Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-01-24 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technology Transfer written by Ajay Babu Pazhayattil and published by Springer Nature. This book was released on 2023-06-16 with total page 158 pages. Available in PDF, EPUB and Kindle. Book excerpt: Currently, there are no textbooks on drug product manufacturing technology transfer that incorporate the latest regulatory expectations. Recent guidance from regulatory bodies such as the US FDA, EMEA, WHO, and PIC/S has adopted the ICH Lifecycle approach harmonizing concepts across regulatory guidance. This allows organizations to align their technology transfer activities for all regulated markets. However, there is a need for consensus and direction in approaching technology transfer, particularly in understanding how to manage the scale-up effects to ensure regulatory compliance. This textbook offers technology transfer solutions and guidance to the pharmaceutical industry. The chapters provide a systematic understanding of applying the technology transfer concepts in pharmaceutical manufacturing, promoting standardization within the industry. Since Stage 1b is not specified in detail within the regulations, pharmaceutical organizations are left to determine the requirements of the stage. The need to justify the methodologies and utilization of sound science makes it more demanding. The textbook’s authors provide innovative solutions for technology transfer challenges, making it a comprehensive reference document. The approaches can be applied to both small-molecule and large-molecule drug product manufacturing segments, addressing the unmet needs of the industry.
Download or read book Pharmaceutical Preformulation and Formulation written by Mark Gibson and published by CRC Press. This book was released on 2016-04-19 with total page 562 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Preformulation and Formulation: A Practical Guide from Candidate Drug Selection to Commercial Dosage Form reflects the mounting pressure on pharmaceutical companies to accelerate the new drug development and launch process, as well as the shift from developing small molecules to the growth of biopharmaceuticals. The book meets the ne
Download or read book Technology Transfer in the Pharmaceutical Industry written by Lawrence H. Wortzel and published by . This book was released on 1971 with total page 53 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technology Transfer Systems in the United States and Germany written by Fraunhofer Institute for Systems and Innovation Research and published by National Academies Press. This book was released on 1997-10-10 with total page 444 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book explores major similarities and differences in the structure, conduct, and performance of the national technology transfer systems of Germany and the United States. It maps the technology transfer landscape in each country in detail, uses case studies to examine the dynamics of technology transfer in four major technology areas, and identifies areas and opportunities for further mutual learning between the two national systems.
Download or read book Technology Transfer in the Pharmaceutical Industry written by and published by . This book was released on 1972 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Facets of Technology Transfer written by Manthan D. Janodia and published by . This book was released on 2008 with total page 6 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technology Transfer written by and published by . This book was released on 1988 with total page 64 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Transfer of Technology for Successful Integration Into the Global Economy written by United Nations and published by New York and Geneva : United Nations. This book was released on 2003 with total page 230 pages. Available in PDF, EPUB and Kindle. Book excerpt: This publication contains three case studies which seek to disseminate information on best practices for promoting transfer of technology in developing countries, in order to help establish new industries which can successfully compete in the global economy. These studies were carried out under the UNCTAD/UNDP Programme on Globalization, Liberalization and Sustainable Human Development, and deal with aircraft manufacturing in Brazil, the pharmaceuticals sector in India and the automobile industry in South Africa.
Download or read book Technology Transfer in Biotechnology written by Prabuddha Ganguli and published by John Wiley & Sons. This book was released on 2009-04-22 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt: Here, the world's top experts impart their knowledge and experience, many in print for the first time. By considering developing country markets, this book is the first truly global guide to technology transfer, helping companies all around the world to avoid costly mistakes in product development and to recover investments quickly. Individual sections treat trade-related aspects of intellectual property rights, technology transfer in health and healthcare as well as in agriculture and the environment.
Download or read book Transfer of Technology for Pharmaceutical Chemicals written by Ayhan Çilingiroğlu and published by Organisation for Economic Co-operation and Development ; [Washington : sold by OECD Publications Center]. This book was released on 1975 with total page 134 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Effective Technology Transfer In Biotechnology Best Practice Case Studies In Europe written by Oliver Uecke and published by World Scientific. This book was released on 2015-01-06 with total page 291 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biotechnology is referred to as one of the key enabling technologies of the 21st century. It has the potential to offer solutions for a number of health and resource-based problems the world is facing, such as unmet medical needs and fossil fuel dependency. Considerable effort and investment has been expended in recent years to try and improve the outcomes of technology transfer in order to fulfill this potential.This book presents seventeen best-practice case studies on the topic of effective technology transfer in biotechnology. The selected case studies focus on technology transfer offices, funding models, incubators, education and clusters. Each presents an overview of an initiative that was deployed in Europe with the aim of supporting and stimulating the transfer of biotechnology discoveries and technologies from research laboratories to society. Readers are provided with a critical assessment of each initiative and policy makers, entrepreneurs, cluster managers and research institute managers will find inspiring lessons they can draw on when developing and implementing similar initiatives elsewhere.These cases are the product of research undertaken as part of the ETTBio (Effective Technology Transfer in Biotechnology) project, co-financed by the European Union (ERDF — European Regional Development Fund) and made possible by the INTERREG IVC Programme. ETTBio commenced in January 2012 and concluded in December 2014.
Download or read book Continuous Manufacturing for the Modernization of Pharmaceutical Production written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-04-05 with total page 69 pages. Available in PDF, EPUB and Kindle. Book excerpt: On July 30-31, 2018, the National Academies of Sciences, Engineering, and Medicine held a workshop titled Continuous Manufacturing for the Modernization of Pharmaceutical Production. This workshop discussed the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics such as enzymes, monoclonal antibodies, and vaccines. The participants also discussed specific challenges for integration across the manufacturing system, including upstream and downstream processes, analytical techniques, and drug product development. The workshop addressed these challenges broadly across the biologics domain but focused particularly on drug categories of greatest FDA and industrial interest such as monoclonal antibodies and vaccines. This publication summarizes the presentations and discussions from the workshop.
Download or read book Closing the Loop written by Paul F. Witinski and published by . This book was released on 2010 with total page 57 pages. Available in PDF, EPUB and Kindle. Book excerpt: Technology transfer is a significant challenge within the highly regulated pharmaceutical industry. While much focus is put on the logistics and strategy of the process, less attention has been paid to how to change the soft, non-technical aspects of technology transfer program management, even though these cultural, communication, and perception aspects may be just as important for project success. The goal of this study was to provide recommendations on how to change these factors to improve the likelihood of project success for pharmaceutical technology transfers. The work was conducted at Novartis Vaccines and Diagnostics, a large pharmaceutical manufacturer, so the cases studied here were all transfers of complex vaccine processes and products. While the results were intended to be generalizable to intra-firm technology transfers within pharmaceutical companies, some types of possible transfers were not included in this study. The focus of this thesis was on examining different aspects of how companies manage technology transfer projects and correlating these with how successful those projects have been to look for statistically significant relationships. The approach was two-fold: high level surveys and interviews to qualitatively identify commonly seen issues and subsequent effects, followed by a more detailed quantitative survey of individual projects. The results of detailed surveys of individual project found no significant correlations between the studied project management factors and success. Since similar quantitative studies have succeeded in the past, the differences between this study and these previous studies were explored to determine why this particular study did not produce the desired results. Based on the qualitative interview and survey results, the following recommendations were made on how pharmaceutical companies can improve the likelihood of successful technology transfers: 1) increase face-to-face interaction between team members, 2) better align priorities between different functions, sites, and projects, 3) coordinate with corporate senior management to foster collaboration between Research and Technology Development, and 4) fully engage all necessary functions at the start of each project.
Download or read book Technology Transfer written by Mark Gibson and published by . This book was released on 2005 with total page 232 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Technology Transfer Dynamics written by Mona Mourshed and published by . This book was released on 1999 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Promoting Access to Medical Technologies and Innovation Intersections between Public Health Intellectual Property and Trade written by World Intellectual Property Organization and published by WIPO. This book was released on 2013 with total page 259 pages. Available in PDF, EPUB and Kindle. Book excerpt: This study has emerged from an ongoing program of trilateral cooperation between WHO, WTO and WIPO. It responds to an increasing demand, particularly in developing countries, for strengthened capacity for informed policy-making in areas of intersection between health, trade and IP, focusing on access to and innovation of medicines and other medical technologies.
