Contents

#### **Preface XI**



### **Section 5 Manufacture 85**

Chapter 5 **Development, Engineering and Biological Characterization of Stirred Tank Bioreactors 87** Cedric Schirmer, Thomas Nussbaumer, Reto Schöb, Ralf Pörtner, Regine Eibl and Dieter Eibl

#### **Section 6 Regulation 109**

Chapter 6 **Scientific and Regulatory Perspective on Monoclonal Antibody Biosimilars 111**

Po-Chih Wu, Yi-Chen Yang, Der-Yuan Wang and Hwei-Fang Cheng

Preface

offer this opportunity to us.

biopharmaceuticals.

Health is priceless and to be free from illness is considered a basic human right. Along with the advance of biomedical science and the improvement of public health, many previously incorrigible diseases can be cured or even eradicated now and the life expectancy is definite‐ ly extended. Translational medicine linking the basic research and clinical applications pro‐ motes the discovery of novel medicines, particularly biopharmaceuticals. Clearly, biopharmaceuticals play an important role in the exciting development and progress of medicines. For recent studies, innovative biopharmaceuticals are developing rapidly and have opened a new era for human therapy. Many researchers are involved in the related research for the development of biopharmaceuticals and have achieved significant results. Our team has also been working on the same topics for years and has achieved some prom‐ ising results. We have long hoped to summarize the research achievement of biopharma‐ ceuticals in a book. Here, we are grateful for IntechOpen's generosity and enthusiasm to

Biopharmaceuticals, which consist of sugars, proteins, nucleic acids, living cells, or tissues, are medicinal products manufactured from extracted or semisynthesized biological sources like humans, animals, or microorganisms. 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, products derived from recombinant DNA, etc. For example, vac‐ cines are used to prevent infectious diseases and some cancers; gene-based and cellular bio‐ pharmaceuticals are applied to treat a variety of diseases for which no other drugs or medical devices are available. However, the research and development (R&D) of biophar‐ maceuticals is typically difficult, expensive, and time-consuming. Biopharmaceuticals can be produced in microbial cells, animal cell lines, plant cell cultures, or bioreactors of various configurations. The cost of production (low-volume containers and high-purity products are essential) and microbial contamination are the two major concerns during the production process. Despite this, more and more biopharmaceuticals have been successfully developed and marketed through the introduction of new biotechnologies, production approaches, and delivery tools. The inventors who discover a new biopharmaceutical usually apply for a pat‐ ent (or license) to have the grant for the exclusive manufacturing right, because this is a method by which the inventors can recover their investment cost. It is crucial to establish a strict but flexible framework of regulation for investigating, applying, and patenting bio‐ pharmaceuticals. Therefore, the interdisciplinary collaboration including researchers, regu‐ lators, funders, and manufacturers should be encouraged for the successful development of
