Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field
Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature--and it's rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements.
Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future.
Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO--especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions
Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies
Includes many diagrams that clarify the design approach
Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.
Автор: Avis Название: Biotechnology and Biopharmaceutical Manufacturing, Processing, and Preservation ISBN: 1574910167 ISBN-13(EAN): 9781574910162 Издательство: Taylor&Francis Рейтинг: Цена: 357280.00 T Наличие на складе: Есть у поставщика Поставка под заказ. 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: Becky McCuen, Charles Rutter, Gary Gilleskie Название: Biopharmaceutical Manufacturing: Principles, Processes, and Practices ISBN: 3110616874 ISBN-13(EAN): 9783110616873 Издательство: Walter de Gruyter Рейтинг: Цена: 100350.00 T Наличие на складе: Нет в наличии. Описание:
Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:
Автор: Shukla, Abhinav A. Название: Process Scale Bioseparations for the Biopharmaceutical Industry ISBN: 0367577844 ISBN-13(EAN): 9780367577841 Издательство: Taylor&Francis Рейтинг: Цена: 48990.00 T 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: 48990.00 T 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
Название: A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry ISBN: 0367875721 ISBN-13(EAN): 9780367875725 Издательство: Taylor&Francis Рейтинг: Цена: 57150.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effe
Автор: Gutka Hiten J., Yang Harry, Kakar Shefali Название: Biosimilars: Regulatory, Clinical, and Biopharmaceutical Development ISBN: 3319996797 ISBN-13(EAN): 9783319996790 Издательство: Springer Рейтинг: Цена: 158380.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: This book provides a comprehensive overview of the biosimilar regulatory framework, the development process and clinical aspects for development of biosimilars. The development path of a biosimilar is just as unique as a development path of a new drug, tailored by the mechanism of action, the quality of the molecule, published information on the reference product, the current competitive environment, the target market and regulatory guidance, and most importantly, the emerging totality of evidence for the proposed biosimilar during development. For the ease of readers, the book comprises of six sections as follows: Section I: Business, Health Economics and Intellectual Property Landscape for Biosimilars Section II: Regulatory Aspects of Development and Approval for Biosimilars Section III: Biopharmaceutical Development and Manufacturing of Biosimilars Section IV: Analytical Similarity Considerations for Biosimilars Section V: Clinical aspects of Biosimilar Development Section VI: Biosimilars- Global Development and Clinical Experience Chapters have been written by one or more experts from academia, industry or regulatory agencies who have been involved with one or more aspects of biosimilar product development. The authors and editors have an expertise in commercialization and pricing of biosimilars, intellectual property considerations for biosimilars, chemistry manufacturing controls (CMC) and analytical development for biosimilars, regulatory and clinical aspects of biosimilar development. Besides the industry practitioners, the book includes several contributions from regulators across the globe.
Автор: Niall Barron Название: MicroRNAs as Tools in Biopharmaceutical Production ISBN: 9400795262 ISBN-13(EAN): 9789400795266 Издательство: Springer Рейтинг: Цена: 104480.00 T 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.
Автор: Koulov, Atanas Название: Surfactants in Biopharmaceutical Development ISBN: 0128125039 ISBN-13(EAN): 9780128125038 Издательство: Elsevier Science Рейтинг: Цена: 153830.00 T 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
Автор: Jameel Feroz, Skoug John W., Nesbitt Robert R. Название: Development of Biopharmaceutical Drug-Device Products ISBN: 3030314146 ISBN-13(EAN): 9783030314149 Издательство: Springer Рейтинг: Цена: 214280.00 T Наличие на складе: Есть у поставщика Поставка под заказ. Описание: Foreword Juergen M. Zeidler, PhD and Ramakrishna Venugopalan, PhD (AbbVie) 0Part 1: Drug Product Development1 Monoclonal Antibodies: Structure, Physicochemical Stability and Protein Engineering Brittney Mills, Ehab Moussa and Feroz Jameel (AbbVie) 12 Challenges and Considerations in the Design of Antibody Drug Conjugates Feroz Jameel, Brittney Mills, Ehab Moussa and Vikram Sisodiya, Anthony Haight and Tony Cano (AbbVie) 218 Enabling Drug-Device Combination Products: Device-ability in Protein Therapeutics Bernardo Perez-Ramirez, PhD, Jon Kingsbury, and Jifeng Zhang (Sanofi-Genzyme) 33 Production Strategies and Challenges with IgG-based Bispecific Antibody Formats Chen Gu and Diego Ellerman (Genentech) 44 Lessons Learned in Understanding Dual-variable Domain Ig (DVD-Ig) Structural Complexity to Select DVD-Ig Lead and Therapeutic Candidates W. Blaine Stine, Dana Filoti and Tariq Ghayur (AbbVie) 56 High-Throughput Conformational and Colloidal Stability Screening of Biologic Molecules Peter M. Ihnat, Jun Zhang, Jianwen Xu and Kan Wu (AbbVie) 68 An Empirical Phase Diagram/High-Throughput Screening Approach to the Characterization and Formulation of Biopharmaceuticals Russell Middaugh, Yangje Wei, Sangeet Joshi, Akhilesh Bhambhani, Yuhong Zeng, Nicholas Larson, Gang Hu, Eric Deeds (University of Kansas) 79 Biophysical Characterization and the Development of Therapeutic Proteins Russell Middaugh, Yangje Wei, Nicholas Larson, Gang Hu, Prashant Kumar (University of Kansas) 85 Leveraging the Multi-Attribute Method (MAM) to Improve Biotherapeutic Development Richard Rogers, PhD (Just Biotherapeutics) 97 Analytical Methods for Antibody Drug Conjugate Characterization Stephanie Fischmann, Julie Heflin, Joseph Eschweiler, Beijing Huang, Maike Eisenkolb, Stephanie Katzenbach and Gregory Webster (AbbVie) 10 Part 1: Drug Product Development, (continued): Chapter: Title Authors New #15 Particles in Liquid Drug Products: Causes, Characterization and Strategy Anacelia Rнos Quiroz, Miguel Saggu, Jan Olaf Stracke & Jamie Moore (Roche & Genentech) 1110 Strategies in the Development of Formulations for Antibody based Therapeutics Feroz Jameel, Ehab Moussa, Brittney Mills and Peter Ihnat (AbbVie) 1211 Formulation, Drug Product Process and Delivery Considerations for Bi-specific Antibody-Based Molecules Krishnan Sampathkumar (Macrogenics) Status TBD 1312 Formulation Development for Biologics Utilizing Lab Automation and In Vivo Performance Models Michael Siedler, Sabine Eichling, Martin Huelsmeyer, and Jonas Angstenberger (AbbVie) 1413 Practical considerations in high concentration formulation development for monoclonal antibody drug products Dingjiang (Dean) Liu, Quingyan Hu, Bowen Jiang, Xiaolin (Charlie) Tang, Thomas Daly, Mohammed Shameem (Regeneron) 1514 Drug Product Formulation Robustness Criteria for a MAb in a Pre-filled Syringe Karen Rutherford, Greg Downing and Alvattam Sreedhara (Genentech) 1616 Development of Robust Lyophilization Process for Therapeutic Proteins: A case Study Ehab Moussa, Tong Zhu and Feroz Jameel (AbbVie) 1719 Scale-Down Models for Robust Biologics Drug Product Process Development Smeet Deshmukh, Maria O. Ogunyankin (Merck) 1826 Design of Clinical in use Studies Supriya Gupta, Amr Alaarg, Zhen Wu, Xiaofeng Lu, Vivek Garripelli, Hanmin Dong, Stephanie Sawilla, Bhargav Patel, and Rudolf Schroeder, (AbbVie) 1920 Design of a Bulk Freeze-Thaw Process for Biologicals Feroz Jameel, Tong Zhu, Ehab Moussa and Brittney Mills (AbbVie) 2021 Freeze-Thaw Process Analysis and Mechanistic Modeling: Simplified Lumped Capacitance Analysis for Small Fill Volumes Alina A. Alexeenko (Purdue Univ.), Laura Mozdzen, Sherwin Shang, Michelle Long, Grace Kim
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.
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