Download or read book Biotechnology Operations written by Michael J. Roy and published by CRC Press. This book was released on 2011-06-27 with total page 434 pages. Available in PDF, EPUB and Kindle. Book excerpt: Because of rapid developments in the biotechnology industry—and the wide range of disciplines that contribute to its collective growth—there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
Download or read book Biotechnology Operations written by John M. Centanni and published by CRC Press. This book was released on 2016-09-19 with total page 476 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book describes seven areas in the field of biotechnology operations as practiced by biopharmaceutical firms and nonprofit institutions. Revisions focus upon changes that have occurred in several areas over the past six years, with emphasis on regulatory, biomanufacturing, clinical and technical information, along with processes and guidlines that have added to the discipline. Examples are increased for new technical fields such as cell and tissue engineering. Further, illustrations or figures are added to each chapter to emphasize particular points.
Download or read book Biotechnology Operations written by John M. Centanni and published by CRC Press. This book was released on 2011-03-22 with total page 412 pages. Available in PDF, EPUB and Kindle. Book excerpt: Because of rapid developments in the biotechnology industry—and the wide range of disciplines that contribute to its collective growth—there is a heightened need to more carefully plan and fully integrate biotech development projects. Despite the wealth of operations experience and associated literature available, no single book has yet offered a comprehensive, practical guide to fundamentals. Filling the void, Biotechnology Operations: Principles and Practices reflects this integrative philosophy, serving as a practical guide for students, professionals, or anyone else with interests in the biotech industry. Although many books emphasize specific technical aspects of biotech, this is perhaps the first to integrate essential concepts of product development and scientific and management skills with the seven functional areas of biotechnology: Biomanufacturing Clinical trials Nonclinical studies Project management Quality assurance Quality control Regulatory affairs A practical roadmap to optimizing biotechnology operations, this reference illustrates how to use specific product planning, design, and project management processes to seamlessly merge plans and efforts in the key functional areas. Applying lessons learned throughout the nascent history of biotech, author Michael Roy highlights developmental principles that could bring future products to market more safely and efficiently. Drawing from his experiences working in industry and teaching a graduate course at the University of Wisconsin, this hotly anticipated book clarifies basic methodologies and practices to help reduce risks and resolve problems as future technological discoveries are developed into tangible products.
Download or read book Quality Operations Procedures for Pharmaceutical API and Biotechnology written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2012-06-06 with total page 580 pages. Available in PDF, EPUB and Kindle. Book excerpt: To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-
Download or read book Industrial Biotechnology written by Christoph Wittmann and published by John Wiley & Sons. This book was released on 2017-03-06 with total page 642 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest volume in the Advanced Biotechnology series provides an overview of the main product classes and platform chemicals produced by biotechnological processes today, with applications in the food, healthcare and fine chemical industries. Alongside the production of drugs and flavors as well as amino acids, bio-based monomers and polymers and biofuels, basic insights are also given as to the biotechnological processes yielding such products and how large-scale production may be enabled and improved. Of interest to biotechnologists, bio and chemical engineers, as well as those working in the biotechnological, chemical, and food industries.
Download or read book Biotechnology Operations written by Taylor & Francis Group and published by . This book was released on 2010-09-30 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Biochemical Engineering and Biotechnology written by Ghasem Najafpour and published by Elsevier. This book was released on 2015-02-24 with total page 669 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biochemical Engineering and Biotechnology, 2nd Edition, outlines the principles of biochemical processes and explains their use in the manufacturing of every day products. The author uses a diirect approach that should be very useful for students in following the concepts and practical applications. This book is unique in having many solved problems, case studies, examples and demonstrations of detailed experiments, with simple design equations and required calculations. Covers major concepts of biochemical engineering and biotechnology, including applications in bioprocesses, fermentation technologies, enzymatic processes, and membrane separations, amongst others Accessible to chemical engineering students who need to both learn, and apply, biological knowledge in engineering principals Includes solved problems, examples, and demonstrations of detailed experiments with simple design equations and all required calculations Offers many graphs that present actual experimental data, figures, and tables, along with explanations
Download or read book Code of Massachusetts regulations 2005 written by and published by . This book was released on 2005 with total page 270 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Download or read book Code of Massachusetts regulations 2006 written by and published by . This book was released on 2007 with total page 284 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
Download or read book The Massachusetts Register written by and published by . This book was released on 2005 with total page 351 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book From Breakthrough to Blockbuster written by Donald L. Drakeman and published by Oxford University Press. This book was released on 2022 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Beginning in the 1970s, several scientific breakthroughs promised to transform the creation of new medicines. As investors sought to capitalize on these Nobel Prize-winning discoveries, the biotech industry grew to thousands of small companies around the world. Each sought to emulate what the major pharmaceutical companies had been doing for a century or more, but without the advantages of scale, scope, experience, and massive resources. How could a large collection of small companies, most with fewer than 50 employees, compete in one of the world's most breathtakingly expensive and highly regulated industries? This book shows how biotech companies have met the challenge by creating nearly 40% more of the most important treatments for unmet medical needs. Moreover, they have done so with much lower overall costs. The book focuses on both the companies themselves and the broader biotech ecosystem that supports them. Its portrait of the crucial roles played by academic research, venture capital, contract research organizations, the capital markets, and pharmaceutical companies shows how a supportive environment enabled the entrepreneurial biotech industry to create novel medicines with unprecedented efficiency. In doing so, it also offers insights for any industry seeking to innovate in uncertain and ambiguous conditions. Looking to the future, it concludes that biomedical research will continue to be most effective in the hands of a large group of small companies as long as national healthcare policies allow the rest of the ecosystem to continue to thrive"--
Download or read book Statistics for Biotechnology Process Development written by Todd Coffey and published by CRC Press. This book was released on 2018-05-16 with total page 358 pages. Available in PDF, EPUB and Kindle. Book excerpt: Written specifically for biotechnology scientists, engineers, and quality professionals, this book describes and demonstrates the proper application of statistical methods throughout Chemistry, Manufacturing, and Controls (CMC). Filled with case studies, examples, and easy-to-follow explanations of how to perform statistics in modern software, it is the first book on CMC statistics written primarily for practitioners. While statisticians will also benefit from this book, it is written particularly for industry professionals who don’t have access to a CMC statistician or who want to be more independent in the design and analysis of their experiments. Provides an introduction to the statistical concepts important in the biotechnology industry Focuses on concepts with theoretical details kept to a minimum Includes lots of real examples and case studies to illustrate the methods Uses JMP software for implementation of the methods Offers a text suitable for scientists in the industry with some quantitative training Written and edited by seasoned veterans of the biotechnology industry, this book will prove useful to a wide variety of biotechnology professionals. The book brings together individual chapters that showcase the use of statistics in the most salient areas of CMC.
Download or read book Opportunities in Biotechnology for Future Army Applications written by National Research Council and published by National Academies Press. This book was released on 2001-07-11 with total page 118 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report surveys opportunities for future Army applications in biotechnology, including sensors, electronics and computers, materials, logistics, and medical therapeutics, by matching commercial trends and developments with enduring Army requirements. Several biotechnology areas are identified as important for the Army to exploit, either by direct funding of research or by indirect influence of commercial sources, to achieve significant gains in combat effectiveness before 2025.
Download or read book Quality Operations Procedures for Pharmaceutical API and Biotechnology written by Syed Imtiaz Haider and published by CRC Press. This book was released on 2012-06-06 with total page 586 pages. Available in PDF, EPUB and Kindle. Book excerpt: To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.
Download or read book Basic Laboratory Methods for Biotechnology written by Lisa A. Seidman and published by CRC Press. This book was released on 2021-12-29 with total page 1210 pages. Available in PDF, EPUB and Kindle. Book excerpt: Basic Laboratory Methods for Biotechnology, Third Edition is a versatile textbook that provides students with a solid foundation to pursue employment in the biotech industry and can later serve as a practical reference to ensure success at each stage in their career. The authors focus on basic principles and methods while skillfully including recent innovations and industry trends throughout. Fundamental laboratory skills are emphasized, and boxed content provides step by step laboratory method instructions for ease of reference at any point in the students’ progress. Worked through examples and practice problems and solutions assist student comprehension. Coverage includes safety practices and instructions on using common laboratory instruments. Key Features: Provides a valuable reference for laboratory professionals at all stages of their careers. Focuses on basic principles and methods to provide students with the knowledge needed to begin a career in the Biotechnology industry. Describes fundamental laboratory skills. Includes laboratory scenario-based questions that require students to write or discuss their answers to ensure they have mastered the chapter content. Updates reflect recent innovations and regulatory requirements to ensure students stay up to date. Tables, a detailed glossary, practice problems and solutions, case studies and anecdotes provide students with the tools needed to master the content.
Download or read book Career Opportunities in Biotechnology and Drug Development written by Toby Freedman and published by CSHL Press. This book was released on 2008 with total page 408 pages. Available in PDF, EPUB and Kindle. Book excerpt: An essential guide for students in the life sciences, established researchers, and career counselors, this resource features discussions of job security, future trends, and potential career paths. Even those already working in the industry will find helpful information on how to take advantage of opportunities within their own companies and elsewhere.
Download or read book Code of Massachusetts regulations 2001 written by and published by . This book was released on 2002 with total page 2838 pages. Available in PDF, EPUB and Kindle. Book excerpt: Archival snapshot of entire looseleaf Code of Massachusetts Regulations held by the Social Law Library of Massachusetts as of January 2020.
