Protein drugs come of age

Abstract

Recombinant Protein Drugs (Milestones in Drug Therapy Series)Edited by Peter Buckel. Birkhauser Verlag, 2001. 210 DM (x + 207 pages) ISBN 3 7643 5904 8The biotechnology revolution of the past 30 years has had a profound impact on the direction of pharmaceutical research and development. Advances in molecular biology and immunology permitted the description of diseases at the molecular level and provided new paradigms for rational drug development. In addition, these developments provided us with the tools for manipulation of biological macromolecules, such as proteins and nucleic acids, and their large-scale production as a new generation of drugs. However, the translation of the knowledge from ‘bench to bedside’ would have been difficult without the close partnership of academic laboratories with pharmaceutical industries and the emergence of new ‘University spin off’ companies. Success of these endeavors is most evident in the significant number of currently approved recombinant protein drugs (>30) and in the growing list of therapeutic proteins awaiting regulatory approval (>300).Recombinant Protein Drugs celebrates these advances by offering a historical perspective on selected advances in protein drug discovery and development. The chapters are organized into four sections: (1) pioneers and business; (2) first generation protein drugs; (3) proteins with new functions: protein engineering; and (4) further improvement of protein drugs. The first two chapters narrate the ‘pioneer stories’ of the development of recombinant interferons and hepatitis B vaccine. The excitement of the new beginnings is captured including the marriage of academia with industry, and the scientific challenges of the early days are also highlighted. The first-generation protein drugs are illustrated by three reviews on clotting factors, colony stimulating factors and tissue plasminogen activator. These reviews are comprehensive and cover basic sciences and clinical applications. The third section provides a glimpse of the current research on second-generation protein drugs with a review on immunokines (fusion proteins of cytokines with single-chain antibodies capable of binding tumor-associated antigens). The last section presents the challenges in protein drug delivery with discussions on two diverse approaches: protein formulation and gene delivery. Formulation of proteins in biodegradable polymers is a viable approach to enhance its stability and favor desirable pharmacokinetics. However, gene therapy approaches aimed at achieving expression of the therapeutic protein by the target cells present major hurdles that need to be overcome before they can be used in clinical applications.The book is well organized and well written. Its greatest strength as well as its unique feature is the historical perspectives presented by the pioneering scientists. It also provides an excellent sampling of currently approved therapeutic proteins and future challenges in protein drug development. Obviously this book is not meant to serve as a compendium on therapeutic proteins. In view of this, the topics of choice for the first two sections are justified. However, a broader coverage of current approaches in development of second-generation protein drugs and their delivery would have been more appropriate for the third and fourth sections. Despite this limitation, Recombinant Protein Drugs makes excellent reading for health professionals and biomedical researchers, especially for those interested in pharmaceutical biotechnology research.