve Stability. 11.8 Impact of Increasing Fermentation Titers. 11.9 Outlook. 11.10 Acknowledgments. 11.11 References. Chapter 12: Process Economic Drivers in Industrial Monoclonal Antibody Manufacture (Suzanne S. Farid). 12.1 Introduction. 12.2 Challenges When Striving for the Cost-Effective Manufacture of mAbs. 12.3 Cost Definitions and Benchmark Values. 12.4 Economies of Scale. 12.5 Overall Process Economic Drivers. 12.6 DSP Drivers at High Titers. 12.7 Process Economic Trade-Offs for DSP Bottlenecks. 12.8 Summary and Outlook. 12.9 References. Chapter 13: Design and Optimization of Manufacturing (Andrew Sinclair). 13.1 Introduction. 13.2 Process Design and Optimization. 13.3 Modeling Approaches. 13.4 Cost Models in Practice. 13.5 Simulation in Practice. 13.6 Acknowledgments. 13.7 References. Chapter 14: Alternatives to Packed-Bed Chromatography for Antibody Extraction and Purification (Jörg Thömmes and Uwe Gottschalk). 14.1 Introduction. 14.2 Increasing the Selectivity of Harvest Procedures: Flocculation of Particulate and Nonparticulate Impurities. 14.3 Solutions for Antibody Extraction, Concentration and Purification. 14.4 Nonchromatographic Solutions for Antibody Purification and Formulation. 14.5 Membrane Adsorbers. 14.6 Conclusions. 14.7 Acknowledgments. 14.8 References. Chapter 15: Process-Scale Precipitation of Impurities in Mammalian Cell Culture Broth (Judy Glynn). 15.1 Introduction. 15.2 Precipitation of DNA and Protein - Other Applications. 15.3 A Comprehensive Evaluation of Potential Precipitants for Impurity Removal. 15.4 Industrial-Scale Precipitation. 15.5 Cost of Goods in Comparison. 15.6 Summary. 15.7 Acknowledgments. 15.8 References. Chapter 16: Charged Ultrafiltration and Microfiltration Membranes in Antibody Purification (Mark R. Etzel). 16.1 Introduction. 16.2 Charged Ultrafiltration Membranes. 16.3 Concentration Polarization and Permeate Flux. 16.4 Stagnant Film Model. 16.5 Osmotic Pressure Model. 16.6 Mass Transfer Coefficient. 16.7 Sieving Coefficient. 16.8 Diffusion Convection Model. 16.9 Scale-up Strategies and the Constant Wall Concentration (Cw) Approach. 16.10 Protein Fractionation Using Charged Ultrafiltration Membranes. 16.11 Case Study. 16.12 Membrane Cascades. 16.13 Charged Microfiltration Membranes. 16.14 Virus Clearance. 16.15 Salt Tolerance. 16.16 Conclusions. 16.17 Acknowledgments. 16.18 References. Chapter 17: Downstream Processing of Monoclonal Antibody Fragments (Mariangela Spitali). 17.1 Introduction. 17.2 Production of Antibody Fragments for Therapeutic Use. 17.3 Downstream Processing. 17.4 Improving the Pharmacological Characteristics of Antibody Fragments. 17.5 Conclusions. 17.6 Acknowledgments. 17.7 References . Chapter 18: Purification of Antibodies Other Than IgG - The Case of IgM and IgA (Charlotte Cabanne and Xavier Santarelli). 18.1 Introduction. 18.2 Purification of Immunoglobulin M (IgM). 18.3 Purification of IgA. 18.4 Conclusion. 18.5 Acknowledgments. 18.5 References. Chapter 19: Purification of Antibodies From Transgenic Plants (Zivko L. Nikolov, Jeffrey T. Regan, Lynn F. Dickey and Susan L. Woodward). 19.1 Introduction. 19.2 Antibody Production in Transgenic Plants. 19.3 Downstream Processing of Antibodies Produced in Transgenic Plants. 19.4 Purification of Plant-Derived mAbs using Protein A. 19.5 Purification of Plant-Derived mAbs using Non-Protein A Media. 19.6 Polishing Steps. 19.7 Conclusions. 19.8 Acknowledgments. 19.9 References . Chapter 20: Antibody Purification: Drivers of Change (Narahari Pujar, Duncan Low and Rhona O’Leary). 20.1 Introduction. 20.2 The Changing Regulatory Environment - Pharmaceutical Manufacturing for the Twenty-First Century. 20.3 Technology Drivers - Advances and Innovations. 20.4 Economic Drivers. 20.5 Conclusions. 20.6 Acknowledgments. 20.7 References. Index.

About the Author :
Uwe Gottschalk, PhD, is Group Vice President, Purification Technologies, at Sartorius Stedim Biotech. Previously, he worked for Bayer Health Care, overseeing the purification of monoclonal antibodies and recombinant proteins produced in various expression systems. Dr. Gottschalk received a doctorate in chemistry from the University of Münster. He lectures at the University of Duisburg-Essen and the EPFL in Lausanne, Switzerland and has written extensively in the areas of biotechnology and somatic gene therapy.


Best Sellers


Product Details
  • ISBN-13: 9780470444887
  • Publisher: John Wiley & Sons Inc
  • Publisher Imprint: Wiley-Interscience
  • Language: English
  • ISBN-10: 0470444886
  • Publisher Date: 28 Jan 2009
  • Binding: Digital (delivered electronically)
  • No of Pages: 456


Similar Products

Add Photo
Add Photo

Customer Reviews

REVIEWS      0     
Click Here To Be The First to Review this Product
Process Scale Purification of Antibodies
John Wiley & Sons Inc -
Process Scale Purification of Antibodies
Writing guidlines
We want to publish your review, so please:
  • keep your review on the product. Review's that defame author's character will be rejected.
  • Keep your review focused on the product.
  • Avoid writing about customer service. contact us instead if you have issue requiring immediate attention.
  • Refrain from mentioning competitors or the specific price you paid for the product.
  • Do not include any personally identifiable information, such as full names.

Process Scale Purification of Antibodies

Required fields are marked with *

Review Title*
Review
    Add Photo Add up to 6 photos
    Would you recommend this product to a friend?
    Tag this Book Read more
    Does your review contain spoilers?
    What type of reader best describes you?
    I agree to the terms & conditions
    You may receive emails regarding this submission. Any emails will include the ability to opt-out of future communications.

    CUSTOMER RATINGS AND REVIEWS AND QUESTIONS AND ANSWERS TERMS OF USE

    These Terms of Use govern your conduct associated with the Customer Ratings and Reviews and/or Questions and Answers service offered by Bookswagon (the "CRR Service").


    By submitting any content to Bookswagon, you guarantee that:
    • You are the sole author and owner of the intellectual property rights in the content;
    • All "moral rights" that you may have in such content have been voluntarily waived by you;
    • All content that you post is accurate;
    • You are at least 13 years old;
    • Use of the content you supply does not violate these Terms of Use and will not cause injury to any person or entity.
    You further agree that you may not submit any content:
    • That is known by you to be false, inaccurate or misleading;
    • That infringes any third party's copyright, patent, trademark, trade secret or other proprietary rights or rights of publicity or privacy;
    • That violates any law, statute, ordinance or regulation (including, but not limited to, those governing, consumer protection, unfair competition, anti-discrimination or false advertising);
    • That is, or may reasonably be considered to be, defamatory, libelous, hateful, racially or religiously biased or offensive, unlawfully threatening or unlawfully harassing to any individual, partnership or corporation;
    • For which you were compensated or granted any consideration by any unapproved third party;
    • That includes any information that references other websites, addresses, email addresses, contact information or phone numbers;
    • That contains any computer viruses, worms or other potentially damaging computer programs or files.
    You agree to indemnify and hold Bookswagon (and its officers, directors, agents, subsidiaries, joint ventures, employees and third-party service providers, including but not limited to Bazaarvoice, Inc.), harmless from all claims, demands, and damages (actual and consequential) of every kind and nature, known and unknown including reasonable attorneys' fees, arising out of a breach of your representations and warranties set forth above, or your violation of any law or the rights of a third party.


    For any content that you submit, you grant Bookswagon a perpetual, irrevocable, royalty-free, transferable right and license to use, copy, modify, delete in its entirety, adapt, publish, translate, create derivative works from and/or sell, transfer, and/or distribute such content and/or incorporate such content into any form, medium or technology throughout the world without compensation to you. Additionally,  Bookswagon may transfer or share any personal information that you submit with its third-party service providers, including but not limited to Bazaarvoice, Inc. in accordance with  Privacy Policy


    All content that you submit may be used at Bookswagon's sole discretion. Bookswagon reserves the right to change, condense, withhold publication, remove or delete any content on Bookswagon's website that Bookswagon deems, in its sole discretion, to violate the content guidelines or any other provision of these Terms of Use.  Bookswagon does not guarantee that you will have any recourse through Bookswagon to edit or delete any content you have submitted. Ratings and written comments are generally posted within two to four business days. However, Bookswagon reserves the right to remove or to refuse to post any submission to the extent authorized by law. You acknowledge that you, not Bookswagon, are responsible for the contents of your submission. None of the content that you submit shall be subject to any obligation of confidence on the part of Bookswagon, its agents, subsidiaries, affiliates, partners or third party service providers (including but not limited to Bazaarvoice, Inc.)and their respective directors, officers and employees.

    Accept

    Fresh on the Shelf


    Inspired by your browsing history


    Your review has been submitted!

    You've already reviewed this product!
    Your IP: 216.73.216.237 IN