Автор: Parag Kolhe; Mrinal Shah; Nitin Rathore Название: Sterile Product Development ISBN: 1461479770 ISBN-13(EAN): 9781461479772 Издательство: Springer Рейтинг: Цена: 30745.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This book addresses key concepts and applications in sterile product development. Throughout, it illustrates key concepts relevant to the successful development of sterile products with the help of case studies.
Since sterile filtration and purification steps are becoming more prevalent and critical within medicinal drug manufacturing, the third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of bioprocessing including the current methods, processes, technologies and equipment. It also covers industry standards and regulatory requirements for the pharmaceutical and biopharmaceutical industries. The book is an essential, comprehensive source for all involved in filtration and purification practices, training and compliance. It describes such technologies as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration.
Features:
Addresses recent biotechnology-related processes and advanced technologies such as viral retentive filters, membrane chromatography, downstream processing, cell harvesting, and sterile filtration of medium, buffer and end product
Presents detailed updates on the latest FDA and EMA regulatory requirements involving filtration and purification practices, as well as discussions on best practises in filter integrity testing
Describes current industry quality standards and validation requirements and provides guidance for compliance, not just from an end-user perspective, but also supplier requirement
It discusses the advantages of single-use process technologies and the qualification needs
Sterilizing grade filtration qualification and process validation is presented in detail to gain the understanding of the regulatory needs
The book has been compilated by highly experienced contributors in the field of pharmaceutical and biopharmaceutical processing. Each specific topic has been thoroughly examined by a subject matter expert.
Автор: Maik W. Jornitz; O.W. Reif; M.W. Jornitz; R.V. Lev Название: Sterile Filtration ISBN: 354028625X ISBN-13(EAN): 9783540286257 Издательство: Springer Рейтинг: Цена: 34937.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: 1 R. Levy: Types of Filtration.- 2 T. Meltzer: Modus of Filtration.- 3 O.W. Reif: Microfiltration Membranes: Characteristics and Manufacturing.- 4 M. Jornitz: Filter Constructions and Design.- 5 R. Madsen: Filter Validation.- 6 M. Jornitz: Integrity Testing.-
Автор: Odum, Jeffrey N. Название: Sterile Product Facility Design and Project Management ISBN: 0367394405 ISBN-13(EAN): 9780367394400 Издательство: Taylor&Francis Рейтинг: Цена: 9798.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:
Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices.
Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.
Автор: Akers, Michael J. Название: Sterile Drug Products ISBN: 0849339936 ISBN-13(EAN): 9780849339936 Издательство: Taylor&Francis Рейтинг: Цена: 27562.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Автор: Edited By Maik W. Jornitz Название: Filtration and Purification in the Biopharmaceutical Industry ISBN: 1032338288 ISBN-13(EAN): 9781032338286 Издательство: Taylor&Francis Рейтинг: Цена: 7348.00 р. Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: The third edition of Filtration and Purification in the Biopharmaceutical Industry greatly expands its focus with extensive new material on the critical role of purification and advances in filtration science and technology. It provides state-of-the-science information on all aspects of this field including the current methods, pro
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