**Background**

Finally, we acknowledge the authors' participation in helping us to complete this book. Many professionals contributed their efforts, knowledge, and experiences to this publica‐

cooperation and harmonization, and the presentation of research achievement. The readers will be able to read many constructive, insightful, and significant articles in the book. We wish that the researchers' accomplishments can be put into practice and improve the health

a platform to promote the sharing of experiences, the international

**Ming-Kung Yeh, PhD** School of Pharmacy

**Yuan-Chuan Chen, PhD**

University of California Berkeley, CA, USA

Taipei, Taiwan

National Defense Medical Center

Program in Comparative Biochemistry

tion. This book provides

VIII Preface

of people worldwide in the future.

**Chapter 1**

**Provisional chapter**

**Introductory Chapter: Biopharmaceuticals**

**Introductory Chapter: Biopharmaceuticals**

DOI: 10.5772/intechopen.79194

A biopharmaceutical (biological or biologic), which consists of sugars, proteins, nucleic acids, living cells, or tissues, is a medicinal product manufactured in extracted or semi-synthesized from biological sources like humans, animals, or microorganisms. Different from traditional drugs synthesized from chemical processes, the majority of biopharmaceutical products are derived from biological processes including the extraction from living systems or the production by recombinant DNA technologies (**Table 1**). Transgenic organisms, especially plants, animals, or microorganisms that have been genetically modified, are potentially used to pro-

The recombinant human insulin (trade name "Humulin") was the first biopharmaceutical approved for human therapeutic uses and marketing in 1982. Currently, biopharmaceuticals have been extensively used as therapeutic agents such as vaccines, whole blood (or blood components), immunosera, antigens, hormones, cytokines, enzymes, allergenics, cell therapies, gene therapies, tissues, monoclonal antibodies, and products derived from recombinant DNA, etc. For example, vaccines are used to prevent infectious diseases and some cancers; cell- and gene-based biopharmaceuticals are applied to treat a variety of diseases for which

The European Medicines Agency (EMA) uses the specific term "advanced therapy medicinal products (ATMPs)" to refer to human medicines that are based on cells, genes, or tissue engineering. Cell therapy products (CTPs) are biomedicines containing cells/tissues that have been manipulated to change their biological characteristics, and these cells/tissues can be used to treat, prevent, or diagnose diseases [1]. Gene therapy products (GTPs) are therapeutic agents to make genetic improvement through the repair, deletion, insertion, or substitution of mutated genes or site-specific modifications for target therapies [2]. Tissue engineering is the application of a combination of cell, engineering, and material methods, and suitable factors

> © 2016 The Author(s). Licensee InTech. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

© 2018 The Author(s). Licensee IntechOpen. This chapter is distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/3.0), which permits unrestricted use,

distribution, and reproduction in any medium, provided the original work is properly cited.

Yuan-Chuan Chen and Ming-Kung Yeh

Yuan-Chuan Chen and Ming-Kung Yeh

http://dx.doi.org/10.5772/intechopen.79194

**1. Introduction**

duce biopharmaceuticals.

no other drugs or medical devices are available.

Additional information is available at the end of the chapter

Additional information is available at the end of the chapter

#### **Introductory Chapter: Biopharmaceuticals Introductory Chapter: Biopharmaceuticals**

DOI: 10.5772/intechopen.79194

Yuan-Chuan Chen and Ming-Kung Yeh Yuan-Chuan Chen and Ming-Kung Yeh

Additional information is available at the end of the chapter Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/intechopen.79194
