Biotechnology Operations

Author: John M. Centanni
Publisher: CRC Press
ISBN: 1498758851
Format: PDF
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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.

Biotechnology Operations

Author: Michael J. Roy
Publisher: CRC Press
ISBN: 1439830282
Format: PDF
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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.

Quality Operations Procedures for Pharmaceutical API and Biotechnology

Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 143988692X
Format: PDF, Mobi
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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.

Molecular Biotechnology

Author: Channarayappa
Publisher: CRC Press
ISBN:
Format: PDF, Kindle
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Providing a strong base in this emerging and highly promising field, Molecular Biotechnology: Principles and Practice strikes a balance between two important aspects of the science - the theory of molecular biology and the experimental approach to the study of biological processes. The main feature of this book is that it covers a wide range of molecular techniques in biotechnology and is designed to be a student- and teacher-friendly textbook. Each technique is described conceptually, followed by a detailed experimental account of the steps involved. The book can also serve as reference to the interested reader who is venturing into the field of biotechnology for the first time.

BIOSPERATIONS

Author: B. SIVASANKAR
Publisher: PHI Learning Pvt. Ltd.
ISBN: 8120326490
Format: PDF, Mobi
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This systematically organized and well-balanced book compresses within the covers of a single volume the theoretical principles and techniques involved in bio-separations, also called downstream processing. These techniques are derived from a range of subjects, for example, physical chemistry, analytical chemistry, bio-chemistry, biological science and chemical engineering. Organized in its 15 chapters, the text covers in the first few chapters topics related to chemical engineering unit operations such as filtration, centrifugation, adsorption, extraction and membrane separation as applied to bioseparations. The use of chromatography as practiced at laboratory as well as industrial scale operation and related techniques such as gel filtration, affinity and pseudoaffinity chromatography, ion-exchange chromatography, electrophoresis and related methods have been discussed. The important applications of these techniques have also been highlighted.

The Regulatory Challenge of Biotechnology

Author: Han Somsen
Publisher: Edward Elgar Publishing
ISBN: 1847204414
Format: PDF
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. . . a compilation of 12 invaluable contributions on this issue by internationally known experts in their respective fields. . . a valuable resource for academic professionals, policy makers and legislators, advocacy groups and scholars in legal and development studies. It is a storehouse of learning and practical knowledge for anyone interested in environmental policy, biosafety issues, biotechnology processes and associated regulatory constraints. Marcelin Tonye Mahop, Review of European Community and International Environmental Law For bioethicists, legal scholars and regulators struggling with what controls to place on biotechnology, this is required reading. John Avellanet, Journal of Commercial Biotechnology Biotechnology has prompted a revolution in science and society in the truest sense of the word. For what superficially appears to be a revolution in biotechnology, in effect touches upon the fundamentals of life and the way in which humans relate to it. This book will make a significant contribution to the debate surrounding the effective regulation of biotechnology. The contributing authors assess how regulatory regimes can accommodate the many different and often conflicting issues to which biotechnology is giving rise to (including a very tainted public image). The book s ultimate aim is to explore ways of designing a regulatory regime that takes heed of these different demands whilst, at the same time, answering to the imperatives of effectiveness and efficiency. The book synthesizes three fields of legal analysis; the first focuses on the risk-dominated regulation of GM food and bio-agriculture; the second involves human genetics as a field dominated by considerations of ethics. Finally, patent law has been chosen as an area captured by notions of property. With its holistic approach, The Regulatory Challenge of Biotechnology will be of great interest to academics, policymakers and regulators as well as biotechnology and law students.

Pharmaceutical Biotechnology

Author: Gary Walsh
Publisher: John Wiley & Sons
ISBN: 111868575X
Format: PDF, ePub, Mobi
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Pharmaceutical Biotechnology offers students taking Pharmacyand related Medical and Pharmaceutical courses a comprehensiveintroduction to the fast-moving area of biopharmaceuticals. With aparticular focus on the subject taken from a pharmaceuticalperspective, initial chapters offer a broad introduction to proteinscience and recombinant DNA technology- key areas that underpin thewhole subject. Subsequent chapters focus upon the development,production and analysis of these substances. Finally the book moveson to explore the science, biotechnology and medical applicationsof specific biotech products categories. These include not onlyprotein-based substances but also nucleic acid and cell-basedproducts. introduces essential principles underlining modernbiotechnology- recombinant DNA technology and protein science an invaluable introduction to this fast-moving subject aimedspecifically at pharmacy and medical students includes specific ‘product category chapters’focusing on the pharmaceutical, medical and therapeutic propertiesof numerous biopharmaceutical products. entire chapter devoted to the principles of genetic engineeringand how these drugs are developed. includes numerous relevant case studies to enhance studentunderstanding no prior knowledge of protein structure is assumed

Separation Processes in the Food and Biotechnology Industries

Author: A S Grandison
Publisher: Elsevier
ISBN: 1855736578
Format: PDF, Mobi
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This book reviews methods and techniques for separating food components and products of the biotechnology industry. The introduction focuses on food composition and some of the conventional separation techniques. Subsequent chapters deal with each specific type or area of application individually and include information on the basic principles, industrial equipment available, commercial applications and an overview of research and development.

Immobilisierte Biokatalysatoren

Author: Winfried Hartmeier
Publisher: Springer-Verlag
ISBN: 3662078627
Format: PDF, ePub
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Obwohl oder gerade weil eine kaum mehr überschaubare Zahl von Publi kationen auf dem Gebiet der Immobilisierung von Biokatalysatoren existiert, ist es für den Anfänger, der einen Einstieg sucht, auf diesem Gebiet oft schwer, geeignete Informationen aus der Flut von Originalarbeiten herauszufinden. Einige gute, fast immer aber eng lischsprachige Monographien sind entweder außerordentlich umfang reich und teuer, oder sie behandeln nur ausgewählte Teilaspekte der Immobilisierung. Dem will die vorliegende Einführung abhelfen. Sie soll dem Leser zu einem raschen Überblick verhelfen und ihm den inzwischen abgesicherten Kenntnisstand nach Art eines kurzen Lehr buches vermitteln. Das Buch ist aus Erfahrungen in Vorlesungen, Praktika und Kursen entstanden. Es soll sich maßgeblich an Lernende wenden, auch wenn "Immobilisierte Biokatalysatoren" bisher noch nicht zum Stan dardrepertoire der Lehre an deutschen Universitäten und Fachhoch schulen gehören. Es ist jedoch die Oberzeugung des Autors, daß sich dies in den kommenden Jahren mit der wachsenden Bedeutung dieses Gebietes und mit der allgemeinen Etablierung der Biotechnologie an den Hochschulen ändern wird. Ober den Kreis der Studenten und Dozen ten hinaus wendet sich die Einführung aber auch an die vielen Natur wissenschaftler und Techniker der industriellen Praxis, die sich mit immobilisierten Biokatalysatoren befassen und sich dazu ein ent sprechendes Grundwissen aneignen wollen.