handbook of pharmaceutical biotechnology

8/6/2019 Handbook of Pharmaceutical Biotechnology

1/6


2/6

CONTENTS

Preface xix

1.1 From G ene to Prod uct: Th e Ad vanta ge of IntegrativeBiotechnology 1Frank-Ranter Schmidt

1.2 Sequencing the Hum an G en om e: W as It W orth It? 53Eugene Z abarovskv

1.3 Ov erview: Differentiating Issues in the De velop m ent ofM acrom olecules Com pared with Small M olecules 89Giinther Blaich, Bernd Janssen, Gregory Roth, and Jochen Salfeld

1.4 Integrated Dev elopm ent of Glyco biologics: From Discoveryto Applications in the Design of Nanoparticular DrugDe livery Systems 125Christine Va uthier, Isabelle Bertholon, and Denis Laba rre

1.5 R & D Paradigm Shift and Bil l ion-D ollar Biologies 161Krishan Maggon

2 From Defining Bioinformatics and Pharmacogenomics toDeveloping Information-Based Medicine and Pharmacotypingin He alth Care 201loannis S. Vizirianakis

3.1 Toxicogenom ics 229Mary Jane Cunningham and Mrinal Shah


3/6

xiv CONTENTS3.2 Preclinical Pharm acokinetics 253

Donald E. Mager and Murali Ramanthan3.3 Strategies for the Cytosolic De livery of M acrom olecules:

An Overview 279Aravind Asokan, Roland Cheung, and Moo J. Cho4.1 Basic Issues in the Manufacture of M acrom oleucles 297

Corinne Lengsfeld and Thomas Anchordoquy4.2 Process Validation for Biopharmaceuticals 319

Beth Junker4.3 Stability Asse ssment and Formulation Characterization 371Albert H.L. Chow, Henry H.Y. Tong, and Ying Zheng4.4 Protein Posttranslational M odification: A Potential Targetin Pharmaceutical Dev elopm ent 417

M.D. Mostaqul Huq and Li-Na Wei4.5 PEG ylation: Camouflage of Proteins, Cells, and NanoparticlesAgainst Recognition by the Body's Defen se M echanism 443

Yong Woo Cho, Jae Hyung Park, Ji Sun Park, and Kinam Park4.6 Unexpected Benefits of a Form ulation: Case Study withErythropoetin 463

David Keast5.1 Capillary Separation Techniques 469

Dong Hee Na and Kang Choon Lee5.2 Pharmaceutical Bioassay 511

Jun Li, Ming Zhao, and Shiqi Peng5.3 Analytical Considerations for Immunoassays forMacromolecules 573

Marian Kelley and Binodh DeSilva5.4 Chromatography-Based Separation of Proteins, Peptides,and Am ino Acids 585

Jan Moebius, Remco Swart, and Albert Sickman5.5 Bioanalytical M ethod Validation for M acromolecules 611Gerhard K.E. Scriba5.6 Microarrays in Drug Discovery and Development 633

Krishnanand D. Kumble and Sarita Kumble


4/6

CONTENTS xv5.7 Ge netic Markers and Gen otyping An alyse s for Ge netic

Dise ase Studies 661Anne E. Kwitek and Michael Olivier

6 .1 Prote ins : Horm ones , Enzym es , and Monoc lona l \Ant ibod iesBackground 691Wayne Materi, Zoltan Gombo s, and David S. Wishart

6.2 Formulation and Delivery Issues of Therapeu tic Proteins 737Sathy V . Balu-Iyer, Razvan D. M iclea, and Vivek S. Purohit

6.3 Phar ma cokinetics 757Nobuhito Shibata, Yukato ho, and Kanji Takada

6.4 Im mu nogenicity of Thera peutic Proteins 815Suzanne Hermeling, Daan J.A. Cromm elin, H uub Schellekens,and Wim Jiskoot

6.5 De velopm ent and Characterization of High-AffinityAn ti-Topotecan IgG and Fab Fragm ents 835Jin C hen and Joseph P. Balthasar

6.6 Recom binant An t ibodies for Pathogen De tect ion andImmunotherapy 851Nicholas J.Pokorny, Jeanine I. Boulter-Bitzer, J. Chris Hall,Jack T. Trevors, and Hung Lee

6.7 Th e Radiopharm aceutical Science of M onoclona l A ntib od iesand Peptides for Imaging and Targeted in situ Radiotherapy ofMal ignancies 883Raymond M. Reilly

7.1 G en e Thera py Basic Principles and the Road from Ben ch toBedside 943Gabor M. Rubanyi

7.2 Plasmid D N A and M essenger R N A for Therapy 971Steve Pascolo

7.3 Form ulations and Delivery Lim itations of Nu cleic-Ac id-Ba sedTherapies 1013Tatiana Segura

7.4 Phar m acokinetics of Nu cleic-Ac id-Ba sed Thera peutics 1061John C . Schmitz, Aleksandra Pandyra, James Koropatnick,and Randal. W. Berg


5/6

xvi CONTENTS7.5 Case Stud ies Dev elopm ent of Ol igo nuc leot ides 1087

Ezharul Hoque Chowdhury and Toshihiro Akaike7.6 R N A Interference: The Next Gen e-Targeted M edicine 1109

Andrew V. Oleinikov and Matthew D. Gray7.7 Del ivery Systems for Pe pt ides /Ol igo nuc leot ides and

Lipophi l ic Nu cleoside An alog s 1149R.A. Schwendener and Herbert Schott

8.1 Grow th Factors and Cy tok ines 1173Mandeep K. Mann and Brian E. Cairns

8.2 Growth Factors , Cy tokines , and Ch em okin es: Form ulat ion,Del ivery, and Pharm acokinet ics 1197Heping Cao and Rui Lin

9 Prote in Engineer ing wi th Non coded Am ino Acid s: Appl i ca t ionsto Hirudin 1225Vincenzo De F ilippis

10.1 Pro duction and Purif ication of Ad eno viru s Vec tors for G en eTherapy 1261D.M.F. Prazeres and J.A.L. Santos

10.2 Asse ssing Ge ne Therapy by M olecular Imaging 1297Pascal Delepine and Claude Ferec

11 Over view of Stem and Artif icial Cells 1313Alejandro Soto-Gutierrez, Nalu Navarro-Alvarez,Jorge David Rivas-Carrillo, and Naoya Kobayashi

12.1 Reg ulat ion of Sm al l -Molecule Dru gs Versus Biologica lsVersus Biotech Produ cts 1373Maria de los Angeles Cortes Castillo and Jose Luis Di F abio

12.2 Intel lectual Property and Biotec hno logy 1391Tania Bubela and Karen Lynne Durell

12.3 Com parabi li ty Studies for Later-G enerat ion Produ ctsPlant-Made Pharm aceut icals 1433Patrick A. Stewart

12.4 Biosim ilars 1453H. Schellekens, W. Jiskoot, and D.J.A. Crommelin


6/6

CONTENTS xvi i13.1 The Prom ise of Individualized Therapy 1463

Michael Oettel13.2 Enh anced Proteom ic Ana lysis by HP LC Prefractionation 1491

Pierre C. Havugimana, P eter Wong, and Andrew Emili13.3 A n Overview of M etabonom ics Techniques and App lications 1503

John C. Lindon13.4 Bioterrorism 1525

Dany Shoham

Index 1653

handbook of pharmaceutical biotechnology

Documents