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Commercial production of monoclonal antibodies: A guide for scale-up
Journal of Immunological Methods, 107 (1988) 291-292
291
Elsevier JIM 04699
Book reviews
Commercial Production of Monoclonal Antibodies: A Guide for Scale-Up,
Seaver, S.S. (Ed.),
327 pp. Marcel Dekker, New York, 1987. ISBN 0-8247-7765-4 The success of monoclonal antibody technology in the Health Care and other fields has resulted in an inevitable demand for relatively large amounts of highly purified antibody free of virus and endotoxin contaminants. This book deals with many of the problems commercial companies have to face when scaling up the production of monoclonal antibodies for both diagnostic and therapeutic use.
The book consists of 14 chapters written almost exclusively by individuals working in industry. The book is divided into three main sections dealing with: (1) factors to be considered before scale-up, e.g., media formulation, choice of culture system, etc.; (2) the production of monoclonal antibodies in ascites and by large scale in vitro systems including suspension culture and immobilised cell technologies; (3) the downstream processing of monoclonal antibodies. It also contains a useful appendix going into further detail with respect to antibody purification, etc. In a multi-author book of this kind there is inevitable variation both with respect to presentation and content. Some chapters are limited in that they deal with either a restricted number of cell lines or other variables. The book however contains a number of contributions which the reviewer found extremely useful. These included chapters on factors influencing monoclonal anti-
body production in mouse ascitic fluid, the design and operation of a medium scale facility for producing antibodies to good manufacturing practise standards, the operation of hollow fibre and micro-encapsulation technology and the development of a novel chromatographic matrix for the purification of monoclonal antibodies. Unfortunately there are no contributions from a number of companies who have considerable experience in the large-scale production of monoclonal antibodies in air-lift fermenters and other systems. However as the editor stresses in the preface a number of people who were invited to contribute were unable to do so for commercial or other reasons. As the editor also stresses in the preface the book will not provide the reader with information on the best system for cost effective scale-up. While the reviewer would concur with this conclusion, he feels the book would have been improved by the inclusion of a general chapter dealing with the various techniques currently used in the large scale production of monoclonal antibodies and their downstream processing together with the advantages and disadvantages of any of these procedures. Furthermore inclusion in the appendices of the relevant regulatory requirements of the FDA and other non-U.S.A, regulatory bodies, would have been useful. Nevertheless in spite of these comments the editor is to be commended for addressing the problem of the commercial production of monoclonal antibodies. KEITH JAMES
JIM 04710
Cotman, C.W., Brinton, R.E., Galaburda, A., McEwen, B. and Schneider, D.M. (Eds.), The Neuro-lmmune-Endocrine Connection, x + 150 pp., illus. Raven Press, New York, 1987. $54.00, ISBN 0-88167-260-2
Jankovir, B.D., Markovi6, B.M. and Spector, N.H. (Eds.), Neuroimmune Interactions, 756 pp., soft cover. The New York Academy of Sciences, New York, 1987 (Ann. N.Y. Acad. Sci. Vol. 496). ISBN 0-89766-388-8
0022-1759/88/$03.50 ~ 1988 El~vier Science Publishers B.V. (Biomedical Division)
291
Elsevier JIM 04699
Book reviews
Commercial Production of Monoclonal Antibodies: A Guide for Scale-Up,
Seaver, S.S. (Ed.),
327 pp. Marcel Dekker, New York, 1987. ISBN 0-8247-7765-4 The success of monoclonal antibody technology in the Health Care and other fields has resulted in an inevitable demand for relatively large amounts of highly purified antibody free of virus and endotoxin contaminants. This book deals with many of the problems commercial companies have to face when scaling up the production of monoclonal antibodies for both diagnostic and therapeutic use.
The book consists of 14 chapters written almost exclusively by individuals working in industry. The book is divided into three main sections dealing with: (1) factors to be considered before scale-up, e.g., media formulation, choice of culture system, etc.; (2) the production of monoclonal antibodies in ascites and by large scale in vitro systems including suspension culture and immobilised cell technologies; (3) the downstream processing of monoclonal antibodies. It also contains a useful appendix going into further detail with respect to antibody purification, etc. In a multi-author book of this kind there is inevitable variation both with respect to presentation and content. Some chapters are limited in that they deal with either a restricted number of cell lines or other variables. The book however contains a number of contributions which the reviewer found extremely useful. These included chapters on factors influencing monoclonal anti-
body production in mouse ascitic fluid, the design and operation of a medium scale facility for producing antibodies to good manufacturing practise standards, the operation of hollow fibre and micro-encapsulation technology and the development of a novel chromatographic matrix for the purification of monoclonal antibodies. Unfortunately there are no contributions from a number of companies who have considerable experience in the large-scale production of monoclonal antibodies in air-lift fermenters and other systems. However as the editor stresses in the preface a number of people who were invited to contribute were unable to do so for commercial or other reasons. As the editor also stresses in the preface the book will not provide the reader with information on the best system for cost effective scale-up. While the reviewer would concur with this conclusion, he feels the book would have been improved by the inclusion of a general chapter dealing with the various techniques currently used in the large scale production of monoclonal antibodies and their downstream processing together with the advantages and disadvantages of any of these procedures. Furthermore inclusion in the appendices of the relevant regulatory requirements of the FDA and other non-U.S.A, regulatory bodies, would have been useful. Nevertheless in spite of these comments the editor is to be commended for addressing the problem of the commercial production of monoclonal antibodies. KEITH JAMES
JIM 04710
Cotman, C.W., Brinton, R.E., Galaburda, A., McEwen, B. and Schneider, D.M. (Eds.), The Neuro-lmmune-Endocrine Connection, x + 150 pp., illus. Raven Press, New York, 1987. $54.00, ISBN 0-88167-260-2
Jankovir, B.D., Markovi6, B.M. and Spector, N.H. (Eds.), Neuroimmune Interactions, 756 pp., soft cover. The New York Academy of Sciences, New York, 1987 (Ann. N.Y. Acad. Sci. Vol. 496). ISBN 0-89766-388-8
0022-1759/88/$03.50 ~ 1988 El~vier Science Publishers B.V. (Biomedical Division)