Senin, 29 Juni 2015

! Free PDF Handbook of Immune Response Genes, by Tak W. Mak, John J. L. Simard

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The study of immunology encompasses a vast and ever-growing body of information that in some way or other incorporates most areas of medical biological research. As the body of information in the medical sciences continues to increase its rate of expansion, one of the greatest challenges to investigators will be to integrate this information in a manner that is intellectually fruitful and productive. Considering the intended scope of this text, we could not pretend to have gone too far toward achieving such an integration--and considering the pace of change, in its very best form a measured approximation of such lofty goals might be the most we could hope for. Nevertheless, in these pages we have sought to produce a collection of information that is at once concise and up-to-date regarding areas where important developments are impacting on the way we understand the vertebrate immune system. In addition, although the information is geared toward advanced study, we have discussed some basic elements and concepts that we hope make the text a useful resource for both the immunologist and the nonspecialist. The intention is to provide the researcher, clinician, or advanced undergraduate student with a brief ov- view of specific components of the immune system, and to provide a place from which to begin further detailed study if necessary. To this end, we made every effort to supply extensive referencing--although limitations in space prevented exhaustive or complete referencing in some cases.

  • Sales Rank: #5409702 in Books
  • Published on: 1998-01-31
  • Original language: English
  • Number of items: 1
  • Dimensions: 10.10" h x 1.10" w x 7.10" l, 2.00 pounds
  • Binding: Hardcover
  • 394 pages

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@ Ebook Predictability, Stability, and Chaos in N-Body Dynamical Systems (Nato Science Series B:)From Springer

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The reader will find in this volume the Proceedings of the NATO Advanced Study Institute held in Cortina d'Ampezzo, Italy between August 6 and August 17, 1990 under the title "Predictability, Stability, and Chaos in N-Body Dynamical Systems". The Institute was the latest in a series held at three-yearly inter­ vals from 1972 to 1987 in dynamical astronomy, theoretical mechanics and celestial mechanics. These previous institutes, held in high esteem by the international community of research workers, have resulted in a series of well-received Proceedings. The 1990 Institute attracted 74 participants from 16 countries, six outside the NATO group. Fifteen series of lectures were given by invited speakers; additionally some 40 valuable presentations were made by the younger participants, most of which are included in these Proceedings. The last twenty years in particular has been a time of increasingly rapid progress in tackling long-standing and also newly-arising problems in dynamics of N-body systems, point-mass and non-point-mass, a rate of progress achieved because of correspondingly rapid developments of new computer hardware and software together with the advent of new analytical techniques. It was a time of exciting progress culminating in the ability to carry out research programmes into the evolution of the outer Solar 8 System over periods of more than 10 years and to study star cluster and galactic models in unprecedented detail.

  • Sales Rank: #6661612 in Books
  • Published on: 1992-01-31
  • Original language: English
  • Number of items: 1
  • Dimensions: 10.25" h x 7.00" w x 1.25" l, .0 pounds
  • Binding: Hardcover
  • 616 pages

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Minggu, 28 Juni 2015

!! Free Ebook Origami Card Craft: 30 Clever Cards and Envelopes to Fold, by Karen Elaine Thomas

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Origami Card Craft: 30 Clever Cards and Envelopes to Fold, by Karen Elaine Thomas

In the time it takes to pick out a card at the store, you can fold a beautiful, handmade card specifically designed for your special someone.

With Origami Card Craft, you can impress your friends with origami-inspired cards, boxes, and envelopes that pop up, fan out, and even hold hidden messages. Wow your sweetie with the Fold-Out Heart card or give a thank you to be remembered with the Pinwheel card. Here you’ll also learn to make five different envelopes to store and protect your creations. With over 25 years of experience in origami and paper crafting, author Karen Elaine Thomas shows you how easy it is to create unique cards out of folded paper, and gives you the skills necessary to read any origami pattern, in any language. With a few basic techniques under your belt and the endless opportunities that paper offers, there’s no limit to the dazzling cards you can create simply and quickly.

  • Sales Rank: #629406 in Books
  • Brand: Thomas, Karen Elaine
  • Published on: 2009-03-17
  • Released on: 2009-03-17
  • Original language: English
  • Number of items: 1
  • Dimensions: 10.85" h x .49" w x 8.59" l, 1.48 pounds
  • Binding: Paperback
  • 128 pages

About the Author
KAREN ELAINE THOMAS is the creative director for Yasutomo and Company. In addition to being involved in product development and education, she teaches paper crafts workshops at national trade shows and retail stores and has been a regular guest on HGTV’s Carol Duvall Show, the DIY Network, and www.crafttvweekly.com. The author of several craft books, Thomas has had her work featured in American Artist, Rubber Stamper, and Paper Crafts. Visit her at www.karenelaine.com and www.origamicardcraft.com.

Most helpful customer reviews

34 of 36 people found the following review helpful.
Paper foldng
By Judith P. Williard
I chose this book to make interesting card and scrapbook pages as well as a new craft to "play" with. The first use was for reserved seating notifications for our daughter's wedding. Guests were quite taken with the folded letter. Then I took the book and some paper to the nursing facility where my mom lives. She used to sew and quilt a lot so I thought I would try some techniques with her. Even though she has dementia, we accomplished two projects and will do more. She is very proud of her work and shows it to everyone. She says it helps keep her hands and mind active. So we are now planning new ways to use our projects when she and I make them - gifts of note cards, fun designs, etc.

15 of 15 people found the following review helpful.
Love it!
By A. Burke
I've only tried a few of these so far, and they've been successful, but the few I've learned are so useful, that they are worth the price of the book alone. And I have found inspiration for other projects as well looking through the pages. I stopped doing origami for a long time, because after all the figuring and folding, I rarely had any use for the objects created - not to mention the ROOM to keep and display them. But these things are useful as well as elegant. I may never buy another greeting card (which is a good thing, because greeting cards have become quite boring of late.) I can now combine collage, calligraphy, & illustration with paper folding. I know I am going to love it.

16 of 17 people found the following review helpful.
A few problems. . .
By C. Henry
The book is nicely produced and packaged, and the photos and directions are pretty good. However, I had problems folding a few of these things--I followed the instructions to the letter but wasn't satisfied with the results. I emailed the author asking for help with the problems I encountered but never had a reply. I agree with another reviewer that though the book is probably fun for newbies, many of the projects are identical to those in other books. But, there are some fun projects.

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Sabtu, 27 Juni 2015

? Free PDF The very best picnic (A First Little Golden Book), by Eugenie

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On the day of her picnic outing, Jessie becomes sick and has to stay in bed, but Mom finds a way to cheer her up.

  • Sales Rank: #2203980 in Books
  • Published on: 1988
  • Ingredients: Example Ingredients
  • Number of items: 1
  • Binding: Hardcover

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Kamis, 25 Juni 2015

** PDF Download Tony Aspler's Cellar Book: How to Design, Build, Stock and Manage Your Wine Cellar Wherever You Live, by Tony Aspler

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Tony Aspler's Cellar Book: How to Design, Build, Stock and Manage Your Wine Cellar Wherever You Live, by Tony Aspler

Tony Aspler returns with a book for anyone who has fallen under the spell of the glorious grape — and dreamed of having their very own wine cellar.

Tony Aspler’s Cellar Book provides guidelines for anyone, whether their regular tipple is a $15-Australian or a $100-Bordeaux, who wants to keep a supply of wines that will age with grace and flavour and be ready to consume for a mid-week dinner or a spontaneous celebration. Tony’s suggestions for general approaches to establishing a cellar, specific bottles and even themes will help you create the perfect collection — big or small. Basic techniques for evaluating the right cellar for your needs are accompanied by sidebars of cellaring experience and advice from well-known wine celebrities. Follow Tony as he builds his own cellar in his condo, while picking up tips on how to build your own.

  • Sales Rank: #2620831 in Books
  • Published on: 2009-10-27
  • Released on: 2009-10-27
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.51" h x 1.18" w x 6.39" l, 1.45 pounds
  • Binding: Hardcover
  • 352 pages

Review
“Tony has a profound understanding of our wine industry, a meticulous eye for detail and a clarity of thought that translates beautifully onto the page.”
— Natalie MacLean

“Tony writes about wine with love, warmth, knowledge and a sense of humour. Enjoy.”
— Bonnie Stern

About the Author
Tony Aspler has been writing about wine for more than thirty years and today he is the most widely respected wine writer in Canada. He was been the wine columnist for the Toronto Star for over twenty years and has authored eleven books on wine and food. He writes for a number of international wine magazines and is involved in several charities. He lives in Toronto.

Excerpt. © Reprinted by permission. All rights reserved.
WHY WINE NEEDS CELLARING
 
Wine is a difficult and finicky house guest. We're lucky that wine doesn't have its own voice; otherwise, it would spend most of the time complaining and we would have to send it for professional counselling. It would always be going on about something or other. Wine gets "bottle shock" when first introduced to the container in which it will spend its life, rather like an unsuccessful first date that turns into a lock-down arranged marriage. Wine doesn't like to travel and has to rest several weeks on arrival at its destination before it gets back its mojo (balance). It has no desire to go to Florida for the winter; it doesn't like fluctuations of temperature or being jostled by vibrations from machines (clothes dryers, compressors, dishwashers, elevators, trains, subways or passing traffic, etc.). It abhors bright light and heat and does not like the smell of paint, solvents, detergents or household refuse (strong odours can, over time, seep through the cork and affect the flavour of the wine). Given its finicky disposition, wine, if truth be told, probably suffers from agoraphobia: if those bottles in your basement had their way they would rather be slumbering in the dark, damp cellar where they were born and would not have to travel at all. But life is hard, and wines, like pets, are there for our enjoyment. And, like pets, wine responds best to kindly treatment rather than benign neglect or abuse.
 
My heart bleeds when I see where some people store their wines. I have been in kitchens that have wine racks installed over refrigerators, with bottles slowly cooking from the rising heat and being massaged into old age by the vibrations of the compressor. I have seen wines stored in terra cotta tubular tiles set into stone walls beside a fireplace in the den. I have seen wines stored in unheated attics that bake in summer and freeze in winter— rather like Madeira lodges, which encourage the oxidation of their wines this way. And I have to confess that my own parents used to keep the single ceremonial bottle of Manischewitz in the linen closet, at a temperature above the thermostat setting in the living room. So be kind to your wine. It will reward you for your concern.
 
Wine, like human beings, begins to die the moment it's first exposed to air. Sad but true. It's all a matter of time, and some of us live longer than others. Like us, all wines do not age at the same rate; some, because of their grape variety and their conditions of growth (soil, heat, length of time on the vine, extract, balance of sugar and acidity, winemaking technique and storage), will live longer than others. I have tasted wines that were over a hundred years old and still gave pleasure. On the other hand, I have tasted young wines that had become old before their time, dried out, lost colour, yet were still corseted with tannins.
 
In white wines it is the acid that gives wine its structure and its ability to age; think of acid as the skeleton of the wine, the frame that supports the fruit. In reds it's the phenolics— colouring matter in the skins and tannins from the skins, pits and stalks— that preserve the wine. Tannins are that bitter compound you experience when you bite into a grape pit or stalk or chew on a grape skin. In the leather industry they use tannic acid to preserve hides. There is tannic acid in wine that has the same preservative effect. When a wine ages, the tannins soften and will ultimately, after several years, precipitate as a sediment with colouring matter. The bouquet becomes more complex and the fruit begins to dry out. Red wines lose their colour as they age, while white wines, ironically, become deeper in colour.
 
The good news is that most red wines will get better with some bottle age— except Beaujolais Nouveau and rosés, which are made to be consumed within a year of their vintage date. I wish there were a mathematical formula that could tell you when a wine had reached its peak of maturity, but there isn't, and so we have to go by rough guesses. In my experience red Bordeaux is the most difficult wine to predict when to open. At three years after the vintage date it can taste lively and fruity behind its gripping tannins; a year or two later it can close down and go "dumb" before it opens up again after another three or so years' cellaring. That's why it's worth buying a case of a Bordeaux château you like and opening a bottle every year to try and catch it at its pleasure peak.
 
The quality growth of a wine is not a bell curve; it's more a jagged line that rises to a point, then plateaus for a year or two before going into decline as the fruit begins to dry out. As red wines age their acidity softens and the tannins and colouring matter begin to precipitate. That's why you see sediment in bottles of mature wines. The bouquet also changes, becoming more pronounced, losing its fruity fragrance and developing more organic nuances of chocolate, coffee beans or leather. Really old wines develop tertiary bouquets of soy, balsamic vinegar and stewed fruits. That's why grapes that are high in tannin produce cellar-worthy wines. The major varieties are
 
• Cabernet Sauvignon (especially from cooler regions like Bordeaux)
• Cabernet-Merlot blends (Meritage)
• Nebbiolo-based wines (Barolo/Barbaresco)
• Syrah/Shiraz (Rhône, Australia)
• Tempranillo (Spain)
• Sangiovese (Italy).
 
Cabernet Sauvignon is king when it comes to tannins, because of its small berry size. This means that the ratio of skin to pulp is high, and since tannins are concentrated in the skins as well as in the pits and stalks, the resulting wine will be higher in tannin than, say, Merlot, which has a larger berry size.
 
While some white wines can benefit from cellaring for up to a decade, most should be consumed within a year of their vintage date. The exceptions are domaine-bottled white Burgundy (never inexpensive); Chenin Blanc from the Loire Valley; Rieslings from cool-climate regions such as Germany, Austria and Ontario; some Rioja whites and sweet dessert wines (sugar is a great preservative) with good acidity (for example, Sauternes, Tokaji, icewine); and vintage-dated champagne.
 
Fortified wines such as port, sherry, Madeira and Marsala are the "no-brainer" cellar choices. They have inherent longevity because of their higher alcohol content (20 to 22 percent by volume), which acts as a preservative along with the residual sugar and acidity.
 
Generally— though I hate to admit it— the more you pay for a wine the more likely it will age well.

Most helpful customer reviews

2 of 2 people found the following review helpful.
Not what I thought
By Barry Munson
I wanted to build a wine cellar in a 2'x3' interior closet space in my house in Southern California. The following line in the description convinced me to buy this book, "Follow Tony as he builds his own cellar in his condo." Actually, Tony does not build a cellar in his condo, he builds it in his condo complex. He obtains the rights to convert a rather large space detached from his actual living space. Further, he lives in Canada where freezing is a major concern in the construction details. He is trying to keep his wine from freezing, I am trying to keep my wine from boiling. The actual construction details were minimal, little use to me. I give it 3 stars because the rest of the content, mostly about wine, and not wine storage, was somewhat thorough.

0 of 0 people found the following review helpful.
A good read, covers the basics.
By Darb
Good realistic reading for those that want to build a wine cellar. I have several books on this subject, and most cover the basics. This one goes a little deeper and is a good read.

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Rabu, 24 Juni 2015

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Volume 4 of Contemporary Nephrology summarizes major advances in 16 different areas of nephrology during the years 1985 and 1986. Major changes in the composition of the Editorial Board and authorship of the different chapters have occurred in this volume. Six distinguished contributors have retired from the Editorial Board. They include Dr. Zalman A. Agus, Philadelphia; Dr. Robert Anderson, Denver; Dr. Eli Friedman, Brooklyn; Dr. Richard Glassock, Torrance, California; Dr. James Schafer, Birmingham, Alabama; and Dr. Gordon Williams, Bos­ ton. We are grateful to them for their outstanding contributions to the of this series and for their advice and suggestions as first three volumes members of the Editorial Board. They certainly deserve substantial credit for the success of this series. Seven outstanding academicians have joined the Board. They in­ clude Dr. Vito M. Campese, Professor of Medicine at the University of Southern California, who contributed the chapter on "Recent Advances in the Role of the Renal Nervous System and Renin in Hypertension"; Dr. William G. Couser, Professor of Medicine and Head of the Division of Nephrology at the University of Washington in Seattle ("Immunologic Aspects of Renal Disease"); Dr. Garabed Eknoyan, Professor of Medicine and Vice Chairman of the Department of Medicine at Baylor College of Medicine ("The Uremic Syndrome"); Dr. H. David Humes, Associate Professor of Medicine and Chief of the Nephrology Section at the Uni­ versity of Michigan Medical School, Veterans Administration Medical Center ("Acute Renal Failure and Toxic Nephropathy"); Dr.

  • Published on: 1987-08-01
  • Original language: English
  • Number of items: 1
  • Dimensions: .0" h x .0" w x .0" l, .0 pounds
  • Binding: Hardcover
  • 774 pages

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Selasa, 23 Juni 2015

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  • Sales Rank: #14412054 in Books
  • Published on: 1984-03-31
  • Original language: English
  • Number of items: 1
  • Dimensions: .0" h x .0" w x .0" l, .0 pounds
  • Binding: Hardcover
  • 274 pages

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  • Sales Rank: #1335538 in Books
  • Published on: 2011-02-08
  • Released on: 2011-02-08
  • Original language: English
  • Number of items: 1
  • Dimensions: 6.73" h x .30" w x 4.80" l, .25 pounds
  • Binding: Paperback
  • 48 pages
Features
  • Boston, USA
  • Travel Book
  • Fold-Out Maps
  • Travel Guide

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2 of 2 people found the following review helpful.
great little guide!
By A. Bull
I recently moved to MA and needed a quick reference guide for Boston. This guide fits the bill, great lay out! The only improvement I could think of is coating the maps with something to make them more durable. This little guid easily fits into a purse or even a coat pocket and no more unfolding huge maps!

0 of 0 people found the following review helpful.
Disappointing...poorly done.
By lmp
I always get a Knopf Mapguide prior to visiting any large city...I find them very helpful especially for walking the various neighborhoods of cities I visit. The one for Boston is a disappointing exception. Adjacent map numbers on the perimeter of the active page are not included.. I could deal with that.
But not with the omission of sections of neighborhoods. For instance, you cannot see the street where the USS Constitution is moored. You cannot see the bridge that connects Beacon Hill to Cambridge. The entire neighborhood of Eastern Cambridge, where the western end of that bridge is located [as is Kendall Square], is entirely omitted. The map for the South End cuts off abruptly omitting the streets where the Cathedral of the Holy Cross is located. I find all this very frustrating and will have to look for another map.

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Love this map/guide!
By Cheryl N.
When we are planning a trip, this is the first purchase we make. My husband and I research and notate the places we want to see and eat in our MapGuide. Often, this is the only book and/or map that we carry when we are out exploring. Each day we explore a different part of the city, using the maps to plan our route for the day. We love how it is compact and how it highlights the main attractions in each area. We have already purchased several of these. We love looking at our bookshelf and seeing these as reminders of the cities that we have traveled to.

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Sabtu, 20 Juni 2015

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Author Henry D. Schlinger, Jr., provides the first text to demonstrate how behavior analysis-a natural science approach to human behavior-can be used to understand existing research in child development. The text presents a behavior-analytic interpretation of fundamental research in mainstream developmental psychology, offering a unified theoretical understanding of child development. Chapters examine mnemonic, motor, perceptual, cognitive, language, and social development.

  • Sales Rank: #315619 in Books
  • Published on: 1995-10-31
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.21" h x .69" w x 6.14" l, 1.33 pounds
  • Binding: Hardcover
  • 264 pages

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Kamis, 18 Juni 2015

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Chemists' Views of Imaging CentersFrom Springer

To continue the support for the growing trend of chemistry involvement in nuclear medicine, the Division of Nuclear Chemistry and Technology (DNCT) of the American Chemical Society (ACS) planned for a symposium to cover this aspect. This was expressed in arequest to me, as a member of the Program Committee, to organize a symposium on topics related to nuclear and radiochemistry applications to nuclear medicine. Realizing the growing interest in imaging, specially with positron emitting radioisotopes, I invited several colleagues to study with me the idea of imaging centers and the involvement of chemists in their structure and function. The formulated Organizing Committee supported this idea which evolved in proposing an extended international symposium to be held in conjunction with the 206th ACS National meeting in Chicago, Illinois, U. S. A. on August 22-27, 1993. The following are the members of the Organizing Committee: Jorge R. Barrio, Ph. D. Thomas E. Boothe, Ph. D. J. Robert Dahl, Ph. D. Robert F. Dannals, Ph. D. Bruce R. Erdal, Ph. D. Mark M. Goodman, Ph. D. George W. Kabalka, Ph. D. James F. Lamb, Ph. D. Ronald G. Manning, Ph. D. Henry C. Padgett, Ph. D. Roy S. Tilbury, Ph. D. Steven W. Yates, Ph. D. and Ali M. Emran, Ph. D.

  • Sales Rank: #17305657 in Books
  • Published on: 1995-08-31
  • Original language: English
  • Number of items: 1
  • Dimensions: 9.21" h x 1.25" w x 6.14" l, 2.09 pounds
  • Binding: Hardcover
  • 538 pages

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Rabu, 17 Juni 2015

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A retelling of Dickens's ghost story with Mickey Mouse, Donald Duck, and other Disney creations depicting the original characters.

  • Sales Rank: #2745602 in Books
  • Published on: 1999-12-31
  • Released on: 1999-12-31
  • Original language: English
  • Dimensions: 11.25" h x 8.50" w x .50" l,
  • Binding: Hardcover
  • 22 pages
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Selasa, 16 Juni 2015

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"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post­ market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.

  • Sales Rank: #2860248 in Books
  • Published on: 2003-12-31
  • Original language: English
  • Number of items: 1
  • Dimensions: 10.00" h x .88" w x 7.01" l, 1.85 pounds
  • Binding: Hardcover
  • 350 pages

From the Back Cover

An effective CMC regulatory compliance strategy for biologics and biopharmaceuticals can seem like a mystery.  Through means of this 2nd edition, this no longer needs to occur.  A great deal of thanks goes to two regulatory authorities – the United States Food and Drug Administration (FDA) and the European Medicines Agency (EMA), who provide through their respective websites, an abundance of guidance, especially in the last several years.  So much has changed since the 1st edition of this book was published in 2004.  There are now additional manufacturing processes for producing commercial biopharmaceuticals – transgenic plant cell cultures and transgenic animals.  In addition to commercial recombinant proteins and monoclonal antibodies, there are now commercial cell-based medicines (cellular therapy) and DNA-based medicines (gene therapy).  Biosimilars are now on the marketplace in Europe, and under review for commercial approval in the USA.  Vaccine manufacturing has resurged due to the concerns of potentially pandemic mutated animal influenzas (e.g., swine flu, bird flu).  Strategic international regulatory guidances have been adopted that are driving the entire pharmaceutical industry, including biopharmaceuticals, to a higher standard of performance, including Quality by Design (QbD), Quality Risk Management (QRM) and Pharmaceutical Quality Systems (PQS).  The vast majority of the over 600 regulatory references listed in this book were either issued or updated since the release of the 1st edition.  All of these changes are the reason this updated edition includes not only biopharmaceuticals but also other biologics (e.g., live virus vaccines, human plasma-derived proteins, cell-based medicines, natural-sourced proteins) that have CMC regulatory compliance concerns and challenges in common with the genetically-engineered biologics (i.e., the biopharmaceuticals). 

 

 

About The Author

 

John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.  Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry.  Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee.  Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).

About the Author

John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry.  Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry.  Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee.  Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).

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0 of 0 people found the following review helpful.
Great resource for someone new to biologics
By Reg Affairs Gal
I recommend this book for anyone involved in development, compliance, and regulatory activities of biopharmaceuticals. It's a solid reference book that walks you through the BLA submission requirements for different types of biologics/ biopharmaceuticals (e.g., rDNA, MoAb, gene therapy). It includes some examples of these sections but I wish there were more. The book does not go into much detail about Quality by Design - there are other good reference books for that topic. Also, don't expect glossy figures or diagrams. Consider this book the equivalent of a $1500-$2000 short course for ~$140!

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