Описание: Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing.
Автор: Laszlo Endrenyi and Dr. Paul Declerck Название: Biosimilar Drug Product Development ISBN: 1498718795 ISBN-13(EAN): 9781498718790 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.
Pharmaceutical product development is a multidisciplinary activity involving extensive efforts in systematic product development and optimization in compliance with regulatory authorities to ensure the quality, efficacy and safety of resulting products.
Pharmaceutical Product Development equips the pharmaceutical formulation scientist with extensive and up-to-date knowledge of drug product development and covers all steps from the beginning of product conception to the final packaged form that enters the market and lifecycle management thereof.
Applications of core scientific principles for product development are also thoroughly discussed in conjunction with the latest approaches involving design of experiment and quality by design with comprehensive illustrations based on practical case studies of several dosage forms.
The book presents pharmaceutical product development information in an easy-to-read mode with simplified theories, case studies and guidelines for students, academicians and professionals in the pharmaceutical industry. It is an invaluable resource and hands-on guide covering managerial, regulatory and practical aspects of pharmaceutical product lifecycle management.
Автор: Osswald, Tim Название: Understanding Polymer Processing ISBN: 1569906475 ISBN-13(EAN): 9781569906477 Издательство: Mare Nostrum (Eurospan) Рейтинг: Цена: 13793.00 р. Наличие на складе: Нет в наличии.
Описание: This book provides the background needed to understand not only the wide field of polymer processing, but also the emerging technologies associated with the plastics industry in the 21st Century. It combines practical engineering concepts with modeling of realistic polymer processes. Divided into three sections, it provides the reader with a solid knowledge base in polymer materials, polymer processing, and modeling.Understanding Polymer Processing is intended for the person who is entering the plastics manufacturing industry and as a textbook for students taking an introductory course in polymer processing. It also serves as a guide to the practicing engineer when choosing a process, determining important parameters and factors during the early stages of process design, and when optimizing such a process. Practical examples illustrating basic concepts are presented throughout the book.New in the second edition is a chapter on additive manufacturing, together with associated examples, as well as improvements and corrections throughout the book.With the purchase of this book, you also receive a free personal access code to download the eBook.
Автор: Denise Wilson Название: Sensing the Perfect Tomato: An Internet of Sensing Approach ISBN: 036708676X ISBN-13(EAN): 9780367086763 Издательство: Taylor&Francis Рейтинг: Цена: 9492.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book provides a comprehensive overview of the tomato, why it is important, and how it can benefit from numerous sensors, interconnected and placed strategically among tomato crops for greater yield, higher quality, and seamless pre-harvest sensing.
An uncomfortable observation in the Shift Logs and Process Control records of most aluminum smelting plants is that process control failures, large and small, happen every day. Although only a small fraction of these failures give rise to catastrophic events, the difference between a disaster we read about and a failure which, although expensive, has no irreversible consequences, is only chance.
Control for Aluminum Production and Other Processing Industries exemplifies new control thinking fused with an understanding of process variability, and how to diagnose abnormalities and their causes in aluminum production plants. Many real life examples in the book demonstrate the importance of human behavior and a scientific, questioning approach in the control of a technologically complex process. Written from the perspective of production staff and management, the book also gives readers a view into the human aspects of accidents and their analogy with failures in control of production.
Production plants regularly experience more control failures than successes and staff must continuously strive to establish stability and control of their process. Through on-the-job experiences of the authors and their industry colleagues, the control experiences described in this book provide readers with a foundation for building their own robust control rationale and a framework for avoidance of plant control problems.
Автор: Shurong Wang, Zhongyang Luo Название: Pyrolysis of Biomass ISBN: 3110374579 ISBN-13(EAN): 9783110374575 Издательство: Walter de Gruyter Рейтинг: Цена: 18586.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: With the development of societies fossil energy is no longer the only energy resource, and increasing attention had been paid to alternative energy. Biomass is considered to be one of the alternatives due to efficiency and low cost. This book presents biomass pyrolysis behavior for three main components: Cellulose, Hemicellulose and Lignin, and discusses the influence of mineral salts , zeolite catalysts and metal oxide on their pyrolysis.
Автор: Diwekar Название: Batch Processing ISBN: 1138076740 ISBN-13(EAN): 9781138076747 Издательство: Taylor&Francis Рейтинг: Цена: 13014.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Although batch processing has existed for a long time, designing these processes and unit operations has been considered an onerous task that required computational efforts. Design of these processes is made more complex because of the time dependent nature of the process and the allowable flexibility. More often than not, every unit encounters optimal control problems. Therefore, traditional design books have not covered batch processing in detail. Filling this void, Batch Processing: Modeling and Design describes various unit operations in batch and bio-processing as well as design methods for these units.
Topics include:
Batch distillation operating modes and configurations
Batch absorption operations based on the solubility difference
Batch adsorption based on differential affinity of various soluble molecules to solid absorbents
Batch chromatography for measuring a wide variety of thermodynamic, kinetic, and physico-chemical properties
Batch crystallization where a phase is used to find the supersaturation at which point material crystallizes
Batch drying that stresses the phase diagram of water to describe this operation
Batch filtration using a porous medium or screen to separate solids from liquids
Batch centrifugation where centrifugal force is used for separation
Batch processes are widely used in pharmaceutical, food, and specialty chemicals where high value, low volume products are manufactured. Recent developments in bio-based manufacturing also favor batch processes because feed variations can be easily handled in batch processes. Further, the emerging area of nanomaterials manufacturing currently uses batch processes as they are low volume, high energy intensive processes. With examples, case studies, and more than 100 homework problems, this book describes the unit operations in batch and bioprocessing and gives students a thorough grounding in the numerical methods necessary to solve these design problems.
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