Pharmaceutical Biotechnology
A Focus on Industrial Application

Pharmaceutical Biotechnology: A Focus on Industrial Application covers the development of new biopharmaceuticals as well as the improvement of those being produced. The main purpose is to provide background and concepts related to pharmaceutical biotechnology, together with an industrial perspective. This is a comprehensive text for undergraduates, graduates and academics in biochemistry, pharmacology and biopharmaceutics, as well as professionals working on the interdisciplinary field of pharmaceutical biotechnology. Written with educators in mind, this book provides teachers with background material to enhance their classes and offers students and other readers an easy-to-read text that examines the step-by-step stages of the development of new biopharmaceuticals.

Features:

• Discusses specific points of great current relevance in relation to new processes as well as traditional processes
• Addresses the main unitary operations used in the biopharmaceutical industry such as upstream and downstream
• Includes chapters that allow a broad evaluation of the production process

Dr. Adalberto Pessoa Jr. is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo and Visiting Senior Professor at King?s College London. He has experience in enzyme and fermentation technology and in the purification processes of biotechnological products such as liquid?liquid extraction, cross-flow filtration and chromatography of interest to the pharmaceutical and food industries.

Dr. Michele Vitolo is Full Professor at the School of Pharmaceutical Sciences of the University of São Paulo. He has experience in enzyme technology, in immobilization techniques (aiming the reuse of the biocatalyst) and in the operation of membrane reactors for obtaining biotechnological products of interest to the pharmaceutical, chemical and food industries.

Dr. Paul F. Long is Professor of Biotechnology at King's College London and Visiting International Research Professor at the University of São Paulo. He is a microbiologist by training and his research uses a combination of bioinformatics, laboratory and field studies to discover new medicines from nature, particularly from the marine environment.

Chapter 1 Fundamentals of Biotechnology........................................................................................................................ 1

Michele Vitolo

Chapter 2 Thermodynamics Applied to Biomolecules.................................................................................................... 29

Attilio Converti, Adalberto Pessoa Jr, Jônatas de Carvalho Silva, Rodrigo Lira de Oliveira, and

Tatiana Souza Porto

Chapter 3 Expression Systems for the Production of Therapeutic Recombinant Proteins...............................................43

Amanda Mizukami, Adalberto Pessoa Jr, and Kamilla Swiech

Chapter 4 Molecular Biology: Tools in Industrial Pharmaceutical Biotechnology..........................................................55

Marina Gabriel Fontes and Gisele Monteiro

Chapter 5 Molecular Biology Tools: Techniques and Enzymes.......................................................................................73

Marina Gabriel Fontes and Gisele Monteiro

Chapter 6 Bioinformatics Applied to the Development of Biomolecules of Pharmaceutical Interest.............................89

Renata Bannitz Fernandes, Carlos Alexandre Breyer, Leonardo Schultz da Silva, Pedro Henrique

Camargo Penna, Antônio Sérgio Kimus Braz, and Marcos Antonio de Oliveira

Chapter 7 Bioprocesses: Microorganisms and Culture Media.......................................................................................115

Ricardo Pinheiro de Souza Oliveira and Adalberto Pessoa Jr

Chapter 8 Sterilization in Pharmaceutical Biotechnology..............................................................................................133

Valéria C. Santos-Ebinuma, Fernanda de Oliveira, Nathalia V. Veríssimo, Jorge F. B. Pereira, and

Adalberto Pessoa Jr

Chapter 9 Kinetics of Cell Cultivation............................................................................................................................147

Aldo Tonso, Adalberto Pessoa Jr, and Michele Vitolo

Chapter 10 Bioreactors: Modes of Operation...................................................................................................................157

Inês C. Roberto, Adalberto Pessoa Jr, and Aldo Tonso

Chapter 11 Agitation and Aeration: Oxygen Transfer and Cell Respiration....................................................................181

Aldo Tonso, Thiago Olitta Basso, Adalberto Pessoa Jr, and Ricardo Pinheiro de Souza Oliveira

Chapter 12 Mammalian Cell Culture Technology...........................................................................................................195

Patrícia Barros dos Santos, Patrícia Léo, Ricardo Pinheiro de Souza Oliveira, and

Marco Antonio Stephano

Chapter 13 Purification Process of Biomolecules............................................................................................................ 225

Adalberto Pessoa Jr and Beatriz Vahan Kilikian

Chapter 14 Lipopolysaccharides: Methods of Quantification and Removal from Biotechnological Products................239

André M. Lopes, Jorge F. B. Pereira, João V. D. Molino, Felipe R. Lourenço, and Adalberto Pessoa-Jr

Chapter 15 Enzymes: The Catalytic Proteins...................................................................................................................257

Michele Vitolo

Chapter 16 Enzymes as Drugs and Medicines................................................................................................................ 265

Carlota de Oliveira Rangel-Yagui and Michele Vitolo

Chapter 17 Aspects of the Immobilization Technique.....................................................................................................273

Michele Vitolo

Chapter 18 Biomolecules in Analytical Methods............................................................................................................ 287

João Henrique Picado Madalena Santos, Carlos Miguel Nóbrega Mendonça,

Francislene Andréia Hasmann, and Adalberto Pessoa Jr

Chapter 19 Nanotechnology and Biopharmaceuticals..................................................................................................... 299

Alexsandra Conceição Apolinário, Valker Araujo Feitosa, João Henrique Picado Madalena Santos,

and Carlota de Oliveira Rangel-Yagui

Chapter 20 Biosafety Applied in Pharmaceutical and Biotechnological Processes.........................................................313

Camila Manoel Crnkovic, Celso Pereira Caricati, Ricardo Pinheiro de Souza Oliveira, and

Marco Antonio Stephano

Chapter 21 Pharmaceutical Quality System for Biotechnology Products........................................................................325

Laura de Oliveira Nascimento, Francisco Vitor Santos da Silva, and Marco Antonio Stephano

Chapter 22 Techno-Economic Evaluation of Biotechnological Processes and Pharmacoeconomic Analysis................355

Rafael da Gama Ferreira, Nicola Sgrignoli Fuganholi, Larissa Pereira Brumano,

Adriano Rodrigues Azzoni, and Sindelia Freitas

Chapter 23 Perspectives for Pharmaceutical Biotechnology............................................................................................369

Michele Vitolo

Dr. Adalberto Pessoa Jr., Full professor at the School of Pharmaceutical Sciences of the University of São Paulo and Visiting Senior Professor at King’s College London. He has experience in enzyme and fermentation technology and in the purification processes of biotechnological products, such as liquid-liquid extraction, cross-flow filtration and chromatography of interest to the pharmaceutical and food industries.

Dr. Michele Vitolo, Full professor at the School of Pharmaceutical Sciences of the University of São Paulo. He has experience in enzyme technology, in immobilization techniques (aiming the reuse of the biocatalyst), and in the operation of membrane reactors for obtaining biotechnological products of interest to the pharmaceutical, Chemical, and food industries. michenzi@usp.br

Dr. Paul Long is Professor of Biotechnology at King's College London and Visiting International Research Professor at the University of São Paulo. Prof Long is a microbiologist by training and his research uses a combination of bioinformatics, laboratory and field studies to discover new medicines from nature, particularly from the marine environment.