Novel Therapeutics from Modern Biotechnology: From Laboratory to Human Testing
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Overview
While addressing the particular problems associated with several classes of biotechnology products, this book also demonstrates that the principles are the same as in the development of small new chemical entities. It begins by studying FDA regulatory expectations for biotech products, before moving on to discuss general issues common to each class of biotech drug, such as proteins, peptides, and nucleic acids. The text deals with specific biotech drugs that have successfully made it into clinical trials, and each review is written by a renowned expert in the relevant fields.
Disc. regulatory environment; issues common to peptides, proteins & nucleic acids; clinical trials; quality systems.
Editorials
From The Critics
Reviewer: Thomas L. McDonald, PhD(University of Nebraska Medical Center)Description: This book is an overview of problems and issues confronted in developmental work related to the use of biologicals for therapeutic purposes. The topics and examples provided cover a broad range of common problems associated with biotechnology product development, but more importantly, the editors and contributors provide and document how these problems were approached and solved. The book is well referenced and indexed for ease in navigation.
Purpose: The purpose is to introduce basic, common problems and considerations that must be addressed in developing a "biotech" therapeutic prior to its entry into clinical trials. This book is an excellent resource, in particular with the litany of references that document approaches to solutions regarding biologicals as therapeutics.
Audience: The audience is not indicated by the editors, but from my point of view as a research scientist and president of a University Technology Licensing Corporation, I would have greatly benefited from the information provided here if it had been published ten years ago. I would consider this book a "must read" for scientists in applied research, graduate students, and all personnel in technology transfer/intellectual property offices.
Features: The editors provide an introductory overview of the problems that are associated with introducing biological material into a living being for a therapeutic benefit. Discussions of complex issues related to production, toxicity, immunogenicity, and targeted delivery are a highlight. Although the depth of discussion on each of the topics is somewhat limited, the contributors compensate by providing sufficient references for further reading. The subject index is well designed and very helpful in navigating through the text. I found several of the illustrations, in particular those in the chapter on "Formulation and Delivery of Nucleic Acids," useful.
Assessment: This is a wonderful blend of presenting the problems that must be addressed when considering the use of a biological product as a therapeutic, and strategic approaches that companies have used to solve them. The strategies exemplified here are beyond just mere examples as they create an awareness of confounding issues that would be useful resources to scientists performing basic research in related areas. Although I greatly enjoyed the content of the book, the price seems very high to me.