A Lifecycle Approach To Knowledge Excellence In The Biopharmaceutical Industry
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A Lifecycle Approach To Knowledge Excellence In The Biopharmaceutical Industry
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Author : Nuala Calnan
language : en
Publisher: CRC Press
Release Date : 2017-06-26
A Lifecycle Approach To Knowledge Excellence In The Biopharmaceutical Industry written by Nuala Calnan and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017-06-26 with Medical categories.
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 effective use of an organisation’s knowledge assets can provide a path towards business excellence.
Multivariate Analysis In The Pharmaceutical Industry
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Author : Ana Patricia Ferreira
language : en
Publisher: Academic Press
Release Date : 2018-04-24
Multivariate Analysis In The Pharmaceutical Industry written by Ana Patricia Ferreira and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-04-24 with Medical categories.
Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. - Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges - Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications - Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come
Process Validation In Manufacturing Of Biopharmaceuticals
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Author : Anurag Singh Rathore
language : en
Publisher: CRC Press
Release Date : 2023-12-18
Process Validation In Manufacturing Of Biopharmaceuticals written by Anurag Singh Rathore and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-12-18 with Medical categories.
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.
Eckm 2023 24th European Conference On Knowledge Management Vol 2
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Author : Alvaro Rosa
language : en
Publisher: Academic Conferences and publishing limited
Release Date : 2023-09-07
Eckm 2023 24th European Conference On Knowledge Management Vol 2 written by Alvaro Rosa and has been published by Academic Conferences and publishing limited this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-09-07 with Business & Economics categories.
These proceedings represent the work of contributors to the 24th European Conference on Knowledge Management (ECKM 2023), hosted by Iscte – Instituto Universitário de Lisboa, Portugal on 7-8 September 2023. The Conference Chair is Prof Florinda Matos, and the Programme Chair is Prof Álvaro Rosa, both from Iscte Business School, Iscte – Instituto Universitário de Lisboa, Portugal. ECKM is now a well-established event on the academic research calendar and now in its 24th year the key aim remains the opportunity for participants to share ideas and meet the people who hold them. The scope of papers will ensure an interesting two days. The subjects covered illustrate the wide range of topics that fall into this important and ever-growing area of research. The opening keynote presentation is given by Professor Leif Edvinsson, on the topic of Intellectual Capital as a Missed Value. The second day of the conference will open with an address by Professor Noboru Konno from Tama Graduate School and Keio University, Japan who will talk about Society 5.0, Knowledge and Conceptual Capability, and Professor Jay Liebowitz, who will talk about Digital Transformation for the University of the Future. With an initial submission of 350 abstracts, after the double blind, peer review process there are 184 Academic research papers, 11 PhD research papers, 1 Masters Research paper, 4 Non-Academic papers and 11 work-in-progress papers published in these Conference Proceedings. These papers represent research from Australia, Austria, Brazil, Bulgaria, Canada, Chile, China, Colombia, Cyprus, Czech Republic, Denmark, Finland, France, Germany, Greece, Hungary, India, Iran, Iraq, Ireland, Israel, Italy, Japan, Jordan, Kazakhstan, Kuwait, Latvia, Lithuania, Malaysia, México, Morocco, Netherlands, Norway, Palestine, Peru, Philippines, Poland, Portugal, Romania, South Africa, Spain, Sweden, Switzerland, Taiwan, Thailand, Tunisia, UK, United Arab Emirates and the USA.
The Palgrave Handbook Of Knowledge Management
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Author : Jawad Syed
language : en
Publisher: Springer
Release Date : 2018-05-11
The Palgrave Handbook Of Knowledge Management written by Jawad Syed and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-05-11 with Business & Economics categories.
This international Handbook provides a comprehensive overview of key topics, debates and issues within the now well-established field of Knowledge Management (KM). With contributions from a range of highly-skilled authors, diverse and multi-disciplinary approaches towards KM are explored in this fantastic new reference work. Topics covered include performance, ethics, sustainability and cross-cultural management, making this an equally important read to academics and practitioners working in areas such as technology, education and engineering. By analysing how the field of KM has developed over the years, as well as presenting new methods to be implemented in the workplace, this Handbook outlines a research agenda for the future of organisational learning and innovation.
Biopharmaceuticals
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Author : Basanta Behera
language : en
Publisher: CRC Press
Release Date : 2020-12-07
Biopharmaceuticals written by Basanta Behera and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-12-07 with Medical categories.
Biopharmaceuticals: Challenges and Opportunities This book highlights how the traditional microbial process technology has been upgraded for the production of biologic drugs how manufacturing processes have evolved to meet the global market demand with quality products under the guidelines of internally recognized regulatory bodies. It also carries information on how, armed with a deeper understanding of life-threatening diseases, biopharmaceutical companies and the life sciences industry have developed formal and informal partnerships with researchers in institutes, universities, and other R&D organizations to fulfil timely, quality production with perfect safety and security. One of the most interesting aspects of this book is the conceptual development of personalized medicine (or precision medicine) to provide the right treatment to the right patient, at the right dose at an earlier stage of development, for genetic diseases. Besides this, it also highlights the most challenging aspects of modern biopharmaceutical science, focusing on the hot topics such as design and development of biologic drugs; the use of diversified groups of host cells belonging to animals, plants, microbes, insects, and mammals; stem cell therapy and gene therapy; supply chain management of biopharmaceuticals; and the future scope of biopharmaceutical industry development. This book is the latest resource for a wide circle of scientists, students, and researchers involved in understanding and implementing the knowledge of biopharmaceuticals to develop life-saving biologic drugs and to bring awareness to the development of personalized treatment that can potentially offer patients a faster diagnosis, fewer side effects, and better outcomes. Features: Explains how the traditional cell culture methodology has been changed to a fully continuous or partially continuous process Explains how to design and fabricate living organs of body by 3D bioprinting technology Focuses on how a biopharmaceutical company deals with various problems of regulatory bodies and develops innovative biologic drugs Narrates in detail the updated information on stem cell therapy and gene therapy Explains the development strategies and clinical significance of biosimilars and biobetters Highlights the supply chain management of biopharmaceuticals
Biopharmaceutical Processing
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Author : Gunter Jagschies
language : en
Publisher: Elsevier
Release Date : 2018-01-18
Biopharmaceutical Processing written by Gunter Jagschies and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-18 with Technology & Engineering categories.
Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the product in the biotherapeutics arena, and this book covers every stage including all technologies related to downstream purification and upstream processing fields. Economic considerations are included throughout, with recommendations for lowering costs and improving efficiencies. Designed for quick reference and easy accessibility of facts, calculations and guidelines, this book is an essential tool for industrial scientists and managers in the biopharmaceutical industry. - Offers a comprehensive, go-to reference for daily work decisions - Covers both upstream and downstream processes - Includes case studies that emphasize financial outcomes - Presents summaries, decision grids, graphs and overviews for quick reference
Leading Pharmaceutical Operational Excellence
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Author : Thomas Friedli
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-11-26
Leading Pharmaceutical Operational Excellence written by Thomas Friedli and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-11-26 with Business & Economics categories.
Achieving operational excellence is a challenge for the pharmaceutical industry, with many companies setting successful examples time and again. This book presents such leading practices for managing operational excellence throughout the pharmaceutical industry. Based on the St.Gallen OPEX Model the authors describe the current status of OPEX and the future challenges that have to be dealt with. The ample theoretical background is complemented hand-in-hand by case studies contributed by authors from leading pharmaceutical companies.
Business Development For The Biotechnology And Pharmaceutical Industry
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Author : Martin Austin
language : en
Publisher: Gower Publishing, Ltd.
Release Date : 2008
Business Development For The Biotechnology And Pharmaceutical Industry written by Martin Austin and has been published by Gower Publishing, Ltd. this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008 with Business & Economics categories.
In recognition of the sparse information available to practitioners in the field of business development, Martin Austin has drawn on his 30 years of experience in the pharmaceutical industry to provide this highly practical guide spanning the complete process. Based on the well-established training programme he has developed and delivers to pharmaceutical executives from across the world, this book will help expand your knowledge in this immense area.
Ispe Good Practice Guide
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Author : Ispe
language : en
Publisher:
Release Date : 2019-01-24
Ispe Good Practice Guide written by Ispe and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-01-24 with categories.