Product Description
Failure to follow one's own procedures is the single most-cited violation of the Good Manufacturing Practices (GMP) regulations. In this workshop in a book, Dr. Paul Sanghera, the best selling author of several books in science and technology, presents cohesive, concise, yet comprehensive introduction to the fundamentals of Standard Operating Procedures (SOPs) in context of Good Manufacturing Practices (GMP), quality assurance, and quality control. Those who can benefit from this book include students and professionals in biotechnology, health science, and other industries: especially those who are trying to meet the FDA regulations on SOPs. This is a general book for the beginners to develop a basic understanding about SOPs. Also the busy executives and managers will find this book useful for a quick introduction to SOPs. The material is presented in the format of lecture notes, which are self-contained, comprehensive within the scope of the book, and presented in an easy-to-follow logical learning sequence. All concepts are explained from scratch with enough examples and exercises. Example SOP templates are provided to put the concepts in practical context.Topics Include:*Introduction to SOPs*Effective SOPs*Producing Effective SOPs*Living with Approved SOPs: following, monitoring, and controlling SOPs*Process Based Approach to SOPs*Solutions to Self Test Exercises* Example SOP Templates*Glossary of terms ... Read more

Customer Reviews (1)

One of a Very Few Fine Books on SOPs
The need for writing and implementing effective SOPs in a whole spectrum of fields is on an exponential rise. Unfortuntely, there aren't many SOP books available in the market. This book by Dr. Paul Sanghera is one of a very few fine books on SOPs. If you are a beginner in the field of SOPs, this book is your book. It explains the basic SOP concepts from scratch and offers simple examples, exercises, and templates. It's a general book on SOPs that can be used by any reader in any field. It's a good starting point for any professional in any field who wants to start with writing and implementing effective SOPs. Topics covered include: Introduction to SOPs *Effective SOPs *Producing Effective SOPs *Living with Approved SOPs: following, monitoring, and controlling SOPs *Process Based Approach to SOPs *Solutions to Self Test Exercises * Example SOP Templates *Glossary of terms. I specifically like the process based approach to SOPs: very innovative and useful approach. The price is right.

Handbook of SOPs for Good Clinical Practice, Second Edition
This book bt Celin Clive provides quite a few ready to go SOP templates in the clinical field. The templates seem to be consistent with the International standards. The List of SOPs covered include Spnosor/monitor/CRO SOPs, Investigational site SOPs, and Institutional Rebiew Board SOPs. The book also includes some useful forms in the clinical industy. One thing that may concern the reader is that the book is priced very high.
Again, the book is focussed on the clinical industry. If you want a book to learn the basics of writing and implementing effective SOPs that could be applied to any field, begin with Dr. Sanghera's book reviewed above.
There is also another good book on SOPs reviewed below:

SOP Guidelines
This book by D.H. Shah covers SOPs in quite a few areas including Production, Quality Control, Quality Assurance, Stores, Engineering, Maintenance and Housekeeping. It also contains SOP templates in these fields. A good collection of SOPs on Tablets & Capsules, Ointments, Quality Control, Liquid Orals, and Sterile Preparations. The book is highly priced, but useful.


... Read more

Product Description
Biotechnology is the applied science of using living organisms and their by-products for commercial development. It has grown and evolved to such an extent over the past few years that increasing numbers of professionals work in areas directly impacted by it. For the first time, this book offers an exciting and colorful overview of biotechnology for professionals and students in a wide array of the life sciences including: Genetics, Immunology, Biochemistry, Agronomy, Food Science, and Animal Science. This book also appeals to the lay reader without a scientific background who is interested in an entertaining and informative introduction to the key aspects of biotechnology.

Authors Renneberg and Demain discuss the opportunities and risks of individual technologies and provide historical data in easy-to-reference boxes, highlighting key topics. Biotechnology for Beginners covers all major aspects of the field, from food biotechnology to enzymes, genetic engineering, viruses, antibodies, and vaccines, to environmental biotechnology, transgenic animals, analytical biotechnology, and the human genome. This stimulating book is the most user-friendly source for a comprehensive overview of this complex field.

* Accessible to the lay reader without scientific background knowledge
* Coverage includes all facets of biotechnology applications
* Includes articles from the hottest Scientists: Alan Guttmacher, Carl Djerassi, Frances S. Ligler, Jared Diamond,Susan Greenfield, and more
* Each chapter concludes with a summary, annotated references, links to useful Web sites, and appealing review questions
* More than 600 color figures and over 100 illustrations
* Written in an enthusiastic and engaging style unlike other existing theoretical and dry-style biotechnology books ... Read more

Customer Reviews (6)

Excellent book. A must read.
I have just ended to read the book: Prof. Renneberg has written a masterpiece. This book is complete, well written, rich of marvelous figures and, very important, the book is strongly didactic. All the aspects of the modern biotechnology are covered.
I really suggest this book to anyone that wants to learn about modern biotechnology: she/he will not be disappointed. The reading of this book is really pleasant.
Thanks to Prof. Renneberg.

A book for all who want to know what Biotechnology really is
The book "Biotechnology for Beginners" contains a treasure of knowledge for this interdisciplinary area of science, which makes it a unique book. The multitude of scientific areas making up biotechnology has made it a very hard subject to cover in a comprehensible way in a volume that is not too heavy, both physically and reading it. Many textbooks on Biotechnology are biased with too much molecular biology, forgetting that Biotechnology is so much more, which is shown with abundance in this volume. In this book the use of recombinant DNA is integrated in almost all of the chapters, and then it becomes relevant.The book is well suited for students as an introduction into biotechnology, and also for journalists, policy makers, governmental workers and others that get in contact with the wonderful world of microorganisms and higher cells, and what these are able to do for each of us.

On 360 pages the author and editor give a up to date survey of most of the core areas in which biotechnology has made such a crucial impact on our daily lives.The book is generously illustrated and has very useful "boxes" to cover specific subjects from a historical perspective and they are full of unique information. The whole book is filled with facts, some usually not found in textbooks on Biotechnology. So even though I have been in the field for over 25 years, I found a lot of new information.

It must also be said that there are things to improve, hopefully for the 2nd edition. Specifically there are terms that are used without an explanation. To solve this I suggest a glossary at the start of each chapter with explanation of the key words used in the chapter.Just an example, on page 33 the words enthalpy and non-competitive inhibition are used but not explained whereas hydrophilic and hydrophobic are. There are more cases like this and a glossary would solve this problem.Another problem is that to comprehend some parts of the text you need to have some background knowledge in science, specifically biochemistry, and hopefully today's students have that.

A short remark on the spelling of the synonym for bioreactor. A fermenter is an organism which carries out the process of fermentation. A fermentor is a large growth vessel used to culture microorganisms on a large scale, frequently for the production of some commercially valuable product. In this book fermenter is used for bioreactor throughout. There are also other spelling mistakes which should be corrected in an eventual 2nd edition.

Stefan Rokem
Department of Molecular Genetics and Biotechnology
The Hebrew University of Jerusalem
Israel

A sociologist's view
It is often a problem to find books that help you understand the scientific and technical intricacies of a new phenomenon and at the same time shows its historical and social background. Reinhard Renneberg's Biotechnology for Beginners is the best introduction that I have read recently which achieves this purpose eminently. Renneberg takes you on a tour of biotechnology from its origins in fermentation via gene technology to the development of transgenic animals and analysis of the human genome. His core presentation focuses on the scientific explorations and technological achievements, but the supplementary illustrations and boxes presenting historical developments, critical issues or expert opinions enliven the text. Each chapter is also provided with list of recommended literature and websites, together with self-test questions and other aids for discussion of critical issues.

Many popular books on biotechnology tend to engage in partisan discourse on the merits or dangers of the technology, or they try to avoid the controversial issues altogether. Renneberg in my view strikes a good balance, drawing upon many sources of information and opinion.
As a sociologist and historian of science and technology, I am fascinated with the way that he has woven history and persons (and other living organisms) into the presentation of basic facts. In a sense, he complements technical detail with interesting facts about history and social applications in a way that resembles a double helix. The effect is awesome...

Can't agree with 1st review
I can't agree with the reviewer above who faulted the translation of the book into `Germlish'. There is no way that reader has to translate each sentence into `true English' as it reads very clearly to me. However, I would agree that the text is a little dry and as such is not as accessible as it could be. I also think the book is more appropriate for undergrad students than for graduates.

Cheers!
Science is fun.
Science must make dreams come true, but dreams are images.
Most textbooks forget fun and kill dreams; until now.
Reinhard Renneberg breaks the silencing wall of boredom, boringness, and blindness. His textbook is as funny as a manga, as exciting as Indiana Jones, as titillating as Gustave Klimt, and full of bouquet like a Chateau Latour 1982.
Cheers & Bravo!
... Read more

Product Description
Throughout history, humankind has pursued means to improve the yield of crop plants through selective plant breeding and hybridization. Today, genetic manipulation provides a powerful tool for directing plant breeding. But how is genetic manipulation implemented? What benefits can it offer? And what are the broader issues surrounding the use of this technology?

The second edition of Plant Biotechnology: The Genetic Manipulation of Crop Plants presents a balanced, objective exploration of the technology behind genetic manipulation, and the application of this technology to the growth and cultivation of plants. The book describes the techniques underpinning genetic manipulation in a clear, lucid manner, and this influential tool is used in practice.
... Read more

Product Description
The Business of Biotechnology is an abridged edition of Building Biotechnology, a more advanced book widely used in biotechnology courses. This streamlined version presents a broad, accessible, and comprehensive overview of the business of biotechnology. The elements shaping the industry are defined and explained, enabling you to understand and profit from the expanding influence of biotechnology. ... Read more

Product Description
This important volume commences with an overview of the modes of action of defensive secondary metabolites, followed by detailed surveys of chemical defense in marine ecosystems, the biochemistry of induced defense, plant-microbe interactions and medical applications. A chapter is also included covering biotechnological aspects of producing valuable secondary metabolites in plant cell and organ cultures. This is a comprehensive and fully updated new edition, edited by Professor Michael Wink and including contributions from many internationally acknowledged experts in the field. ... Read more

Product Description
Protein Biotechnology and Biochemistry is a complete and definitive source of information for all those interested in the area, providing a broad overview of the various medical, diagnostic and industrial uses of proteins. It covers basic biochemical principles as well as providing a comprehensive survey of products currently available or under development.

• The new edition has been thoroughly updated with new material.
• The key difference is that this new edition will include more "pure" biochemistry.
• There are two completely new chapters: Protein Structure - an overview and Novel Proteins from Novel Sources.

... Read more

Product Description
Some of humankind's greatest tools have been forged in the research laboratory. Who could argue that medical advances like antibiotics, blood transfusions, and pacemakers have not improved the quality of people's lives? But with each new technological breakthrough there comes an array of consequences, at once predicted and unpredictable, beneficial and hazardous. Outcry over recent developments in the reproductive and genetic sciences has revealed deep fissures in society's perception of biotechnical progress. Many are concerned that reckless technological development, driven by consumerist impulses and greedy entrepreneurialism, has the potential to radically shift the human condition - and not for the greater good. "Biotechnology and the Human Good" builds a case for a stewardship deeply rooted in Judeo-Christian theism to responsibly interpret and assess new technologies in a way that answers this concern. The authors jointly recognize humans not as autonomous beings but as ones accountable to each other, to the world they live in, and to God.They argue that to question and critique how fields like cybernetics, nanotechnology, and genetics might affect our future is not anti-science, anti-industry, or anti-progress, but rather a way to promote human flourishing, common sense, and good stewardship. A synthetic work drawing on the thought of a physician, ethicists, and a theologian, "Biotechnology and the Human Good" reminds us that although technology is a powerful and often awe-inspiring tool, it is what lies in the heart and soul of who wields this tool that truly makes the difference in our world. ... Read more

Customer Reviews (2)

We can...but should we?
Biotechnology and the Human Good is an important work by experts in their respective areas. The world is changing at breakneck speeds. We can now do things with the human body thought impossible a generation ago. There has been an explosion of genetic information. But the ever important, though muted question in our culture, is should we? This book offers solid, carefully reasoned advice for a way forward in a manner that treats all people with dignity and respect. Highly recommended!

Welcome to College: A Christ-Follower's Guide for the Journey

Essential for college-level science libraries
Great scientific and technological advancements benefiting mankind have come from biotech labs - but also some of the greatest ethical concerns have accompanied them, unfortunately. BIOTECHNOLOGY AND THE HUMAN GOOD charts the latest arguments over recent developments in reproductive and genetic science, building a case for stewardship routed in Judeo-Christian theism. What is science's responsibility in promoting the greater good? BIOTECHNOLOGY AND THE HUMAN GOOD is essential for college-level science libraries; particularly those interested in some of the religious foundations of bioethical concerns. ... Read more

Product Description
In this volume, leading scholars tackle the debate over intellectual property rights in high-technology industries and express their views on how to improve the current system. ... Read more

Product Description
In response to the field's need for an introductory text, theauthors have distilled the vast and scattered literature relating tothebiotechnology of microbial secondary metabolites. Generalbiology,biosynthesis, the search for novel metabolites, andtechniques forstrain improvement are all discussed to provideundergraduate andgraduate students with a concise, readable overviewof the field. ... Read more

Product Description
This book offers a comprehensive review of the prospects for a wide range of food ingredients produced using biotechnology. ... Read more

Product Description
Biotechnology Entrepreneurship: From Science to Solutions fills a critical gap in the biotechnology industry. For all the resources on how to start companies and on how to manage established companies in other sectors, there is a dearth of material on unique and critical issues in starting biotechnology companies, as well as managing the transition from start-up to established company. It is to this gap that Biotechnology Entrepreneurship is directed.

Topics covered include:
o Why Start a Biotechnology Company?
o Company Formation and Organization
o Building Your Team
o Intellectual Property Protection Strategy
o Financing Your Company
o Partnering With Industry
o Licensing and Technology Transfer
o Regulatory Affairs
o Roadmap to Reimbursement and Access
o Working Toward a Successful Exit

By combining the voices of a diverse set of industry insiders with extensive experience in biotechnology commercialization, Biotechnology Entrepreneurship prepares nascent founders, managers, investors, and other biotechnology company stakeholders to position themselves and their companies for commercial success. ... Read more

Product Description
The third edition of the acclaimed Manual of Industrial Microbiology and Biotechnology reviews the newest techniques, approaches, and options in the use of microorganisms and other cell culture systems for the manufacture of pharmaceuticals, industrial enzymes and proteins, foods and beverages, fuels and fine chemicals, and other products. Readers will find a rich array of methods and discussions of productive microbial processes, with means for improving the organism, the process, and the product. Cell cultures based on both prokaryotic and eukaryotic organisms are examined, including thorough coverage of mammalian cell culture. Genetics, strain improvement, genetic engineering, and bioprospecting are discussed with regard to a wide variety of organisms and processes. Focusing on the latest advances and findings that have brought us to the current state of the art and science, this edition features an entire new section devoted to the microbial production of biofuels and fine chemicals, as well as a stronger emphasis on mammalian cell culture methods. Many chapters review the latest genomic and other "omics" approaches.The book covers new methods that enhance the capacity of microbes used for a wide range of purposes, from winemaking to pharmaceuticals to bioremediation, at volumes from micro- to industrial scale. The editors have enlisted a multidisciplinary group of experts to serve as authors, including microbial ecologists, physiologists, geneticists, biochemists, molecular biologists, and biochemical engineers. Their contributions are based not only on a thorough evaluation of the primary literature, but also on the authors' own invaluable firsthand experience in industrial microbiology and biotechnology. Readers will find significant new insights into the development of industrial microbiology and biotechnology processes and products.Key Features * Presents the state of the technology in the isolation and screening of microorganisms for the production of novel secondary metabolites and enzymes * Sets forth genetic and molecular genetic methods to improve the production of microbial products * Offers a broad range of methods to genetically engineer the biosynthesis of important industrial enzymes, proteins, and secondary metabolites * Describes the latest technology for the microbial production of fuels and fine chemicals * Brings readers fully up to date on the latest microbial, mammalian, and other cell culture methods ... Read more

Customer Reviews (1)

A good book
It is a good book for both new and experienced researcher in biosciences. Reading this book had exposed me to many areas and important findings related to biotechnology. And had been the first reference for me when Ifaced many difficult problems.

An excellent book to collect. ... Read more

Product Description
Here, the world's top experts impart their knowledge and experience, many in print for the first time. By considering developing country markets, this book is the first truly global guide to technology transfer, helping companies all around the world to avoid costly mistakes in product development and to recover investments quickly. Individual sections treat trade-related aspects of intellectual property rights, technology transfer in health and healthcare as well as in agriculture and the environment. ... Read more

Customer Reviews (1)

dated, but a good overview of the biz side of biotech
This is a book that was written in response to the initial flurry of "unlimited horizon" books about the possibilities of genetic engineering.I had read about 3 of them with increasing boredom, and was delighted to find one that actually took a more critical attitude than bland techno-boosterism.It is about the investment community, the drug approval process, and the difficulties of harnessing basic science for profit.

As such, it is a very useful book, though certainly has been superceded by others in the field. ... Read more

Product Description
The pace of progress in fermentation microbiology and biotechnology is fast and furious, with new applications being implemented that are resulting in a spectrum of new products, from renewable energy to solvents and pharmaceuticals

Fermentation Microbiology and Biotechnology, Second Edition builds on the foundation of the original seminal work, extending its reach to reflect the multidisciplinary and expansive nature of fermentation research and advancements. While retaining valuable information from the previous edition including a brief history of the industry, as well as an overview of instrumentation and fermentor design, fermentation kinetics, and flux control analysis, the second edition addresses numerous topics that have risen to prominence in the past few years.

New chapters explore the diverse array of microbial biosynthetic pathways currently used by the fermentation and pharmaceutical industries for the production of primary and secondary metabolites such as amino acids, vitamins, antibiotics, immunosuppressants, and anti-tumor agents. The authors also examine recent advances in enzyme and co-factor engineering and cell immobilization with respect to both novel drug development and improved yields from microbial processes.

Beyond pharmaceuticals, this volume considers the emerging role of fermentation in the conversion of renewable resources to fine chemicals, as well as its potential use in converting lignocellulosic waste to ethanol. In addition, readers will also discover new chapters devoted to discussions of industrial issues such as modeling and sensor technology, as well as supervision and control in the fermentation process.

The text is packed with examples and case studies from the industry, carefully chosen to illuminate and reinforce principles and methodology discussed in the chapters. Organized and written in a concise and lucid manner that requires only a general background in microbiology, this volume meets the needs ... Read more

Product Description
This book is a guide to the "big picture" of biotechnology law and business, presenting and analyzing the issues that arise throughout the life cycle of the biotechnology product. The book focuses primarily on the pharmaceutical field, from university research through the development process and into the marketplace.The aim of the book is to provide guidance to the biotechnology legal and business communities by providing a practical and integrated discussion of the many different topics that arise in developing biotechnology products. It is intended to be used by I.P. lawyers, FDA lawyers, business lawyers and biotech executives who want a concise introduction to the most fundamental issues in biotechnology law and business. ... Read more

Customer Reviews (2)

Excellent Overview
Some of the most exciting, complex and dynamic issues facing society today are found at the intricate and, at times, uncertain interface marking the rapidly evolving boundaries of law and biotechnology. Within the maelstrom defined by present day societal, ethical and scientific forces, the appropriate application and guidance of a well reasoned legal structure is critical to fostering and maintaining a biotechnology paradigm that is both functional and, on the whole, beneficial to mankind.Yet, while the present legal and regulatory framework has worked reasonably well in addressing the issues of the biotechnology industry to this point, the challenges facing the system are greater than ever before.Simply by picking up today's paper one is confronted by a litany of ethical (cloning, embryonic stem cells), regulatory (biogeneric legislation, genetic therapy) and economic/business (scope of intellectual property protection, reimbursement rates) issues that are often contentious, ill defined and overlapping. To appreciate the ramifications of these and other challenges facing the industry, it is necessary to understand the current structure as well as the source of future pressure points.Fortunately, Bob Bohrer's book, A Guide to Biotechnology Law and Business does an excellent job, both in explaining the many facets of the present legal and regulatory system governing the biotechnology industry and in exploring the open issues and forces that are influencing its evolution.

Lucid, intelligent, balanced and comprehensive, the book is written both for the professional in the industry and for the educated layman in something akin to a Scientific American format. As explained by the author "The book is intended to provide `the big picture' to everyone interested or involved in the biotechnology industry."As one in the industry, I find the Guide to be an admirable first line reference for areas in which I have a need for a detailed understanding but not a need to develop an expertise (e.g. regulatory matters).

Starting out with an interesting overview and using applied examples, the book quickly brings in the role of the legal system (and lawyers) in biotech lifecycle management and implementation of strategy.Following a short technical discussion of the scientific basis for biotech products are relatively detailed explanations of the university tech transfer process and the role of intellectual property in biotechnology.While going through the legal structure, both subjects are enlivened with practical examples that provide a "real world" feel and understanding much deeper (and less dry) than the typical legal treatise.The book then moves into the legal process concerning two of the more interesting "big picture" questions surrounding any business: how to get the money and how to make money.As one in the industry I can't tell you how much time, effort, blood and tears go into these efforts.Here the chapters on business strategy and biotech financing, again with practical illustrations, struck me as comprehensive and provided an excellent overview.This was followed by two very readable and complete descriptions of one of the more critical areas in biotechnology, the regulatory process.In what I found to be one of the most useful sections of the book, the chapters provide a relatively clear description of what has been a confusing legislative history and untangle the present web of overlapping regulations.Finally, the author concludes with a series of chapters on current ethical and regulatory issues that leave the reader contemplating where the industry is heading.


All in all a highly exciting and readable book for anyone interested in obtaining a detailed overview of the biotechnology industry.I would highly recommend it.

A disclaimer:I am a former law student of the professor's and a long time acquaintance. At the present I am an intellectual property attorney with a major biopharmaceutical company.

Great Resource
Professor Bohrer's Guide to Biotechnology Law and Business is a great resource for professionals that work in the junction of law and biotechnology.While it is a must read for those new to this area, it is also a great reference tool for seasoned professionals.This book fills an important need and should be in every biotechnology professional's reference library. ... Read more

Product Description
Focusing on all current applications, this book presents the various methods as well as their suitability and limitations for a specific question. One particular highlight is the presentation of all basic information on the structure of the relevant objects, thus allowing readers to choose the most suitable applications for any specific problem. They will also find in-depth background information on structure-function relationships, plus descriptions of sample preparations with respect to a particular technique and the necessary equipment.
The whole is rounded off with an overview of the future application potential for devices and applications of upcoming interest in biotechnology. ... Read more

Product Description

This popular textbook has been completely revised and updated to provide a comprehensive overview and to reflect all the latest developments in this rapidly expanding area. Chapters on the impact of molecular biology in the development of biotechnology have been fully updated and include the applications of molecular biology in the areas of drug design and diseases. There are also completely new chapters in developing areas such as genome technology, nanobiotechnology, regenerative medicine and biofuels. By presenting information in an easily assimilated form, this book makes an ideal undergraduate text.

Product Description
Unlike most Biotechnology textbooks, Dr. David P. Clark's "Biotechnology" approaches modern Biotechnology from a Molecular Basis, which grew out of the increasing biochemical understanding of physiology.Using straight forward, less-technical jargon, Clark manages to introduce each chapter with a basic concept, that ultimately evolves into a more specific detailed principle.This up-to-date text covers a wide realm of topics including forensics and bioethics using colorful illustrations and concise applications.

This book will help readers understand what molecular biotechnology actually is as a scientific discipline, how the research in this area is conducted, and how this technology may impact the future.

· Up-to-date text focuses on modern biotechnology with a molecular foundation
· Basic concepts followed by more detailed, specific applications
· Clear, color illustrations of key topics and concepts
· Clearly written without overly technical jargon or complicated examples ... Read more

Product Description
A general introduction to both the moral philosophy and fundamentals of genetics is enhanced throughout the text with section-specific introductions that address the particular philosophical and scientific challenges posed by the topic under consideration. Softcover. Hardcover available. ... Read more