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Process Validation in Manufacturing of Biopharmaceuticals
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 conc...
Clojure in Action
Summary Clojure in Action is a hands-on tutorial for the working programmer who has written code in a language like Java or Ruby, but has no prior experience with Lisp. It teaches Clojure from the basics to advanced topics using practical, real-world application examples. Blow through the theory and dive into practical matters like unit-testing and environment set-up, all the way through building a scalable web-application using domain-specific languages, Hadoop, HBase, and RabbitMQ. About the Technology Clojure is a modern Lisp for the JVM, and it has the strengths you'd expect: first-class functions, macros, support for functional programming, and a Lisp-like, clean programming style. Abou...
Evidence-Based Cybersecurity
The prevalence of cyber-dependent crimes and illegal activities that can only be performed using a computer, computer networks, or other forms of information communication technology has significantly increased during the last two decades in the USA and worldwide. As a result, cybersecurity scholars and practitioners have developed various tools and policies to reduce individuals' and organizations' risk of experiencing cyber-dependent crimes. However, although cybersecurity research and tools production efforts have increased substantially, very little attention has been devoted to identifying potential comprehensive interventions that consider both human and technical aspects of the local ...
A Philosophy of Autobiography
This book offers intimate readings of a diverse range of global autobiographical literature with an emphasis on the (re)presentation of the physical body. The twelve texts discussed here include philosophical autobiography (Nietzsche), autobiographies of self-experimentation (Gandhi, Mishima, Warhol), literary autobiography (Hemingway, Das) as well as other genres of autobiography, including the graphic novel (Spiegelman, Satrapi), as also documentations of tragedy and injustice and subsequent spiritual overcoming (Ambedkar, Pawar, Angelou, Wiesel). In exploring different literary forms and orientations of the autobiographies, the work remains constantly attuned to the physical body, a focus...
The Great Mughals and their India
A definitive, comprehensive and engrossing chronicle of one of the greatest dynasties of the world – the Mughal – from its founder Babur to Bahadur Shah Zafar, the last of the clan The magnificent Mughal legacy – the world-famous Taj Mahal being the most prominent among countless other examples – is an inexhaustible source of inspiration to historians, writers, moviemakers, artists and ordinary mortals alike. Mughal history abounds with all the ingredients of classical drama: ambition and frustration, hope and despair, grandeur and decline, love and hate, and loyalty and betrayal. In other words: it is great to read and offers ample food for thought on the human condition. Much more ...
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition
Process Validation in Manufacturing of Biopharmaceuticals, Third Edition delves into the key aspects and current practices of process validation. It includes discussion on the final version of the FDA 2011 Guidance for Industry on Process Validation Principles and Practices, commonly referred to as the Process Validation Guidance or PVG, issued in final form on January 24, 2011. The book also provides guidelines and current practices, as well as industrial case studies illustrating the different approaches that can be taken for successful validation of biopharmaceutical processes. Case studies include Process validation for membrane chromatography Leveraging multivariate analysis tools to qu...
Quality by Design for Biopharmaceuticals
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life c...
Microbial Production of High-Value Products
This edited volume emphasizes how microorganisms have become a reliable pillar of biotechnology. The authors discuss advances in synthetic biology and genetic engineering that have made it possible to reprogram the microbial cellular capabilities. This enables an economically viable production of high-value products at an industrial level. The first part of the book provides an overview of synthetic biology and genome editing tools for engineering microbial cell factories in modern fermentation. Readers also learn how high-throughput bioprocessing methods are used to recover and purify microbial products. The remaining parts of this book explore the implementation and challenges of these upstream and downstream processing techniques for manufacturing high-value products. Cost-effectiveness and quality-control are key factors, when discussing the production of low-molecular-weight products, biopharmaceuticals, biopolymers and protein-based nanoparticles. This book is a valuable resource for biotechnologists both in the industry and in academia.
Scale-Up and Optimization in Preparative Chromatography
Presenting guidelines to predict and improve separation system performance, this book contains numerous case studies illustrating the practice of scale-up principles in process development. It offers solutions to limitations that occur in real-world purification schemes; methods to model, optimize, and characterize nonlinear separation processes; d
WITH LOVE FROM ISRAEL
After floating in the Dead Sea, the six friends came out and started walking on the shore towards salt formations at a distance. Amyra and two girls were leading. Aghast they stopped abruptly, to see a thickset man holding a girl in bikinis and pushing her towards a fold in the piled-up salt formations. It infuriated Capt Shaurya Vardhan who saw the man with an arm-hold around the girl’s neck, flaunting a knife blade in his other hand. The girl was struggling and whimpering to let her go. The man was heard saying, ‘Co-operate with me and I won’t hurt you. Shaurya warned the goon in his deep voice, ‘stop there you rascal.’ Surprised, the man whirled around to face the challenger with a speed of a cobra stepped over. He shoved the girl behind him and came at the Captain, raising the knife aiming at his chest.
