Purification Tools For Monoclonal Antibodies

Purification Tools for Monoclonal is an essential book for professionals, educators and advanced students in the field of Biotechnology. It is based on experience gained from purification process development, scale-up, and manufacture of more than 250 monoclonal-based diagnostic and therapeutic products. Ten chapters provide in-depth coverage of major separation mechanisms, process strengths, weaknesses and method development; all fully integrated with the special performance, economic and validation requirements associated with monoclonals. Covered methods include precipitation with inorganic salts, polyethylene glycol, electrolyte depletion, caprylic acid, ethacridine, chromatographic purification by size exclusion, ion exchange, hydroxyapatite, hydrophobic interaction, immobilized metal affinity, hydrophilic interaction, euglobulin adsorption, thiophilic adsorption, protein A, protein G, lectin affinity, and more. 88 figures, 29 tables.

Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing

If the antibody industry is to achieve its full potential in the next decade, the individual technical potentials must be exploited, the limitations must be addressed, and lessons learned must be applied both to current purification methods and to the new technologies that continue to emerge. This book presents an overview of the current advances applied in the manufacture of monoclonal antibody including: -concepts in development of manufacturing strategies, -importance of antibody fragments, -application of chromatography method development, -quality control, -effect of expression on antibody properties, -virus removal and safety, -pharmacokinetics, -regulatory aspects.

This second edition volume expands on the previous edition with descriptions of recent developments in the field. The chapters in this book cover topics such as monoclonal antibodies for the treatment of melanoma; production and purification of human monoclonal antibodies; humanization and optimization of monoclonal antibodies; rapid chimerization of monoclonal antibodies; epitope mapping via phage display from single gene libraries; recombinant antibodies made by combining phage and yeast display selections; production of stabilized antibody fragments in the E. coli bacterial cytoplasm and transfected mammalian cells; and analysis of CAR T cells. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Unique and thorough, Human Monoclonal Antibodies: Methods and Protocols, Second Edition is a valuable tool for novice and expert researchers interested in learning more about this evolving field.

The present new version of this popular laboratory manual is at the same time the first one of this text in the English language - and this makes me even a little proud, as it reminds me of probably the first collection of monoclonal recipes in English, written by myself, which circulated for a couple of years in many laboratories. In the meantime many researchers have put enormous effort into improving methods for monoclonal antibody production. The proce dures have become more and more standardized and by this have more and more lost the character of magic secrets. Hinrich Peters and Horst Baumgarten, who had followed this good tradition already in the previous edition, written in German, suc ceeded in making laboratory tricks teachable. They had contributed their own experiences in cell culture and immunology, and were able to engage a number of experienced authors to contribute to the work. They were all willing to follow the general concept of this book, which contains a brief theoretical background for the methods described and presents the procedures in a highly organized structure. So the book has retained its shape as a "cook-book", which I especially like.

The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.

"Distributed in print by Oxford University Press."

Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography