Handbook Of Biological Therapeutic Proteins PDF Download
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| Author | : Sarfaraz Niazi |
| Publisher | : |
| Total Pages | : 0 |
| Release | : 2024 |
| Genre | : Medical |
| ISBN | : 9781003392026 |
Download Handbook of Biological Therapeutic Proteins Book in PDF, ePub and Kindle
"Since 1972 when recombinant engineering was invented, over 500 therapeutic proteins have been approved. Today, biological drugs constitute almost 70% of all new drugs and are of biological origin. The first edition of this book dealt with biosimilars, the second focuses on new drugs yet limits to therapeutic proteins. The newer technologies for development represent the updated topics in the book and include repurposing, AI-driven identification of newer designs, novel expression systems and manufacturing, fast changing regulatory pathways, and legal hurdles. Discusses how to identify, develop, manufacture and take multibillion dollar products to market in the shortest possible time"--
| Author | : Sarfaraz K. Niazi |
| Publisher | : CRC Press |
| Total Pages | : 592 |
| Release | : 2002-08-15 |
| Genre | : Medical |
| ISBN | : 1000611329 |
Download Handbook of Biogeneric Therapeutic Proteins Book in PDF, ePub and Kindle
More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulato
| Author | : Sarfaraz K. Niazi |
| Publisher | : CRC Press |
| Total Pages | : 584 |
| Release | : 2002-08-15 |
| Genre | : Medical |
| ISBN | : 9780849329913 |
Download Handbook of Biogeneric Therapeutic Proteins Book in PDF, ePub and Kindle
More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all the regulatory wrinkles yet to be ironed out, generic or similar biological products are soon to become a reality. Handbook of Biogeneric Therapeutic Proteins is the first book to review and analyze the status of biotechnology, regulatory environment, manufacturing methodologies, testing requirements and intellectual property issues. The book provides complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins and how to prepare detailed regulatory and manufacturing plans and policies. The author includes information on establishing a manufacturing system, securing regulatory approval, and setting up facilities to manufacture raw materials and prepare finished products. He also supplies details about the Chemistry, Manufacturing, and Controls (CMC) section of the FDA's New Drug Application for Biological Products. In brief, the book supplies everything a manufacturer would need to plan the development of biogeneric products and complete the process of regulatory filing. Waiting for the FDA to issue guidelines is a mistake. The scramble to catch up could leave your company way behind in the game. Your organization needs to begin developing and characterizing genetically modified cells now and to complete initial GMP production runs through a CRO to get ready for the newer testing the FDA might impose. Packed with tables and figures that provide speedy access to precise, timely data, including full formulation details on all FDA approved biological product, this book contains a broad range of resource materials about suppliers, manufacturers, and testing facilities. These features combined with the author's hands-on, practical approach give you the edge you need.
| Author | : Sarfaraz Niazi |
| Publisher | : CRC Press |
| Total Pages | : 413 |
| Release | : 2024-04-15 |
| Genre | : Medical |
| ISBN | : 1003860206 |
Download Handbook of Biological Therapeutic Proteins Book in PDF, ePub and Kindle
Since 1972, which marks the invention of recombinant engineering, more than 500 therapeutic proteins have been approved for clinical use. Today, biological drugs constitute almost 70% of all new drugs and have a biological origin. The first edition of this book dealt with biosimilars, and this edition (i.e., the second edition) focuses on new drugs, yet limits to therapeutic proteins. Newer technologies for drug development represent the updated topics in the book and include repur-posing, AI- driven identification of newer designs, novel expression systems, manufacturing using these systems, rapidly changing regulatory pathways, and legal hurdles. This edition discusses how to identify, develop, manufacture, and take multibillion dollar products to market within the shortest possible time. Features: Complete and thorough coverage of the regulatory and technological challenges of developing generic therapeutic proteins Comprehensive, discovery to market, newer technologies, regulatory planning and IP hurdles are included that are not found elsewhere Expanded volume that must be in the hands of every company interested in biological drugs, including the mRNA-based biopharmaceutical companies fast appearing on the market Discusses how to identify, develop, manufacture, and take multibillion dollar products to market in the shortest possible time Renowned author and entrepreneur in the field of drug discovery and production
| Author | : Tristan Vaughan |
| Publisher | : John Wiley & Sons |
| Total Pages | : 762 |
| Release | : 2017-12-04 |
| Genre | : Medical |
| ISBN | : 3527340866 |
Download Protein Therapeutics, 2 Volume Set Book in PDF, ePub and Kindle
Branchenführende Big-Pharma-Unternehmen und erstklassige Forscher präsentieren grundlegende Konzepte und Herausforderungen bei proteinbasierten Pharmazeutika. Beinhaltet auch eine Einführung in die aus Sicht der Arzneimittelentwicklung fünf wesentlichen Anwendungsbereiche.
| Author | : C. Mark Smales |
| Publisher | : Springer Science & Business Media |
| Total Pages | : 481 |
| Release | : 2008-02-04 |
| Genre | : Science |
| ISBN | : 1592599222 |
Download Therapeutic Proteins Book in PDF, ePub and Kindle
With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.
| Author | : Gauri Misra |
| Publisher | : Academic Press |
| Total Pages | : 188 |
| Release | : 2019-03-23 |
| Genre | : Medical |
| ISBN | : 0128172800 |
Download Data Processing Handbook for Complex Biological Data Sources Book in PDF, ePub and Kindle
Data Processing Handbook for Complex Biological Data provides relevant and to the point content for those who need to understand the different types of biological data and the techniques to process and interpret them. The book includes feedback the editor received from students studying at both undergraduate and graduate levels, and from her peers. In order to succeed in data processing for biological data sources, it is necessary to master the type of data and general methods and tools for modern data processing. For instance, many labs follow the path of interdisciplinary studies and get their data validated by several methods. Researchers at those labs may not perform all the techniques themselves, but either in collaboration or through outsourcing, they make use of a range of them, because, in the absence of cross validation using different techniques, the chances for acceptance of an article for publication in high profile journals is weakened. Explains how to interpret enormous amounts of data generated using several experimental approaches in simple terms, thus relating biology and physics at the atomic level Presents sample data files and explains the usage of equations and web servers cited in research articles to extract useful information from their own biological data Discusses, in detail, raw data files, data processing strategies, and the web based sources relevant for data processing
| Author | : Roland Kontermann |
| Publisher | : John Wiley & Sons |
| Total Pages | : 373 |
| Release | : 2012-01-31 |
| Genre | : Science |
| ISBN | : 3527644784 |
Download Therapeutic Proteins Book in PDF, ePub and Kindle
For this ready reference, the internationally renowned authority in the field, Roland Kontermann, has assembled a team of outstanding contributors from industry and academia to convey the worldwide knowledge on modifying therapeutic proteins in order to optimize their pharmacological potential. The result is a comprehensive work covering all approaches and aspects of the topic in one handy volume, making this indispensable reading for companies and research institutions working on the development of biopharmaceuticals.
| Author | : Bruce Kirkham |
| Publisher | : OUP Oxford |
| Total Pages | : 176 |
| Release | : 2008-11-27 |
| Genre | : Medical |
| ISBN | : 0191548979 |
Download The Handbook of Biological Therapy Book in PDF, ePub and Kindle
Drugs produced by molecular biological techniques, called the 'biologics', differ from the usual chemical medications. Their optimum use, and the detection and managemenet of adverse events, pose a significant challenge to the clinician. Licences for new biologics continue to be granted for the likes of rituximab, abatacept and certocizumals pegol. Intensive research is also defining new areas in which these drugs will be used in the future, increasing the number of practitioners using biologics. As the use of these drugs increases around the world, so the level of information needed by primary care practitioners and specialist prescribers needs to be expanded The Handbook of Biological Therapy provides the practising clinician with a practica guide to the use of Tumour Necrosis Factor Blocking Therapy (TNF-blockers), and important new class of biologic therapy for rheumatoid arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, psoriasis, and psoriatic arthritis. It is a comprehensive distillation of the authors' clinical experience with these drugs, combined with data from diverse databases offering practical advice on their uses, specific indications, supporting clinical trial data and safety issues, with the aim of making the use of these drugs easier for the busy clinician. All of the authors have been involved from the beginnings of the clinical trial programmes with these drugs and continue to use them in daily practice.
| Author | : Stefan Dübel |
| Publisher | : John Wiley & Sons |
| Total Pages | : 2538 |
| Release | : 2014-12-03 |
| Genre | : Science |
| ISBN | : 3527329374 |
Download Handbook of Therapeutic Antibodies Book in PDF, ePub and Kindle
Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle.
