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Contents Biomaterials & Medical Devices ........................3 Bioprocessing........................................................5 Nanobiotechnology ..........................................6 Biotechnology ................................................10 Medicine & Biology ........................................14 Page 21

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Drug Discovery & Delivery ............................16 Clinical Trials ..................................................19 Industry Applications ......................................20

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Biomaterials & Medical Devices

New!

Biological and Biomedical Coatings Handbook, Two-Volume Set Edited by

Sam Zhang Nanyang Technological University, Singapore

A Simplified Guide to One of the Hottest Topics in Nano… Written in a versatile, contemporary style that will benefit both novice and expert alike, Biological and Biomedical Coatings Handbook, Two-Volume Set explores the state of the art in the development and implementation of advanced thin films and coatings in the biological field. Providing up-to-date figures, tables, plots, and images, this set features contributions from top global experts to covers advances in design and performance of biological and biomedical coatings for a vast array of material types. It also details the novel techniques used in the manufacture and testing of their clinical application, particularly in the field of regenerative medicine.

SAVE WHEN YOU BUY THE SET! Catalog no. K11126, April 2011, 976 pp., ISBN: 978-1-4398-2125-1 , $249.95 / £159.00

Individual volumes include:

Processing and Characterization An exploration of the fundamentals elements of coatings, the first volume, Processing and Characterization, addresses: • Synthesis, fabrication, and characterization of nanocoatings • The sol-gel method and electrophoretic deposition • Thermal and plasma spraying • Hydroxyapatite and organically modified coatings • Bioceramics and bioactive glass-based coatings • Hydrothermal crystallization and self-healing effects • Physical and chemical vapor deposition • Layered assembled polyelectrolyte films

Contents (abridged)

Applications Building on the theoretical and methodological fundamentals of coatings as presented in the first volume, Applications covers: • Biological/biomedical implants and other applications of carbon-based materials • Control of drug release from coatings • MIcrofluidic and biosensing/bioactive coatings and applications • Surfaces and coatings of orthopedic, dental, and other implants • Sol–gel-derived hydroxyapatite coatings on metallic implants • Impedance spectroscopy

Contents (abridged)

Bonelike Mineral and Organically Modified Bonelike Mineral Coatings Synthesis and Characterization of Hydroxyapatite Nanocoatings by Sol–Gel Method for Clinical Applications Hydroxyapatite and Other Biomedical Coatings by Electrophoretic Deposition

Sol-Gel Derived Hydroxyapatite Coatings on Metallic Implants: Characterization, In Vitro and In Vivo Analysis Amorphous Carbon Coatings for Biological Applications Biomedical Applications of Carbon-Based Materials Impedance Spectroscopy on Carbon-Based Materials for Biological Application

Catalog no. K12269, April 2011, 456 pp. ISBN: 978-1-4398-4995-8, $139.95 / £89.00

Catalog no. K12270, April 2011, 520 pp. ISBN: 978-1-4398-4996-5, $139.95 / £89.00

For more information and complete contents, visit www.crcpress.com

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Biomaterials & Medical Devices New!

Porous Media Biomaterials A Nano Approach

Applications in Biological Systems and Biotechnology

Seeram Ramakrishna, Murugan Ramalingam, T.S. Sampath Kumar, and Winston O. Soboyejo

Edited by

Written from a multidisciplinary point of view that integrates aspects of materials science and engineering, nanotechnology, bioengineering, and biosciences, this book explores biomaterials and scientifically plausible scenarios in which nanotechnology is likely to play a significant role. The authors examine basic concepts, processing methodologies, and techniques involved in the preparation and characterization of nanobiomaterials specific to biomedical applications. Covering everything from the historical development of biomaterials to cutting-edge advances, the text describes how basic nano concepts are applied to the processing of novel nanobiomaterials, including metals and alloys. With its illustrative presentation of application examples and exercises, this text offers a solid framework for understanding present and future trends of biomaterials in human healthcare systems.

Presenting state-of-the-art research advancements, this volume explores innovative approaches to effectively apply existing porous media technologies to biomedical applications. In each peer-reviewed chapter, world-class scientists and engineers address significant problems and discuss exciting research in biological systems. They cover various transport processes, mechanical behavior, and material properties of biological tissues from a porous media point of view. The book also presents pertinent aspects of experimental work and numerical techniques and discusses the modeling of several phenomena, including flow changes in cerebral aneurysms, biomass growth, marine systems, and tissue homeostasis and repair.

Features • Discusses materials used for biomedical applications, including tissue engineering and drug delivery • Describes the biological and environmental effects of nanomaterials • Presents useful data tables and case studies that demonstrate the vital role of nanobiomaterials

Contents Overview of Biomaterials Basics of Human Biology Degradation and Corrosion of Biomaterials Failure and Tribology of Biomaterials Nanoscale Phenomena Metallic Biomaterials Ceramic Biomaterials Polymeric Biomaterials Composite Biomaterials Nanobiomaterials for Tissue Engineering Catalog no. 47817, 2010, 372 pp. ISBN: 978-1-4200-4781-3, $99.95 / £69.99

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Kambiz Vafai University of California, Riverside, USA

Features • Explores state-of-the-art research advances in the application of porous media to biological systems and biotechnology • Presents pertinent aspects of experimental work and numerical techniques • Discusses the modeling of several phenomena, including flow changes in cerebral aneurysms, biomass growth, marine systems, and tissue homeostasis and repair

Contents (abridged) A General Set of Bioheat Equations Based on the Volume Averaging Theory. Mathematical Models of Mass Transfer in Tissue for Molecular Medicine with Reversible Electroporation. Hydrodynamics in Porous Media with Applications to Tissue Engineering. Biomedical Implications of the Porosity of Microbial Biofilms. Influence of Biofilms on Porous Media Hydrodynamics. Using Porous Media Theory to Determine the Coil Volume Needed to Arrest Flow in Brain Aneurysms. Lagrangian Particle Methods for Biological Systems. Passive Mass Transport Processes in Cellular Membranes and Their Biophysical Implications. Catalog no. 65416, January 2011, 632 pp. ISBN: 978-1-4200-6541-1, $149.95 / £95.00

New and Noteworthy Books in Biotechnology from CRC Press


MBCBT31_5.5x8.5_MC_J:MBCBT31 5.5x8.5 MC_J 3/21/11 5:20 PM Page 5

Bioprocessing

The Metabolic Pathway Engineering Handbook, Two-Volume Set Christina Smolke Stanford University, California, USA

Christina Smolke is regarded as one of the most brilliant minds in biomedical engineering, having developed a novel way to churn out large quantities of drugs from genetically modified brewer’s yeast. With this handbook, she assembles pioneering scientists from dozens of disciplines to provide a complete record of accomplishment in metabolic pathway engineering. Filled with cutting-edge research and analysis, this work is an invaluable resource for those seeking to add their own contributions. Organized by topic, this 3000-page reference is available as two volumes that can be purchased individually or as a set.

Contents Cellular Metabolism. Balances and Reaction Models. Regulation and Metabolic Pathways. Modeling Tools for Metabolic Engineering. Developing Appropriate Hosts for Metabolic Engineering. Evolutionary Tools in Metabolic Engineering. Gene Expression Tools for Metabolic Pathway Engineering. Applications of Emerging Technologies to Metabolic Engineering. Future Prospects in Metabolic Engineering.

SAVE WHEN YOU BUY THE SET! Catalog no. 3923, January 2010, 1259 pp. ISBN: 978-0-8493-3923-3, $249.95 / £159.00

Individual volumes include:

Fundamentals

Tool and Applications

A wide-ranging overview of the field and its future, this volume explores subjects including:

This volume delves into evolutionary tools, including those associated with gene expression for metabolic pathway engineering. It covers:

• Cellular metabolism, including transport processes inside the cell

• Applications of emerging technologies

• Energy generating reactions

• Research on genome-wide technologies

• Rare metabolic conversions

• DNA and phenotypic microarrays

• Balances and reaction models

• Proteomics tools for experimentally determining flux through pathways

• Regulation of metabolic pathways • Genome scale and multi-scale modeling tools

• Emerging applications for producing fine chemicals, drugs, and alternative fuels

• Development of appropriate hosts, including the use of E.coli and other bacteria

Catalog no. 77651, 2010, 581 pp. ISBN: 978-1-4200-7765-0, $164.95 / £102.00

Catalog no. K10164, 2010, 678 pp. ISBN: 978-1-4398-0296-0, $164.95 / £102.00

For more information and complete contents, visit www.crcpress.com

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Bioprocessing Macroporous Polymers Production Properties and Biotechnological/ Biomedical Applications Edited by

Bo Mattiasson and Igor Yu. Galeaev Lund University, Sweden

Ashok Kumar Indian Institute of Technology, Kampur

Macroporous polymers are rapidly becoming the material of choice for many tissue engineering, bioseparation, and bioprocessing applications. Using a systematically logical style to present information, this book addresses the production, characterization, and application of these polymers. It considers traditional methods of production, including phase separation polymerization, leaching, foaming, and double emulsion, as well as emerging methods such as cryogelation. The chapters also detail the various applications of macroporous gels—to separate biomolecules and cultivate mammalian cells in bioreactors, as well as for tissue engineering.

Features • Includes an abundance of illustrations and tables, as well as a four-page color insert • Summarizes recent research on preparation of macroporous cryogels via free-radical polymerization, presenting future perspectives • Describes different leaching techniques that have been used to fabricate porous polymer solids for biomedical applications • Provides an overview of the techniques used to characterize porous hydrogels, describing the potential and limitations of each particular method • Discusses ring opening polymerization of polyesters, scaffold fabrication techniques, and surface modification of polyester scaffolds to improve cell culture properties • Addresses selection of a suitable bioreactor for a given scaffold

Nanobiotechnology Particulate Systems in Nano- and Biotechnologies Edited by

Wolfgang Sigmund, Hassan El-Shall, Dinesh O. Shah, and Brij. M. Moudgil University of Florida, Gainesville, USA

Addressing advancements in absorbed films and particle technology as a foundation for nano and biotechnology innovations, this book delves into important topics in this area and summarizes developments that have occurred worldwide during the past decade. Experts from European, Australian, Asian, and North American research centers—including the National Science Foundation’s Engineering Research Center for Particle Science and Technology—offer critical perspectives relative to each of their specific research areas. They also examine the status of technology and define the challenges that must be addressed by future investigations.

Features • Surveys relevant technologies, offering critical perspectives on the synthesis, processing, and characterization of particulate systems for nano- and biotechnology • Assesses developments in absorbed films and particulate systems and technology • Discusses FloDots, functionalized magnetite nanoparticles, and zero-valent iron nanoparticles for abatement of environmental pollutants

Contents (abridged)

Macroporous Gels: A Theoretical Overview. Production of Macroporous Polymeric Materials by Phase Separation Polymerization. Production and Properties of Poly(Vinyl Alcohol) Cryogels.

Particle Technology—Then and Now—A Perspective. The Production of Nanoparticles, the "Top-Down" Approach, with the Emphasis on Aerosol Routes, Especially Electrohydrodynamic Atomization. Use of Self-Assembled Surfactants for Nanomaterials Synthesis. Synthesis and Engineering of Polymeric Latex Particles for Hemodialysis: Part I—A Review. Synthesis and Engineering of Polymeric Latex Particles for Hemodialysis: Part II—An Experimental Study. Product Engineering of Nanoscaled Materials. Surface Engineering Quantum Dots at the AirWater Interface. Fundamental Forces in Powder Flow. Characterization of Pharmaceutical Aerosols and Dry Powder Inhalers for Pulmonary Drug Delivery.

Catalog no. 84615, 2010, 525 pp. ISBN: 978-1-4200-8461-0, $133.95 / £85.00

Catalog no. 7436, 2009, 385 pp. ISBN: 978-0-8493-7436-4, $162.95 / £102.00

Contents (abridged)

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New and Noteworthy Books in Biotechnology from CRC Press


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Nanobiotechnology New! Coming Soon!

Bionanotechnology II Global Prospects Edited by

David E.. Reisner The Nano Group, Inc., Farmington, Connecticut, USA

A wide-ranging global perspective of this rapidly evolving bionanotechnology sector, this book updates coverage of the biological processes and structures being used to develop technologies that can improve medicine and agriculture. Topics include: self-assembly, cell detection strategies, and medical diagnostics, labeling, and imaging, as well as development of antiviral therapeutics, drug delivery, tissue engineering, and theragnostic nanoparticles that can diagnose, treat, and monitor diseases. Discussing the formation of crucial one-dimensional nanostructures that can lead to advances such as development of novel nanowires and other devices, this book navigates our newfound ability to insinuate our own design skills at the nanoscale level in living systems. Catalog no. K10254, July 2011, c. 472 pp. ISBN: 978-1-4398-0463-6, $99.95 / £63.99

Applied Optics Fundamentals and Device Applications Nano, MOEMS, and Biotechnology Mark A. Mentzer US Army Research Laboratory, Aberdeen Proving Ground, Maryland, USA

Insights into Optical MEMS —from a Top Government Researcher Providing an interdisciplinary look at optics technology, this book investigates the connection between nanotechnology, MOEMS, and biotechnology. It covers fundamental relationships and system applications and includes design examples and numerous useful references. The author discusses emerging technologies augmented with MEMS, MOEMS, nanotechnology, biotechnology, fiber optic sensing, integrated optics, optical computing and signal processing, integrated optics, and electrooptics. He uses case studies to provide a comprehensive understanding of the way in which emerging optics technologies are applied in the marketplace.

Features

Bionanotechnology Global Prospects Edited by

David E. Reisner The Nano Group, Inc., Farmington, Connecticut, USA

This first edition gives the modern biomedical engineer a deeper understanding of this massive field. Featuring chapters drawn from the third edition of the bestselling Handbook of Biomedical Engineering as well as other sources, this book surveys the research and activities that are shaping this burgeoning field. Covering both technical and non-technical areas, the book discusses the role of nanotechnology in novel medical devices, bioanalytical technologies, and nanobiomaterials, as well as intellectual property issues unique to this area. Catalog no. 7528, 2009, 368 pp. ISBN: 978-0-8493-7528-6, $97.95 / £61.99

• Draws connections between nanotechnology, MOEMS, and biotechnology • Uses case studies, as well as problems with solutions, to provide a comprehensive understanding of the way in which emerging optics technologies are applied in the marketplace • Presents a host of application examples, fabrication and manufacturing techniques, and testing methodologies

Contents Introduction to Convergent Disciplines in Optical Engineering: Nano, MOEMS, and Biotechnology. Electro-Optics. Acousto-Optics, Optical Computing, and Signal Processing. Fiber-Optic Sensors. Integrated Optics. Optical Diagnostics and Imaging. MEMS, MOEMS, Nano, and Bionanotechnologies. Catalog no. K11430, April 2011, 370 pp. ISBN: 978-1-4398-2906-6, $129.95 / £82.00

For more information and complete contents, visit www.crcpress.com

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Nanobiotechnology Coming Soon!

DNA Liquid-Crystalline Dispersions and Nanoconstructions

Coming Soon!

Yuri M. Yevdokimov, V.I. Salyanov, S.V. Semenov, and S.G. Skuridin

Edited by

With detailed coverage of DNA liquid crystals, this book explores the information presently available on the condensation of various forms of DNA. The authors present the practical applications of the peculiar properties of the liquidcrystalline state of nucleic acids. Showing how double-stranded nucleic acids represent an important tool for nanotechnology, the authors address modeling the state of the DNA molecules under laboratory conditions, which enhances understanding of the role of these molecules in living cells and for directed, artificial regulation of biological activity of the DNA by various chemical and biologically active compounds of medical importance. Catalog no. K13273, August 2011, c. 320 pp. ISBN: 978-1-4398-7146-1, $139.95 / £89.00

Nanobiomaterials Handbook Balaji Sitharaman Stony Brook University, New York, USA

Providing a comprehensive, definitive introduction to the field, this handbook discusses the scope, current status, and future prospects of nanobiomaterials. An in-depth overview of a wide-ranging subject, the book addresses the various synthesis and processing techniques important for developing nanobiomaterials. It also includes a detailed analysis of the interaction between bionanomaterials/biological systems, as well as associated biocompatibility issues. Extensive references are included at the end of each chapter to enhance additional study. Catalog no. 94661, June 2011, c. 840 pp. ISBN: 978-1-4200-9466-4, $169.95 / £108.00

Coming Soon!

New!

Colloids and Interfaces in Life Sciences and Bionanotechnology Second Edition

Medical Nanotechnology and Nanomedicine

Willem Norde

Harry F. Tibbals

Wageningen University, The Netherlands

University of Texas Southwestern Medical Center, Dallas, USA

This book is a concise introductory treatment of the physicochemical principles that determine interrelated colloidal and interfacial phenomena and their relevance to various life sciences. It focuses on concepts that form the basis for understanding this behavior. Whether deciphering the spontaneous assembly of amphiphilic molecules or the intentional fouling of surfaces for the immobilization of cells in bioreactors, this text devotes special attention to reversible and soft colloids. It also discusses the colloidal domain in a historical perspective, the size and distribution of particles, electrokinetic phenomena, and other topics.

Making information easy to access and digest, this book reviews advances in nanoscience and nanotechnology and considers their applications in medicine. An introduction to both the science and the infrastructure required to support these advances, this volume is written for non-experts, including medical researchers and clinicians, as well as those concerned with business aspects, regulation, and the administration of medical practices. The book provides a contextual background that includes history, definitions, and recent trends. It investigates current and future nanotech applications in medicine and the biomedical sciences.

Catalog no. K10890, June 2011, c. 512 pp. ISBN: 978-1-4398-1718-6, $129.95 / £39.99

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Catalog no. K10431, January 2011, 527 pp. Soft Cover, ISBN: 978-1-4398-0874-0 $69.95 / £44.99

New and Noteworthy Books in Biotechnology from CRC Press


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Nanobiotechnology Coming Soon!

Micro and Nano Techniques for the Handling of Biological Samples Edited by

Jaime Castillo, Winnie Edith Svendsen, and Maria Dimaki Technical University of Denmark, Lyngby

The techniques and tools used to understand many biological problems must enable researchers to handle biological material without damaging or altering its natural state. This timely book explores various micro and nano techniques currently available to effectively manipulate biological samples, highlighting the advantages and limitations of each method. This book helps readers understand how the manipulation tools work and how to determine the appropriate tool for their needs.

Features • Improves on existing books, which describe techniques separately or focus on in vivo and in vitro applications, leaving out several important techniques • Describes controlled material manipulation techniques, including sliding, repositioning, and relocation using external forces • Illustrates alternative techniques and how they can be used in research and analytical laboratories

Contents Interfacing Biological Material with Micro- and Nano Devices. Atomic Force Microscopy for Liquid applications. Manipulation by Electrical Fields. Optical Manipulation Techniques. Ultrasonic Manipulation Techniques. 3D Biomanipulation Using Microgrippers. Magnetic Manipulation of Biological Structures. Microfluidic Manipulation of Biological Samples. Catalog no. K11354, August 2011, c. 280 pp. ISBN: 978-1-4398-2743-7, $129.95 / £82.00

Digital Microfluidic Biochips Design Automation and Optimization Krishnendu Chakrabarty Duke University, Durham, North Carolina, USA

Tao Xu Cisco Systems, Cary, North Carolina, USA

Promoting functional diversification within biotech, pharmaceuticals, and other industries. Microfluidic Biochips: Design Automation and Optimization elaborates on the appropriate design tools and in-system automation methods that will help users adapt to new technology and progress in chip design and manufacturing. Using real-life bioassays as examples to lay out an automated design flow for creating microfluidic biochips, the authors develop solutions to the unique problems associated with that process.

Revolutionary guidance on design, optimization, and testing of low-cost, disposable biochips In addition to covering automated design, the authors provide a detailed methodology for the testing, use, and optimization of robust, costefficient, manufacturable digital microfluidic systems used in protein crystallization and other areas. The invaluable tools and practices presented here help readers to: • Simultaneously make routing-aware, architectural-level design choices and defect-tolerant physical design decisions • Achieve the goal of optimization, which includes minimizing time to response, chip area, and test complexity • Effectively deal with practical issues such as defects, fabrication cost, physical constraints, and application-driven design With a focus on cost and disposability, the authors present specialized pin-constrained design techniques for making biochips. They also discuss chip testing to ensure dependability, which is key to optimizing safety-critical applications including point-of-care medical diagnostics, on-chip DNA analysis, automated drug discovery, air-quality monitoring, and food-safety testing. Catalog no. K11010, 2010, 213 pp. ISBN: 978-1-4398-1915-9, $139.95 / £89.00

For more information and complete contents, visit www.crcpress.com

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Biotechnology Sensors for Chemical and Biological Applications Edited by

Manoj Kumar Ram Venkat R. Bhethanabotla University of South Florida, Tampa, USA

Offering versatile hands-on tools for professionals in a broad array of disciplines, Sensors for Chemical and Biological Applications delves into the potential of chemical and biochemical sensors in medical science, food quality, biological, and environmental applications. Examining the role of nanotechnology in their development, this book explores how sensors are used in the fight against chemical-bioterrorism, with their enhanced specificity, fast response times, and application for determining multiple hazardous substances. The book also details practical examples of other uses, including for cholesterol monitoring. The theme of nanotech is maintained throughout the book, with chapters that cover: • Sensing principles for chemical, electrical, chromatographic, magnetic, biological, fluidic, optical, and ultrasonic and mass sensing systems • Issues associated with cost, synthesis, and testing of new low cost materials with high sensitivity, selectivity, robustness, and speed for defined sensor applications

Coming Soon!

Support Vector Machines and Their Application in Chemistry and Biotechnology Yizeng Liang, QingSong Xu. Hong-Dong Li, and Dong-Sheng Cao Central South University, Changsha, China

Bridging theory and application, this volume describes support vector machines (SVMs) from the point of view of chemists and biologists. It discusses elements and algorithms associated with support vector classification (SVC) machines and support vector regression machines (SVRs), the kernel function for solving nonlinear problems, ensemble learning of SVM, and its applications to near-infrared data. It also addresses quantitative structure-activity/property relationship (QSAR/QSPR), quality control of traditional Chinese medicine using the chromatography fingerprint technique, and use of SVM to evaluate biological data in the OMICS study. Catalog no. K11127, April 2011, c. 201 pp. ISBN: 978-1-4398-2127-5, $119.95 / £76.99

• Analysis of the future impact of chemical and biological sensors in day-to-day life

Environmental Microbiology for Engineers

Features

Volodymyr Ivanov

• Provides a comprehensive overview of chemical and biochemical sensors • Covers applications of the solid-state gas sensor in the control and monitoring of chemical processes and living environments • Discusses the increasing importance of micro electromechanical systems (MEMS) and acoustic wave (SAW) in sensor applications • Explores the importance of biosensor in the measurement of food quality and environmental quality • Includes coverage of advanced techniques for detection of bio-chemical warfare agents Catalog no. 3366, 2010, 390 pp. ISBN: 978-0-8493-3366-8, $129.95 / £82.00

Nanyang Technological University, Singapore

Designed for engineers with little or no biology training, this book covers diverse functions of microorganisms in environmental engineering systems, environmental bioengineering processes, and applied microbial genetics and molecular biology. It also addresses their use in water and wastewater treatment, biotreatment and bioremediation, and microbial monitoring. Other topics include biocorrosion in construction, biodeterioration of materials, biocementation and bioclogging of soil, biopollution of indoor environments, and biofouling of facilities. Each chapter includes quizzes and tutorials, and a solutions manual is available with qualifying course adoption. Catalog no. 92340, January 2011, 438 pp. ISBN: 978-1-4200-9234-9, $99.95 / £63.99

10 New and Noteworthy Books in Biotechnology from CRC Press


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Biotechnology Coming Soon! New!

Colloids in Biotechnology Edited by

Monzer Fanun Al-Quds University, East Jerusalem, Palestine

Representing some of the earliest uses of nano, colloids continue to demonstrate great potential in a wide variety of applications, including drug delivery and medical imaging. This work describes developments in the area of biotechnological applications in the past decade and shows the connection between research efforts and commercially viable options. Striking a balance between the theoretical and experimental, between principles and applications, and between molecular and physical approaches to the subject, this book: • Assembles contributions from an international community of colloid / nano scientists • Discusses new types of biosurfactants, mixtures of surfactants, and peptides, proteins, and polyelectrolytes • Describes the formation and properties of magnetic colloids and their applications in chemical biology and medicine • Highlights progress in the design of self-assembled materials for biotechnology

Contents (abridged):

Gene Biotechnology Third Edition William Wu, Helen H. Zhang, Michael J. Welsh, and Peter B. Kaufman What Reviewers said About Previous Editions: “I can recommend this book to any molecular biologist without hesitation and would not be surprised if soon it establishes itself as one of the definitive guides to laboratory practice.” —Annals of Botany

The third edition of this popular reference covers a variety of techniques related to gene manipulation, including DNA isolation, preparation, screening, and analysis. Topics range from very basic methods to current and sophisticated technologies, including methodologies created and tested by the authors. Other topics include approaches to grant funding and SiRNA technology. The authors offer detailed, step-by-step explanations of protocols and helpful troubleshooting guides. This edition features new techniques for every chapter, as well as several new chapters.

Features • Covers state-of-the-art technologies, including the latest information on gene manipulation • Includes practical applications with coverage of current techniques and methods • Contains detailed, step-by-step explanations of protocols • Offers troubleshooting guides

Amphiphilic Biopolymers: DNA and Cellulose Mode of Interaction of Artificial Pulmonary Surfactant with an Amphiphilic-Helical Peptide at the Air/Water Interface Supramolecular Assemblies Formed by SelfAssembling Peptides Physicochemical Characterization of Anisotropic Molecules (Polyelectrolytes and Proteins) in Bulk Solutions Lysine-Based Surfactants Synthesis of Proteins in Cell-Free Systems Nonfood Applications of Milk Proteins: A Review The Role of Colloidal Delivery Systems in DNA Genetic Therapeutics Affinity Magnetic Beads for Chemical Biology and Medicine

Strategies for Novel Research Projects and Research Grant Funding. Rapid Isolation of Specific cDNA or Gene by PCR. Construction and Screening of Subtracted and Complete Expression cDNA Libraries. Subcloning of Genes or DNA Fragments. Non-isotopic and Isotopic DNA or RNA Sequencing. Information Superhighway and Computer Databases of Nucleic Acids & Proteins. Characterization of DNA or Genes by Southern Blot Hybridization.

Catalog no. K11511, January 2011, 547 pp. ISBN: 978-1-4398-3080-2, $159.95 / £99.00

Catalog no. K12153, May 2011, c. 584 pp. ISBN: 978-1-4398-4830-2, $149.95 / £95.00

Contents (abridged):

For more information and complete contents, visit www.crcpress.com

11


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Biotechnology Systems Biology and Bioinformatics

Coming Soon!

A Computational Approach

Ane Books, India

Kayvan Najarian, Siamak Najarian, Shahriar Gharibzadeh, and Christopher N. Eichelberger Written by accomplished field experts, this authoritative text provides a comprehensive collection of the computational methods used in what is being coined the digital era of biology. It first introduces systems biology and its impact on biology and medicine. It then reviews the basic principles of molecular and cell biology using a system-oriented approach, with a brief description of the high-throughput biological experiments that produce databases. The text includes techniques to discover genes, perform nucleotide and amino acid sequence matching, and estimate static gene dynamic pathways. It also explains how to use system-oriented models to predict the behavior of biological systems for important applications such as rational drug design. The numerous examples and problem sets allow readers to confidently explore practical systems biology applications using real examples with real biological data.

Features • Provides methods to integrate high level imaging data and molecular level measurements to model biological systems • Presents needed biological and mathematical basics • Includes practical examples and experiments with real data • Covers a variety of computational approaches and advanced mathematical methods

Contents (abridged) Cell Biology. Bioassays. Review of Some Computational Methods. Computational Structural Biology: Protein Structure Prediction. Computational Structural Biology: Protein Sequence Analysis. Genomics and Proteomics. Methods for Identification of Differentially Expressed Genes or Proteins. Binary and Bayesian Networks as Static Models of Regulatory Pathways.

Bioseparation Technology Neeraj Mishra and Akhilesh Dubey Designed for those with a background in engineering or biology, this text explores the fundamentals of the emerging field of bioseparation technology. It begins with an introduction to bioprocesses and provides focused chapters on cell disruption, filtration, centrifugation, adsorption, and extraction. The book also examines membrane separation processes, precipitation, chromatography, electrokinetic and other methods of separation, as well as finishing operations and formulation. Catalog no. N10039, August 2011, c. 300 pp. Soft Cover, ISBN: 978-1-4398-0172-7 $49.95 / £31.99

Illustrated Dictionary of Biotechnology Himanshu Arora Ane Books, India

Helping to support a common language in this rapidly evolving field, this illustrative reference explores a range of terms wide enough to satisfy the needs of researchers, clinicians, lawyers, investors, students, and instructors, or anyone else whose work involves new advances in science and medicine. This lucid resource provides straightforward definitions and invaluable background information so that even complex terms require only a rudimentary understanding of the life sciences. Extensive cross-referencing expands individual definitions, enabling readers to follow a chosen theme. Illustrations are included where they enhance understanding. Catalog no. N10040, 2009, 450 pp., Soft Cover ISBN: 978-1-4398-0173-4, $61.95 / £39.99

Catalog no. 46500, 2009, 190 pp. ISBN: 978-1-4200-4650-2, $71.95 / £45.99

12 New and Noteworthy Books in Biotechnology from CRC Press


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Biotechnology

Essentials of Biotechnology R.C. Sobti and Suparna S. Pachouri Punjab University, India

This comprehensive volume starts with an overview of early applications that scientists employed long before the biotech field was defined. It then moves on to examine the emergence of methods and specialized tools in the field, as well as cell culture and nucleic acidbased technologies. It devotes individual chapters to the application of biotechnology in the areas of health, agriculture, environment, aquaculture, and food. Next, the authors cover biotechnology in developing countries, with special reference to India. They also discuss debated ethical considerations and explore ongoing issues regarding intellectual property rights and patents. Catalog no. AB8284, 2009, 750 pp. ISBN: 978-1-4200-8284-5, $129.95 / £83.00

Molecular Biotechnology Principles and Practices Channarayappa Vydehi Institute for Biotechnical Sciences, Genetics Department, Bangalore, India

Providing a strong informational base in this promising field, this book strikes a balance between two important aspects of the science: the theory of molecular biology and the experimental approach to the study of biological processes. The main feature of this student- and teacher-friendly textbook is that it covers a wide range of molecular techniques in biotechnology. It describes individual techniques conceptually, followed by a detailed experimental account of the steps involved. The book can also serve as reference for newcomers to the field of biotechnology. Catalog no. UN5157, 2007, 1228 pp. ISBN: 978-1-4200-5157-5, $119.95 / £76.99

Emerging Protein Biotherapeutics Edited by

Iqbal S. Grewal Pre-clinical Therapeutics, Seattle Genetics, Inc., Bothell, Washington, USA

As antibody therapy becomes increasingly accepted, a comprehensive industry guide is sorely needed. Written by leading international authorities, this book emphasizes various therapeutic approaches and applications, providing critical discussions on the most significant areas of research in biologics. It focuses on the applications of protein biologics in autoimmunity and inflammation, hematological malignancies, and solid tumors. Each chapter clearly presents the most informative and contemporary available account of its subject, making this an unrivaled reference source that will help those in both academia and biotechnology industries.

Features • Provides a comprehensive overview of protein biologics and their development for clinical applications • Covers the major areas currently targeted in solid tumors, hematological malignancies and autoimmune diseases • Offers contributions from leading international authorities • Includes a vivid color insert with detailed illustrations to bolster understanding

Contents (abridged) INTRODUCTION. Overview of Antibody-Based Therapeutics: Present and Future Promise. BIOLOGICS FOR AUTOIMMUNITY AND INFLAMMATION. Biologic Therapies for Multiple Sclerosis. Biologic Therapies in Rheumatoid Arthritis. Biologic Therapies in Systemic Lupus Erythematosus. Biologic Therapies for Inflammatory Bowel Disease. Biologic Therapies for Psoriasis. TNFa Inhibitors: Emerging Biologic Therapies for the Treatment of Asthma. ProteinBased Therapies in Experimental and Clinical Transplantation. Biologic Therapies for Type 1 Diabetes. BIOLOGICS FOR HEMATOLOGICAL MALIGNANCIES. Biologic Therapies for Acute Myeloid Leukemia/Myelodysplastic Syndrome. Catalog no. 63200, 2009, 368 pp. ISBN: 978-1-4200-6320-2, $164.95 / £105.00

For more information and complete contents, visit www.crcpress.com

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Medicine & Biology New!

Biomedical Microsystems

The Delivery of Regenerative Medicines and Their Impact on Healthcare

Ellis Meng

Edited by

New!

University of Southern California, Los Angeles, USA

Poised to dramatically impact human health, biomedical microsystems (bioMEMS) technologies incorporate various aspects from materials science, biology, chemistry, physics, medicine, and engineering. Reflecting the highly interdisciplinary nature of this area, Biomedical Microsystems covers the fundamentals of miniaturization, biomaterials, microfabrication, and nanotechnology, along with relevant applications. Written by an active researcher who was recently named one of Technology Review’s Young Innovators Under 35, the book: • Details the benefits of miniaturization, introducing materials, fabrication technology, and the necessary components of all bioMEMS • Covers fundamental principles and building blocks, including microfluidic concepts, lab-on-a-chip systems, and sensing and detection methods • Explores several important applications of bioMEMS, such as microdialysis, catheterbased sensors, MEMS implants, neural probes, and tissue engineering For readers with a limited background in MEMS and bioMEMS, this book provides a practical introduction to the technology used to make these devices, the principles that govern their operation, and examples of their application. It offers a starting point for understanding advanced topics and encourages readers to begin to formulate their own ideas about the design of novel bioMEMS. A solutions manual is available for instructors who want to convert this reference to classroom use. Catalog no. 51229, January 2011, 408 pp. ISBN: 978-1-4200-5122-3, $89.95 / £49.99 .

Catherine Prescott Biolatris Ltd., Cambridge, UK

Dame Julia Polak Imperial College, London, UK

Based on input from an international panel of experts, this book provides first-hand experience of the challenges and opportunities facing the delivery of regenerative medicines to patients. It highlights key issues beyond science and clinical translation, such as finance and business models, intellectual property, and regulatory landscapes, as well as questions of how regenerative medicines will be evaluated for reimbursement. It also covers legal issues relevant to regulators, insurers, and investors, as well as pharmaceutical and biotech researchers. Catalog no. K11628, January 2011, 400 pp. ISBN: 978-1-4398-3606-4, $169.95 / £108.00

New!

Introduction to Complexity and Complex Systems Robert B. Northrop University of Connecticut, Storrs, USA

Written for students and professionals in the fields of biomedical engineering, systems biology, biophysics, and physiology, this unique reference covers complexity issues within living systems. Topics include human responses to coping with complex systems, the Law of Unintended Consequences, the relation of complexity to evolution, the complexity inherent in invertebrate immune systems, and the complexity inherent in economic systems. A comprehensive glossary provides acronyms and terms relating to complex, nonlinear biological systems. Also included are dynamic models and homework questions to further aid in understanding. Catalog no. K11775, January 2011, 551 pp. ISBN: 978-1-4398-3901-0, $79.95 / £44.99

14 New and Noteworthy Books in Biotechnology from CRC Press


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Medicine & Biology

Coming Soon! New!

Biology for Engineers Arthur T. Johnson

Mechanobiology Handbook Edited by

Jiro Nagatomi

University of Maryland, College Park, USA

Clemson University, South Carolina, USA

Biology is a critical application area for engineering analysis and design, and students in engineering programs must be well-versed in the fundamentals of biology as they relate to their field. Biology for Engineers is an introductory text that minimizes unnecessary memorization of connections and classifications, instead emphasizing concepts, technology, and the utilization of living things.

Familiarizing readers with the basic concepts of mechanics and the modern tools of cellular/molecular biology, this book covers the mechanical stimuli necessary for growth and maintenance of healthy tissues and organs. Mechanobiology examines effects of mechanical force stimuli on cellular biological functions, and research has increased dramatically in the past two decades. A presentation of cutting-edge research findings from a diverse range of scientists, this volume addresses basic materials in mechanics and cell biology. It was designed to stimulate new ways of thinking in current mechanobiology researchers create new therapies and further biological understanding.

Classroom-tested at the University of Maryland, this comprehensive text introduces concepts and terminology needed to understand more advanced biology literature. Filled with practical detailed examples, the book presents: • Scientific principles relevant to biology that all engineers must know • A discussion of biological responses from the perspective of fields such as psychology, human factors, genetics, plant and animal physiology, imaging, control systems, actuary, and medicine • A thorough examination of the scaling of biological responses and attributes • A classification of different types of applications related to biological systems • Tables of useful information that are nearly impossible to find elsewhere Emphasizing the ever-present interactions between a biological unit and its physical, chemical, and biological environments, the book provides ample instruction on the basics of physics, chemistry, mathematics, and engineering. It brings together all of the concepts one needs to understand the role of biology in modern technology. Catalog no. 77635, January 2011, 775 pp. ISBN: 978-1-4200-7763-6, $99.95 / £44.99

Features • Presents research data and viewpoints from diverse fields of mechanobiology • Quantifies the mechanical environment of cells and the molecular mechanisms of mechanically induced pathological conditions • Includes background information in mechanics and cell biology • Explores application areas such as tissue engineering • Contains references at the end of each chapter to facilitate further study

Contents Basic Science Tools for Mechanobiology Research. Primer of Biomechanics. Primer of Molecular Cell Biology. Literature Review of Mechanobiology Research Findings and Theories. Mechanobiology in Musculoskeletal Systems. Mechanobiology in Cardiovascular Systems. Mechabobiology in other Organ Systems. Applications of Mechanobiology. Catalog no. 91212, March 2011, 563 pp. ISBN: 978-1-4200-9121-2, $169.95 / £109.00

For more information and complete contents, visit www.crcpress.com

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Drug Discovery & Delivery Fundamentals of Microfluidics and Lab on a Chip for Biological Analysis and Discovery

New!

Paul C.H. Li

Donald C. Lo

Simon Fraser University, Burnaby, British Columbia, Canada

Duke University Medical Center, Durham, North Carolina, USA

Authored by one of the field’s pioneering researchers, this volume focuses on all key aspects of the microfluidic lab-on-a-chip technologies. It offers an exceptionally cohesive overview of the science, including its limitations and breakthroughs. The book emphasizes analytical applications of microfluidic technology and covers micromachining methods, microfluidic operations, chemical separations, sample preparation and injection methods, detection technology, and various chemical and biological analyses.

Robert E. Hughes

Features • Reviews fundamentals of micromachining and fluid flow and control for lab-on-a-chip • Emphasizes analytical applications of microfluidic technology • Includes information that is key to cell, nucleic acid, protein, and genetic analyses, including DNA sequencing • Adapts traditional principles of operations for the size of a chip, optimizing the miniaturization advantage and favorable scaling down • Contains tables that summarize related materials and problem sets that test comprehension of the material • Includes a glossary and extensive references along with a four-page color insert Solutions manual is available with qualifying course adoption

Contents Micromachining Methods. Microfluidic Flow. Sample Introduction. Sample Preconcentration. Separation. Detection Methods. Applications to Cellular/Particle Analysis. Applications to Nucleic Acids Analysis. Applications to Protein Analysis. References. Glossary. Technology.

Neurobiology of Huntington’s Disease Applications to Drug Discovery Edited by

Buck Institute for Age Research, Novato, California, USA

Neurobiology of Huntington’s Disease: Applications to Drug Discovery presents a thorough review of the issues surrounding drug discovery and development for the treatment of this paradigmatic neurodegenerative disease. Drawing on the expertise of key researchers in the field, the book discusses the basic neurobiology of Huntington’s disease and how its monogenic nature confers enormous practical advantages for translational research, including the creation of robust experimental tools, models, and assays to facilitate discovery and validation of molecular targets and drug candidates for HD. Written to support future basic research as well as drug development efforts, this volume: • Covers the latest research approaches in genetics, genomics, and proteomics, including high-throughput and high-content screening • Highlights advances in the discovery and development of new drug therapies for neurodegenerative disorders • Examines the practical realities of preclinical testing, clinical testing strategies, and, ultimately, clinical usage

Contents Clinical Overview of HD. Genetics of HD. Molecular Pathology of Hungtingtin Function. Genomic, Protemoics, and Metabonomics of HD. High-throughput Screening in HD. Highcontent Screening in HD. Animal Models for HD. Pharmaceutical Development for HD. HD Clinical Trials. Catalog no. 9000, January 2011, 338 pp. ISBN: 978-0-8493-9000-5, $149.95 / £95.00

Catalog no. K10977, 2010, 418 pp., Soft Cover ISBN: 978-1-4398-1855-8, $99.95 / £38.99

16 New and Noteworthy Books in Biotechnology from CRC Press


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Drug Discovery & Delivery 3D Cell-Based Biosensors in Drug Discovery Programs Microtissue Engineering for High Throughput Screening William S. Kisaalita University of Georgia, Athens, USA

Written by William Kisaalita, one of the foremost experts in this field, this book provides the latest information — from theory to practice — on challenges and opportunities for incorporating 3D cell-based biosensors or assays in drug discovery programs. Based on cutting-edge research conducted in the author’s lab, it supplies a historical perspective and defines the problems that 3D cultures can solve. It also discusses how genomics and combinatorial chemistry have changed the way drug are discovered and presents data from the literature to underscore the less-than-desirable pharmaceutical industry performance under the new paradigm.

Features • Provides a deep comparative analysis of 2D and 3D cultures • Uses data from peer-reviewed publications to conclusively justify use of 3D cell cultures in cell-based biosensors (assays) for high throughput screening • Includes difficult-to-find information such as patents, cell lines or types commonly used in drug discovery programs, and their origins • Addresses research needs mainly in areas of detection and scaffold engineering • Describes microenvironment factors for creating phenotypes that resemble their in vivo counterparts • Incorporates case studies in support of 3D cell-based biosensor adoption in drug discovery programs

New!

Handbook of Analysis of Oligonucleotides and Related Products Edited by

Jose V. Bonilla Girindus America, Cincinnati, Ohio, USA

G. Susan Srivatsa ElixinPharma, Encinitas, California

Oligonucleotides represent one of the most significant pharmaceutical breakthroughs in recent years, showing great promise as diagnostic and therapeutic agents for malignant tumors, cardiovascular disease, diabetes, viral infections, and many other degenerative disorders. This volume is an essential reference manual on the practical application of modern and emerging analytical techniques for the analysis of this unique class of compounds. Using the collaborative contributions from 30 leading analytical scientists from around the world, the book provides readers with a comprehensive overview of the most commonly used analytical techniques and their advantages and limitations in assuring the identity, purity, quality, and strength of an oligonucleotide intended for therapeutic use.

Features • Presents a unique compilation of the latest techniques for the analysis of oligonucleotides • Explores the current status of regulatory expectations for clinical development of this novel technology • Provides bioanalysis of oligonucleotides in support of therapeutic development • Describes practical applications that can be readily implemented in research, development, or QA/QC laboratories

Contents (abridged)

Introduction. Biosensors and Bioassays. TargetDriven Drug Discovery. 3D versus 2D Cultures. Comparative Genomics and Proteomics. Comparative Structure and Function. Emerging Design Principles. Chemical Microenvironmental Factors. Spatial and Temporal Microenvironmental Factors.

Purity Analysis and Impurities Determination by Reversed-Phase High- Performance Liquid Chromatography. Purity Analysis and Impurities Determination by AEX-HPLC. Purity Analysis and Molecular Weight Determination by Size Exclusion HPLC Analysis. Analysis of Oligonucleotides by Liquid Chromatography— Mass Spectrometry. Sequence Determination and Confirmation by MS/M S and MALDI-TOF. Tm Analysis of Oligonucleotides.

Catalog no. 73494, 2010, 404 pp. ISBN: 978-1-4200-7349-2, $129.95 / £82.00

Catalog no. K11050, February 2011, 511 pp. ISBN: 978-1-4398-1993-7, $139.95 / £89.00

Contents

For more information and complete contents, visit www.crcpress.com

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Drug Discovery & Delivery Antisense Drug Technology Principles, Strategies, and Applications, Second Edition Edited by

Stanley T. Crooke ISIS Pharmaceuticals Inc., Carlsbad, California, USA

“…provides valuable insights into the great opportunities that are presented by this technology.” —Dr. Kees Fluiter, The University of Amsterdam, in ChemMedChem

“…[includes] a variety of compelling clinical case studies, and … retains the superb basic principles and background to antisense drug technologies featured in the first edition.” —Gary Evans, Industrial Research Ltd., in Journal of Medicinal Chemistry

Incorporating lessons learned from first generation clinical trials, this book evaluates the technology as a whole and assesses the direction of research and development. It explains mechanisms of action, pharmacokinetics of delivery, and the therapeutic potential of antisense drugs, ologonucleotides, hybridization-based drugs, duplex RNA, and more. Leading researchers discuss improvements to second-generation drugs and consider the potential of antisense drugs for the alleviation of cardiovascular diseases, metabolic diseases, inflammatory diseases, cancer, neurological disorders, and immune modulation.

Features

Coming Soon!

Transdermal and Intradermal Delivery of Therapeutic Agents Application of Physical Technologies Ajay K Banga Mercer University, Atlanta, Georgia, USA

Interest in drug delivery systems is growing as the delivery of many drugs continues to be a problem due to safety, stability, and compliance issues. This is especially true for the increased number of biologic medicines, which include peptides, proteins, and nucleic acids. Transdermal delivery is an important part of such systems, and the field is headed toward the use of physical enhancement methods to penetrate the skin barrier. This book reviews the strategies available for the delivery of compounds this way. It also focuses on nanotech developments that can be exploited to enhance the transdermal delivery of drugs. Catalog no. K10285, May 2011, c. 330 pp. ISBN: 978-1-4398-0509-1, $129.95 / £82.00

Drug Device Combination Products Delivery Technologies and Applications

• Details the logarithmic progress of oligonucleotide-based therapeutics, particularly antisense therapeutics • Interprets pharmaceutical technology setbacks within the context successful advancements in the field • Examines chemistries and mechanisms including 2’ methoxyethyl chimeras and duplex RNA • Illustrates concepts with numerous tables, as well as black and white illustrations and color figures • Offers contributions from leaders in the field, including the CEO of ISIS Pharmaceuticals, a nationally recognized expert in the field of biotechnology

Drug delivery systems represent a vast area of research and development within biomaterials and medicine, and the demand for sophisticated drug delivery devices continues to drive novel product development. Illustrating how effective drug delivery can be achieved through means other than the use of oral tablets, this book provides a thorough analysis of the fundamentals, applications, and new technologies of drug-device combination products for use throughout the human body. Topics featured include background information, areas of application and the development of drug device combination products.

Catalog no. 8796, 2008, 848 pp. ISBN: 978-0-8493-8796-8, $257.95 / £164.00

Catalog no. N10136, 2010 ISBN: 978-1-4398-2479-5, $244.99 / £155.00

Edited by

A. Lewis Biocompatibles UK Ltd.

18 New and Noteworthy Books in Biotechnology from CRC Press


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Clinical Trials New!

Coming Soon!

Handbook of Adaptive Designs in Pharmaceutical and Clinical Development

Controversial Statistical Issues in Clinical Trials

Edited by

Annpey Pong Merck Research Laboratories, Rahway, New Jersey, USA

Shein-Chung Chow Duke University School of Medicine, Durham, North Carolina, USA

This handbook provides a comprehensive and unified presentation of the principles and latest statistical methodologies used when modifying trial procedures based on accrued data of ongoing clinical trials. The book also gives a well-balanced summary of current regulatory perspectives and presents real-world examples of a range of adaptive designs. Leading clinical researchers in the pharmaceutical industry, academia, and regulatory agencies examine issues commonly encountered when applying adaptive design methods in clinical trials. They discuss the importance of sample size estimation/allocation, justification, and adjustment when implementing a complicated adaptive design.

Features • Explores the use of adaptive design methods in clinical trials • Describes the latest developments and best practices • Examines the role of an independent data safety monitoring board

Contents

Shein-Chung Chow Duke University School of Medicine, Durham, North Carolina, USA

Covering several controversial issues commonly encountered during clinical trials, this book serves as a useful desk reference and assessment of the state of the art. It discusses the appropriateness of traditional statistical hypotheses, which focus primarily on efficacy and safety in clinical evaluation, instability of classical sample size calculation based on information from a small pilot study, and integrity of randomization and blinding. The author illustrates the issues using real-world examples and the latest data. He also recommends possible resolutions of these issues.

Features • Identifies controversial issues commonly encountered in clinical research and development • Studies critical issues that impact clinical investigation of a test treatment • Provides resolutions and recommendations for action regarding controversial issues discussed • Outlines recent development and/or future perspective • Includes chapter-end examples and remarks

Contents

Overview of Adaptive Design Methods in Clinical Trials. Fundamental Theory of Adaptive Designs with Unplanned Design Change in Clinical Trials with Blinded Data. Bayesian Approach for Adaptive Design. The Impact of Protocol Amendments in Adaptive Trial Designs. From Group Sequential to Adaptive Designs. Determining Sample Size for Classical Designs. Sample Size Reestimation Design with Applications in Clinical Trials. Adaptive Interim Analyses in Clinical Trials. Classical Dose-Finding Trial. Improving Dose-Finding: A Philosophic View. Adaptive Dose-Ranging Studies. Seamless Phase I/II Designs. Phase II/III Seamless Designs.

Good Statistical Practices. Bench-to-Bedside Translational Research. Bioavailability and Bioequivalence. Hypotheses for Clinical Evaluation and Significant Digits. Instability of Sample Size Calculation. Integrity of Randomization/Blinding. Clinical Strategy for End Point Selection. Protocol Amendments. Seamless Adaptive Trial Designs. Multiplicity in Clinical Trials. Independence of DataMonitoring Committee. Two-Way ANOVA versus One-Way ANOVA with Repeated Measures. Validation of QOL Instruments. Missing Data Imputation. Center Grouping. Non-Inferiority Margin. QT Studies with Recording Replicates. Multiregional Clinical Trials.

Catalog no. K10507, January 2011, 496 pp. ISBN: 978-1-4398-1016-3, $99.95 / £63.99

Catalog no. K12247, June 2011, c. 612 pp. ISBN: 978-1-4398-4961-3, $99.95 / £63.99

For more information and complete contents, visit www.crcpress.com

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Industry Applications

Includes CD-ROM

Biotechnology A Comprehensive Training Guide for the Biotechnology Industry Syed Imtiaz Haider and Anika Ashtok Julphar Gulf Pharm Industries, United Arab Emirates

All manufacturing companies face the daunting task of designing an employee training matrix that meets the gamut of national and international regulatory standards. Answering the call for a one-stop training resource that focuses exclusively on this multi-faceted, high-tech industry, Biotechnology: A Comprehensive Training Guide for the Biotechnology Industry provides ready-to-implement training templates that save time and expense without cutting corners on critical elements.

Attached CD-ROM: Why Reinvent the Wheel? This complete, single-source reference contains 28 complete biotechnology courses and a customizable CD-ROM with hands-on training tools. The book also provides time-saving information on how to orient employees involved in writing and executing batch manufacturing and in-process control documents.

Key Benefits • Contains adaptable training text, test summaries and papers, test answers, and certificates of completion • Streamlines the training process, maximizing efficiency • Boosts the marketing edge over competitors This valuable training tool presents step-by-step guidance for optimizing research and development expenditures, avoiding marketing delays, gaining a competitive advantage, reducing product development failures, developing skilled manpower, and maintaining local and international regulatory compliance.

Contents Microbial Growth Text. Culturing Microorganisms. Bioreactor Configurations Text. Bioreactor Design Features Text. Lyophilization: Growing with Biotechnology Text. Shear Effects in Culture Text. Energy Input in Bioreactors Text. Downstream Processing Text. Mammalian Cell Cultures Text. Plant Cell Cultures Text. Fermentation Text. Characteristics of Cells in Culture Text. Cell Lysis Text. Cells Fractionation Text. Centrifugation Text. Homogenization Text. Refolding of Inclusion Bodies Text. Solubilization and Refolding of Proteins Text. Inclusion Bodies Solubilization Text. Sludge Treatment Text. Freeze Drying Text. Vacuum Drying Text. Diafilteration Text. Partition Chromatographs Text. Adsorption Chromatographs Text. Gel Filteration Chromatographs Text. Techniques of Genetic Engineering Text. Industrial Biosafety Text. Certificate of Attainment. Biotechnology Training Records. Recommended Readings. Appendices.

Catalog no. 84488, 2009, 868 pp., Soft Cover ISBN: 978-1-4200-8448-1, $102.95 / £65.99

20 New and Noteworthy Books in Biotechnology from CRC Press


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Industry Applications

Biotechnology Operations Principles and Practices Michael J. Roy University of Wisconsin-Madison, USA

Master Basic Principles and Practices to Reduce Risk Because of rapid developments in the biotechnology industry—and the wide range of disciplines that contribute to its collective growth—there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: • Biomanufacturing • Clinical trials • Nonclinical studies • Project management • Quality assurance • Quality control • Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference: • Illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional area

• Draws from the author’s experiences working in industry and teaching a graduate course at the University of Wisconsin • Clarifies basic methodologies and practices to help reduce risks and resolve problems as technological discoveries are forged into tangible products

Contents Introduction to Biotechnology Operations: Planning for Success Project Management Regulatory Affairs Regulatory Compliance Quality Systems Biomanufacture Quality Control Nonclinical Studies Clinical Trials Glossary Additional Reading Practical Problems and Questions

• Applies developmental principles and lessons learned to help bring future products to market more safely and efficiently Catalog no. K11486, March 2011, 416 pp. ISBN: 978-1-4398-3027-7, $99.95 / £63.99

For more information and complete contents, visit www.crcpress.com

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Industry Applications New!

Intelligent Energy Field Manufacturing Interdisciplinary Process Innovations

Reverse Engineering Technology of Reinvention Wego Wang

Edited by

Wenwu Zhang GE Global Research Center, Schenectady, New York, USA

An in-depth introduction to Intelligent Energy Field Manufacturing (EFM), this book explores a fresh engineering methodology that not only integrates but also goes beyond methodologies such as Design for Six Sigma, Lean Manufacturing, Concurrent Engineering, selfassembly, biometics, and more. It discusses dynamic M-PIE flows, the generalities of energy fields, logic functional materials and intelligence, the open scheme of intelligent EFM implementation, and the principles of intelligent EFM. The book takes a highly interdisciplinary approach that includes research frontiers such as micro/nano fabrication, high strain rate processes, and laser shock forming, to name just a few.

Features • Provides an in-depth introduction to intelligent EFM and the so-called "non-traditional" manufacturing • Establishes the New Standard of Engineering Optimization (New CEO) that considers short-term benefits as well as long-term interests of an organization

University of Massachusetts, Lowell, USA

“The topic of this book represents an important technological field that has heretofore been ignored by academics, despite being well accepted in industry. I am delighted by its publication.” —Professor Lavernia, Dean of Engineering at UC Davis

Written to advance the technology of reinvention and improve the competitiveness of commercial parts in the aftermarket, this volume discusses the proper measurement and analysis techniques required to reproduce or repair an Original Equipment Manufacturer (OEM) part using modern reverse engineering technologies and regulations that govern the practice. Offering numerous real-world examples, the book enables readers to determine if a duplicated or repaired part can meet the design functionality of the original. Going beyond industrial manufacturing, the book also evaluates the use of reverse engineering in academic research, law, and forensics.

Features

• Discusses high level integration of information /intelligence flow into manufacturing

• Aids readers in evaluating the feasibility of a reverse engineering proposal or project • Shows how to analyze the relevant properties and data for materials identification and manufacturing process verification • Explains statistical applications in data processing as they relate to reverse engineering • Cites legal precedent on intellectual property and proprietary data, and discusses their effects on reverse engineering practice

• Explores future directions of intelligent EFM

Contents

• Supplies high level methodological reviews of process innovations in important engineering directions • Includes interdisciplinary process innovations with a focus on the artful manipulation of energy flows

Contents Basics of Intelligent EFM. Introduction to the Interdisciplinary Engineering Methodologies. Energy Flow and Interdisciplinary Process Innovations. Information Flow and Intelligent Manufacturing.

Geometrical Form. Material Characteristics and Analysis. Part Durability and Life Limitation. Material Identification and Process Verification. Data Process and Analysis. Part Performance and System Compatibility. Acceptance and Legality.

Catalog no. 71017, January 2011, 728 pp. ISBN: 978-1-4200-7101-6, $149.95 / £95.00

Catalog no. K10314, January 2011, 357 pp. ISBN: 978-1-4398-0630-2, $139.95 / £89.00

22

New and Noteworthy Books in Biotechnology from CRC Press


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Industry Applications

Includes CD-ROM

Quality Control Training Manual Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories Syed Imtiaz Haider and Erfan Asif Syed Julphar Gulf Pharm Industries, United Arab Emirates

Written to help companies comply with GMP, GLP, and validation requirements imposed by the FDA and regulatory bodies worldwide, Quality Control Training Manual: Comprehensive Training Guide for API, Finished Pharmaceutical and Biotechnologies Laboratories presents cost-effective training courses that cover how to apply advances in the life sciences to produce commercially viable biotech products and services in terms of quality, safety, and efficacy. This book and its accompanying CDROM comprise detailed text, summaries, test papers, and answers to test papers, providing an administrative solution for management. This book:

The biotechnology/bioscience industries are regulated worldwide to be in compliance with cGMP and GLP principles, with particular focus on safety issues. Each company must create a definite training matrix of its employees. The training procedures in this book enable end users to understand the principles and elements of manufacturing techniques and provide documentation language ranging from the generic to the specific. The training courses on the CD supply valuable tools for developing training matrices to achieve FDA, Health Canada, EMEA, MHRA UK, WHO, and GLP compliance.

• Provides the FDA, Health Canada, WHO, and EMEA guidelines directly applicable to pharmaceutical laboratory-related issues

Contents

• Offers generic formats and styles that can be customized to any organization and help management build quality into routine operations to comply with regulatory requirements

Analytical Methods, Techniques and Quality Measures for General. Pharmaceutical Products.

• Contains ready-to-use training courses that supply a good source of training material for experienced and inexperienced practitioners in the biotechnology/biopharmaceutical industries

Analytical Methods and Techniques for Biological Products.

• Includes a CD with downloadable training courses that can be adopted and directly customized to a particular organization

Assessment of Training Procedures.

• Supplies ready-to-use test papers that allow end users to record all raw data up to the issuance of the attached certificate

Training Log.

Laboratory Training Manual.

Training Assessment (Quiz and Answers).

Methods Master Validation Plan. HPLC re-Qualification SOP. GC Re-Qualification SOP. GLP Functions Dos/Donts.

Catalog no. K12268, February 2011, 484 pp. ISBN: 978-1-4398-4994-1, $139.95 / £89.00

For more information and complete contents, visit www.crcpress.com

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Industry Applications Coming Soon!

Distillation Control, Optimization, and Tuning Fundamentals and Strategies Lanny Robbins Larco Technologies LLC

With a focus on the fundamentals and strategies of distillation columns, this book covers the process variables for continuous distillation columns, as well as four basic control strategies and the typical cases in which they are used. The author defines the inlet and outlet streams and process variables for a distillation column and then explains the overall concept of the separation and purification that is performed. Performance and product quality are described in terms of specification requirements, and tools and techniques for the optimization of quality performance are provided. Figures and graphs are included within the reference to illustrate concepts.

Features

Includes CD-ROM

Cleaning Validation Manual A Comprehensive Guide for the Pharmaceutical and Biotechnology Industries Syed Imtiaz Haider and Erfan Syed Asif Julphar Gulf Pharm Industries, United Arab Emirates

With over 20 easy-to-use template protocols for cleaning validation of extensively used equipments, this book provides technical solutions to assist in fulfilling the training needs of finished pharmaceutical manufacturers. Drawing on the authors’ more than two decades of experience, the text offers hands-on training based on current approaches and techniques. The manual is organized as a database to support those involved in the development, manufacturing, auditing, and validation of bio-pharmaceuticals on a pilot scale, that can lead to scaled-up production. It also provides exclusive training guidelines in a CD-ROM to enable the users to amend or adapt processes as necessary.

• Focuses on the fundamentals and process control strategies of distillation columns

Features

• Covers process variables for continuous distillation

• Supplies a basic education of cleaning validation

• Discusses concepts that have proved successful • Provides the four basic control strategies and examples of use • Includes tools and techniques to optimize performance

Contents Introduction and Overview. Distillation Control Variables. Separation Power. Distillate/Feed Material Balance Split. Distillation Control Strategies. Constraints. Optimizing Product Quality Performance. PID Feedback Control Loop. Closed Loop Tuning of Controllers. Open Loop Testing of Process Response. Catalog no. K12689, April 2011, 144 pp. ISBN: 978-1-4398-5748-9, $149.95 / £95.00

• Gives an advanced approach to validation professionals who are already in the field to implement and execute a thorough cleaning validation program • Includes 23 easy-to-use template protocols for cleaning validation of extensively and most commonly used equipments, with sampling points identified through pictures • Covers a wide range of active ingredients, including their level of solubility in water and potency/toxicity so as to provide an easy way for validation professionals to create a worst-case matrix for different equipment • Provides a complete tool to understand, learn, think, and implement a validation program

Contents CLV-1 How to Establish a Cleaning Validation Program. CLV-2 Introduction. CLV-3 Scope and Approach. CLV-4 Cleaning Validation Team Members and Responsibilities. Catalog no. K11299, 2010, 608 pp. ISBN: 978-1-4398-2660-7, $139.95 / £89.00

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New and Noteworthy Books in Biotechnology from CRC Press


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Industry Applications

New!

Healthcare Biotechnology A Practical Guide Dimitris Dogramatzis Dogramatzis Pharmacy, Athens, Greece

It takes strong managerial skills and a solid grounding in biopharmaceutical research and development procedures to foresee and plan for all of the possibilities and pitfalls involved in bringing a biotechnology innovation from inception to widespread therapeutic use. Unfortunately there has been a dearth of resources for this aspect of the field. Until now. Focusing on the management of healthcare-related biotech, from conception through the product’s regulatory approval and entire life cycle, Healthcare Biotechnology: A Practical Guide provides a practical, applicable resource to assist all healthcare-related biotech professionals in their day-to-day activities from the lab to the boardroom. Divided into six sections, the book begins with current systems and recent progress and controversy, major players and products, and a comparison with the pharmaceutical industry. It covers intellectual property protection and management, the innovation cycle, patent application, commercialization, and competition. Coverage includes funding, partnering, cash-intensive activities, financing alternatives, and the complexities of alliance implementation and management. It highlights research, development, and biomanufacturing; and examines clinical trial design and regulations; "fast-track" approvals; and patient recruitment as well as production platforms and processes, costs, strategies, and timelines. It investigates marketing including planning, promotion, pricing, supply chain management, and biobrand lifecycle management. It concludes with tips on running the business, offering diverse biobusiness models and reasonable expectations from inception through maturity and decline. An indispensible guide, this book offers more than 40 figures, 220 tables, and 180 references as well as a list of abbreviations and a business plan outline. Each chapter contains ten questions to reinforce the material covered and ten exercises to challenge the reader and inspire critical thinking. Ancillary materials including solutions manual and over 1000 PowerPoint slides available for qualifying course adoption.

Features • Provides end-of-chapter problems and appropriate essays for each subject covered • Offers a practical step-by-step guide for both graduate students and industry professionals • Offers many illustrations, including over 260 tables and figures • Contains extensive references at the end of each chapter as well as three appendices to enhance further study

Contents THE HEALTHCARE BIOTECHNOLOGY INDUSTRY: Bioeconomy. INTELLECTUAL PROPERTY: Intellectual Property Management. Biolicensing. FUNDING: Biofinance. Biopartnering. NEW PRODUCT DEVELOPMENT: Biodrug Research. Biomanufacturing. MARKETING: Biomarketing planning. Biopromotion. Biopricing. Biosupply Chain. Product Life Cycle Management. RUNNING THE BUSINESS: Biobusiness models. Biosimilars Model. Biocompany Life Cycle. Catalog no. K12108, January 2011, 689 pp. ISBN: 978-1-4398-4746-6, $99.95 / £63.99

For more information and complete contents, visit www.crcpress.com

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MBCBT31_5.5x8.5_MC_J:MBCBT31 5.5x8.5 MC_J 3/21/11 5:21 PM Page 27

A Simplified Guide to One of the

Hottest Topics in Nano

Catalog no. K11126 April 2011 976 pp., ISBN: 978-1-4398-2125-1 $249.95 / ÂŁ159.00

Explores the state of the art in the development and implementation of advanced biological thin films and coatings‌ See page 3


6000 Broken Sound Parkway, NW, Suite 300 Boca Raton, FL 33487, USA

Page 21 Page 3

For a complete list of Biotechnology books please visit www.crcpress.com

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Biotechnology - April 2011  

New & Noteworthy Books in Biotechnology from CRC Press - April 2011

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