| 000 -LEADER |
|---|
| fixed length control field |
04443nam a22004575i 4500 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20140310150232.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION |
|---|
| fixed length control field |
cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
110413s2010 xxu| s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9780387766430 |
|
978-0-387-76643-0 |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RC321-580 |
| 082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
612.8 |
| Edition number |
23 |
| 264 #1 - |
|---|
| -- |
New York, NY : |
| -- |
Springer New York : |
| -- |
Imprint: Springer, |
| -- |
2010. |
| 912 ## - |
|---|
| -- |
ZDB-2-SBL |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Shire, Steven J. |
| Relator term |
editor. |
| 245 10 - IMMEDIATE SOURCE OF ACQUISITION NOTE |
|---|
| Title |
Current Trends in Monoclonal Antibody Development and Manufacturing |
| Medium |
[electronic resource] / |
| Statement of responsibility, etc |
edited by Steven J. Shire, Wayne Gombotz, Karoline Bechtold-Peters, James Andya. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
XIV, 354 p. |
| Other physical details |
online resource. |
| 440 1# - SERIES STATEMENT/ADDED ENTRY--TITLE |
|---|
| Title |
Biotechnology: Pharmaceutical Aspects ; |
| Volume number/sequential designation |
XI |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Design Of Therapeutic MABS -- CDR Repair: A Novel Approach to Antibody Humanization -- Nanobodies, Single-Domain Antigen-Binding Fragments of Camelid Heavy-Chain Antibodies -- Expression and Production of MABS -- GPEx® A Flexible Method for the Rapid Generation of Stable, High Expressing, Antibody Producing Mammalian Cell Lines -- Advancing Our Cell Culture Platform: Incorporating Lessons Learned and New Technologies -- Recovery and Purification -- Addressing Changes Associated with Technology Transfer: A Case Study -- Concepts for Disposables in Biopharmaceutical Manufacture -- Formulation and Delivery -- Formulation and Delivery Issues for Monoclonal Antibody Therapeutics -- Challenges in the Development of High Protein Concentration Formulations -- Protein Immobilization by Crystallization and Precipitation: An Alternative to Lyophilization -- Analytics and Specification Setting for MABS -- Characterizing High Affinity Antigen/Antibody Complexes by Kinetic and Equilibrium Based Methods -- Analytical Characterization of Monoclonal Antibodies: Linking Structure to Function -- Analysis of Irreversible Aggregation, Reversible Self-association and Fragmentation of Monoclonal Antibodies by Analytical Ultracentrifugation -- Biophysical Signatures of Monoclonal Antibodies -- Pharmacokinetics and Immunogenicity -- Impact of Fc Glycosylation on Monoclonal Antibody Effector Functions and Degradation by Proteases -- Immunogenicity Assessment of Antibody Therapeutics -- Armed Antibodies and New Classes of Antibodies -- Production of Monoclonal Antibodies in E. coli -- Recent Advancements in the Use of Antibody Drug Conjugates for Cancer Therapy -- Antibody Radiolabeling. |
| 520 ## - SUMMARY, ETC. |
|---|
| Summary, etc |
Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Medicine. |
|
|---|
| Topical term or geographic name as entry element |
Neurosciences. |
|
|---|
| Topical term or geographic name as entry element |
Toxicology. |
|
|---|
| Topical term or geographic name as entry element |
Biomedicine. |
|
|---|
| Topical term or geographic name as entry element |
Neurosciences. |
|
|---|
| Topical term or geographic name as entry element |
Pharmacology/Toxicology. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Gombotz, Wayne. |
| Relator term |
editor. |
|
|---|
| Personal name |
Bechtold-Peters, Karoline. |
| Relator term |
editor. |
|
|---|
| Personal name |
Andya, James. |
| Relator term |
editor. |
| 710 2# - ADDED ENTRY--CORPORATE NAME |
|---|
| Corporate name or jurisdiction name as entry element |
SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY |
|---|
| Title |
Springer eBooks |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY |
|---|
| Display text |
Printed edition: |
| International Standard Book Number |
9780387766423 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Uniform Resource Identifier |
http://dx.doi.org/10.1007/978-0-387-76643-0 |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Item type |
E-Book |
