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From The CriticsReviewer: Eugene A Davidson, PhD (Georgetown University School of Medicine)
Description: This book covers enzymes currently in clinical use. The chapters are somewhat descriptive; each has a suitable bibliography.
Purpose: The goal is to provide an overview of enzymes in clinical use with a focus on recombinant production. Certain commonalities limit the scope of the volume although issues discussed are of interest to the commercial producer. Success in meeting stated goals is limited.
Audience: The target audience includes those in the industrial laboratory/production facility responsible for manufacturing materials of this type. The general principles of production of recombinant material for human use are of importance — hopefully, those already doing such work are well aware of them. The contributing authors are mainly from European pharmaceutical companies and presumably are knowledgeable in the area.
Features: Two introductory chapters, one an overview and one discussing enzyme engineering, are followed by a set of descriptions of current production of therapeutic enzymes. The enzyme engineering factor covers issues such as stability, improvement of interaction with inhibitors (by specific amino acid changes), the role of glycosylation stability problems etc. These are important considerations for production and efficacy, but it must be recognized that each protein product will have its own challenge in this arena. Thus, an enzyme destined for lysosomal function must have the proper glycosylation signal while one intended for extended lifetime may require attachment of polyethylene glycol. Each of the chapters dealing with specific enzymes (10 in all) describes challenges in production for human use of the particular product. Useful bibliographies accompany each chapter. There is a significant amount of repetition both in text and figures (how many photos of a fermenter are required?), indicative of common problems in production. Perhaps repetition in this area is valuable. A concluding chapter provides brief information on a variety of products not generally recombinant but still with clinical utility (streptokinase, hyaluronidase, lactase, for example).
Assessment: This is a book of limited use — the production staff will know the issues (or should). Each protein has its own characteristic problems and will require an individualized solution. Those not in production but rather in the academic arena will find instructive material here. The book suffers from repetition.