Sign-In
Cart
Biological Drugs Two Volume Set
Other
Series: Drugs and the Pharmaceutical Sciences
Medical ReferenceTechnology & EngineeringBiology
Currently unavailable to order
Please enter your email and a message will be sent to you when this product becomes available on our website.
ISBN13: 9781041462590
Publisher: CRC Press
Language: English
Biological drugs have revolutionized modern medicine, providing highly effective therapies for cancer, autoimmune diseases, genetic disorders, infectious diseases, and many other serious conditions. Their successful development, however, requires mastery of complex scientific principles, advanced manufacturing technologies, and an increasingly demanding global regulatory environment. This volume provides a comprehensive, practical guide to the development of both innovative biological products and biosimilars, covering every stage from product design and process development to manufacturing, quality assurance, regulatory submission, and commercialization.
Drawing upon decades of scientific, industrial, and regulatory experience, the book explains how to establish efficient development strategies that reduce time, cost, and technical risk without compromising product quality or regulatory compliance. Numerous examples of electronic Common Technical Document (eCTD) submissions, development plans, manufacturing workflows, and regulatory documentation illustrate internationally accepted best practices and demonstrate how sound scientific principles can be translated into successful product development.
Comprehensive appendices summarize the regulatory dossiers and development pathways for virtually every major class of approved biological drugs, providing practical guidance for selecting appropriate development strategies and preparing scientifically justified submissions. Particular emphasis is placed on distinguishing essential regulatory expectations from unnecessary studies and common misconceptions that frequently increase development costs and delay market entry.
Combining scientific depth with practical implementation, this volume serves as an authoritative reference for scientists, engineers, manufacturers, regulatory professionals, biotechnology entrepreneurs, and graduate students engaged in the research, development, manufacture, and approval of biological medicines worldwide.
Key Features
- Outlines the history of technology and evolution of biological drugs, emphasizing the trends in the changes expected over the next two decades.
- Describes the development of novel biological drugs, types of drugs, their mode of action, the hurdles in identifying and developing them.
- Creates practical manufacturing processes with novelty in mind; for example, recombinant may soon be replaced by cell-free or mRNA? Detailed discussions of all technologies are provided.
- Discusses establishment of GMP-compliant manufacturing, from facility design to qualification with emphasis on multiple-use options.
- Provides examples of classes of biological drugs from therapeutic proteins to vaccines and gene therapies as well as examples of eCTDs for over 50 biological drugs.
Also from
Niazi, Sarfaraz K.
Biological Drugs Volume 2: Regulatory Strategies, Novel and Copies of Biological Drugs
Niazi, Sarfaraz K.
Paperback
Biological Drugs Volume 2: Regulatory Strategies, Novel and Copies of Biological Drugs
Niazi, Sarfaraz K.
Hardcover
Also in
Biology
The Age of Living Machines: How Biology Will Build the Next Technology Revolution
Hockfield, Susan
Paperback
Entangled Life: How Fungi Make Our Worlds, Change Our Minds & Shape Our Futures
Sheldrake, Merlin
Paperback
Hidden Creatures: Luscious Leeches, Bashful Botflies, and the Wondrous, History-Shaping World of Parasites
Martins, Dino
Hardcover
Beyond Inheritance: Our Ever-Mutating Cells and a New Understanding of Health
Khamsi, Roxanne
Hardcover
The Biology of Trauma: How the Body Holds Fear, Pain, and Overwhelm, and How to Heal It
Apigian, Aimie
Hardcover
The World Beneath Our Feet: The Hidden Life of Soil and Why It Matters to Us All
Ashwood, Frank
Hardcover
Go Forth and Forage: A Guide to Foraging Over 50 of the Most Common Edible & Medicinal North American Mushrooms
Johnson, Whitney
Paperback
History by a Hair: Thomas Jefferson, Sally Hemings & Solving a 200-Year-Old Mystery
Kurin, Richard
Hardcover
Forbidden Facts: Government Deceit & Suppression about Brain Damage from Childhood Vaccines
de Becker, Gavin
Hardcover
Togetherness: Symbiosis and the Hidden Story of Life's Greatest Collaborations
Hooper, Rowan
Hardcover
The Power of Life: The Invention of Biology and the Revolutionary Science of Jean-Baptiste Lamarck
Riskin, Jessica
Hardcover
Ernst Haeckel's Art Forms in Nature: A Visual Masterpiece of the Natural World
Haeckel, Ernst
Hardcover
Fungi Decoded: Adventures in the Mycosphere--Encounters with Thirty Fungi
Bunyard, Britt A.
Paperback
Food Intelligence: The Science of How Food Both Nourishes and Harms Us
Hall, Kevin, PhD
Belluz, Julia
Hardcover
The Whole Truth: The Hidden Agendas Behind Decades of Health Misinformation--And What to Do about It
Campbell, Nelson
Campbell, T. Colin
Hardcover
Night Magic: Adventures Among Glowworms, Moon Gardens, and Other Marvels of the Dark
Henion, Leigh Ann
Hardcover
Princeton Review AP Biology Premium Prep, 29th Edition: 6 Practice Tests + Digital Practice Online + Content Review
The Princeton Review
Paperback
Peterson Field Guide to Mushrooms of North America, Second Edition
McKnight, Karl B.
Rohrer, Joseph R.
McKnight Ward, Kirsten
Paperback
Cells at Work! Picture Book 1: The Great Bacteria vs. White Blood Cell Battle!
Makimura, Kumi
Hardcover
The Big One: How We Must Prepare for Future Deadly Pandemics
Olshaker, Mark
Osterholm, Michael T.
Hardcover
Bioinspired: How Nature Made Us Modern, Drives Today's Technological Innovation, and Inspires a Future Worth Inventing
Stier, Samuel Cord
Hardcover
A Year with the Seals: Unlocking the Secrets of the Sea's Most Charismatic and Controversial Creatures
Morris, Alix
Hardcover
VAX Facts: What to Consider Before Vaccinating at All Ages & Stages of Life
Thomas, Paul
Hoover, Deedee
Paperback
Psilocybin: Magic Mushroom Grower's Guide: A Handbook for Psilocybin Enthusiasts
Oeric, O. N.
Oss, O. T.
Paperback
All That Remains: A Renowned Forensic Scientist on Death, Mortality, and Solving Crimes
Black, Sue
Paperback
The Gut-Brain Paradox: Improve Your Mood, Clear Brain Fog, and Reverse Disease by Healing Your Microbiome
Gundry MD, Steven R.
Hardcover
The Aesthetic Revolution: Embracing Vanity and the Future of Fitness to Unlock Your Healthiest Self
Israetel, Mike
Hardcover
National Geographic the Photo Ark: One Man's Quest to Document the World's Animals
Sartore, Joel
Chadwick, Douglas H.
Hardcover
True Hallucinations: Being an Account of the Author's Extraordinary Adventures in the Devil's Paradis
McKenna, Terence
Paperback
Mushrooms of the Redwood Coast: A Comprehensive Guide to the Fungi of Coastal Northern California
Schwarz, Christian
Siegel, Noah
Paperback
Psilocybin Mushrooms: A Comprehensive Guide to Growing and Using Psychedelic Mushrooms
Madden, Michael
Paperback
Fungi of Temperate Europe: Keys to the Basidiomycotes
Petersen, Jens H.
Frøslev, Tobias G.
Læssøe, Thomas
Hardcover
The Life Machines: How Taking Care of Your Mitochondria Can Transform Your Health
Rosen, Emanuel
Mochly-Rosen, Daria
Hardcover
The Little Book of Mushrooms: An Illustrated Guide to the Extraordinary Power of Mushrooms
Dorr, Alex
Hardcover
Pull: How Gravity Shapes Your Body, Steadies the Mind, and Guides Our Health
Spiegel, Brennan
Hardcover
Entangled Life: How Fungi Make Our Worlds, Change Our Minds & Shape Our Futures
Sheldrake, Merlin
Hardcover
Mushrooming: An Illustrated Guide to the Fantastic, Delicious, Deadly, and Strange World of Fungi
Borsato, Diane
Hardcover
The Contagion Myth: Why Viruses (Including Coronavirus) Are Not the Cause of Disease
Fallon Morell, Sally
Cowan, Thomas S.
Hardcover
Mushrooms of Cascadia, Second Edition: An Illustrated Key to the Fungi of the Pacific Northwest
Beug, Michael
Paperback
Human Errors: A Panorama of Our Glitches, from Pointless Bones to Broken Genes
Lents, Nathan H.
Paperback
From These Lands: Sharing Our Natural and Cultural Heritage
National Museum of Natural History
Hardcover
The Ocean's Menagerie: How Earth's Strangest Creatures Reshape the Rules of Life
Harvell, Drew
Hardcover
How to Win Friends and Influence Fungi: Collected Quirks of Science, Tech, Engineering, and Math from Nerd Nite
Balakrishnan, Chris
Wasowski, Matt
Paperback
The Pale Blue Data Point: An Earth-Based Perspective on the Search for Alien Life
Willis, Jon
Hardcover
Field Notes from a Fungi Forager: An Illustrated Journey Through the World of Pacific Northwest Mushrooms
Rodriguez, Ashley
Hardcover
The Mycocultural Revolution: Transforming Our World with Mushrooms, Lichens, and Other Fungi
McCoy, Peter
Hardcover
Life in Sync: The Science of Internal Clocks and How We're Disrupting Them
Gander, Philippa
Hardcover
The Art and Science of Foodpairing: 10,000 Flavour Matches That Will Transform the Way You Eat
Lahousse, Bernard
Langenbick, Johan
Coucquyt, Peter
Hardcover
Gut Check: Unleash the Power of Your Microbiome to Reverse Disease and Transform Your Mental, Physical, and Emotional Health
Gundry MD, Steven R.
Hardcover
National Audubon Society Wildflowers of North America: The Complete Identification Reference to Wildflowers--With Full-Color Photographs; Updated Rang
National Audubon Society
Hardcover
Understanding Ampicillin: Understanding Ampicillin: Indications, Administration, And Drug Interactions
Caldwell, Ethan
Paperback
The Double Helix: A Personal Account of the Discovery of the Structure of DNA
Watson, James D.
Paperback
Sea Wonders: The Octopus, the Cuttlefish, and the Squid
Colombo, Marco
Tomasinelli, Francesco
Hardcover
Superconvergence: How the Genetics, Biotech, and AI Revolutions Will Transform Our Lives, Work, and World
Metzl, Jamie
Paperback
If the Ocean Has a Soul: A Marine Biologist's Pursuit of Truth Through Deep Waters of Faith and Science
Jordan, Rachel G.
Paperback
The Serengeti Rules: The Quest to Discover How Life Works and Why It Matters
Carroll, Sean B.
Paperback
Field Guide to Wild Mushrooms of Pennsylvania and the Mid-Atlantic: Revised and Expanded Edition
Russell, Bill
Paperback