Development of Biopharmaceutical Drug-Device Products, Jameel Feroz, Skoug John W., Nesbitt Robert R.
Автор: Spada, Stefania , Walsh, Gary Название: Directory of Approved Biopharmaceutical Products ISBN: 0367393964 ISBN-13(EAN): 9780367393960 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Biopharmaceuticals, the term for genetically engineered therapeutic proteins, monoclonal antibodies, and nucleic acid-based products, have become an increasing part of the pharmaceutical armament. While this category of drugs accounts for approximately 25% of all new drugs coming to market, very few references exist that review these commercially available products. Until now, accessing data on the list of currently approved biopharmaceuticals has been laborious and patchy.
Directory of Approved Biopharmaceutical Products brings together key information on various aspects of these compounds, presenting a brief summary of each biopharmaceutical currently approved for medical use. Each summary includes the scientific and trade name, year and regions approved, approved indications, manufacturer, marketing right, method of manufacture, scientific overview, and therapeutic properties. Based on information gathered from regulatory agencies and pharmaceutical manufacturers, the book presents the most comprehensive data currently available in a single, convenient volume. This comprehensive and consistent approach will save professionals in the pharmaceutical industry hours spent trawling the literature - and provides a singular resource for future reference.
Автор: Feroz Jameel; Susan Hershenson; Mansoor A. Khan; S Название: Quality by Design for Biopharmaceutical Drug Product Development ISBN: 1493923153 ISBN-13(EAN): 9781493923151 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development.
Описание: Describes practices applicable to the large-scale processing of biotechnological products. Beginning with processing and bulk storage preservation techniques, this book provides strategies for improving efficiency of process campaigns of multiple products and manufacturing facilities for such processing techniques.
Автор: Lanju Zhang; Ding-Geng (Din) Chen; Hongmei Jiang; Название: Contemporary Biostatistics with Biopharmaceutical Applications ISBN: 3030153096 ISBN-13(EAN): 9783030153090 Издательство: Springer Рейтинг: Цена: 13974.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This edited volume presents current research in biostatistics with emphasis on biopharmaceutical applications. Featuring contributions presented at the 2017 ICSA Applied Statistics Symposium held in Chicago, IL on June 25 to 28, 2017, this book explores timely topics that have a high potential impact on statistical methodology and future research in biostatistics and biopharmaceuticals. The theme of this conference was Statistics for a New Generation: Challenges and Opportunities, in recognition of the advent of a new generation of statisticians. The conference attracted statisticians working in academia, government, and industry; domestic and international statisticians. From the conference, the editors selected 28 high-quality presentations and invited the speakers to prepare full chapters for this book. These contributions are divided into four parts: Part I Biostatistical Methodology, Part II Statistical Genetics and Bioinformatics, Part III Regulatory Statistics, and Part IV Biopharmaceutical Research and Applications.Featuring contributions on topics such as statistics in genetics, bioinformatics, biostatistical methodology, and statistical computing, this book is beneficial to researchers, academics, practitioners and policy makers in biostatistics and biopharmaceuticals.
Автор: Koulov, Atanas Название: Surfactants in Biopharmaceutical Development ISBN: 0128125039 ISBN-13(EAN): 9780128125038 Издательство: Elsevier Science Рейтинг: Цена: 22738.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Surfactants in Biopharmaceutical Development addresses the progress, challenges and opportunities for surfactant research specific to pharmaceutical development, providing a broad range of important surfactant-related topics as they relate directly to the biopharmaceutical process. Chapters address fundamental topics, like mechanisms of protein stabilization by surfactants, the latest, state-of-the-art technology and methods to illustrate the practical application to biopharmaceutical development, forward-looking chapters on control strategies and novel surfactants, with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators.
It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients by the industry and by regulators.
Describes the current state of research on surfactants, drawing upon contributions from international experts across industry and academia
Addresses the opportunities and challenges associated with surfactants in drug development and delivery
Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics
Summarizes the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume
This up-to-the-minute reference delineates-in a systematic fashion-the appropriate, sequential steps for the formulation of safe, effective, stable, and marketable liquid parenteral biopharmaceutical products-covering fundamentals and essential pathways for each phase as well as its purpose, function, and relation to other stages in the product development process. Written by experts currently involved in state-of-the-art advances in the pharmaceutical drug industry, Development of Biopharmaceutical Parenteral Dosage Forms
details biopharmaceuticals that are licensed or undergoing clinical development, including genetically engineered cell and engineered vectors in the fermentation process
describes purification and characterization techniques for rDNA therapeutics, discussing several types of unit operations for isolation, purification, and characterization
considers preformulation and formulation requirements, such as physicochemical properties, drug delivery, stability studies programs, deactivation/denaturation routes, selection of compatible excipients, and regulatory compliance
elucidates basics of analytical techniques, methods development, separation methods using chromatographic and electrophoretic techniques, and bioactivity methods covering bioassays and immunoassays for quantifying the stability of biological activity
shows how to select the appropriate filter for maximizing compatibility and minimizing adsorption and inactivation, examining topics from basic filtration theories to future trends
reviews the selection process for compatible elastomeric closures, analyzing physical, chemical, toxicological properties, protein adsorption on elastomeric surfaces, strategies to reduce/eliminate adsorption, and specialized containers for biotechnological applications
and more! Furnished with helpful references, tables, and drawings, this practical guide is indispensable
Автор: Niall Barron Название: MicroRNAs as Tools in Biopharmaceutical Production ISBN: 9400795262 ISBN-13(EAN): 9789400795266 Издательство: Springer Рейтинг: Цена: 15672.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book explores the uses of MicroRNAs in bioprocessing, especially in production of complex proteins in mammalian cells. Covers genomic organization, biogenesis and mode of action; miRNAs as biomarkers; manipulation of expression in cultured cells and more.
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