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.