Preparative Chromatography for Separation of Proteins addresses a wide range of modeling, techniques, strategies, and case studies of industrial separation of proteins and peptides. • Covers broad aspects of preparative chromatography with a unique combination of academic and industrial perspectives • Presents Combines modeling with compliantce useing of Quality-by-Design (QbD) approaches including modeling • Features a variety of chromatographic case studies not readily accessible to the general public • Represents an essential reference resource for academic, industrial, and pharmaceutical researchers
Discover the power of (finally) getting unstuck, claiming your clarity, and becoming the person whose life you want to live–all through a simple self-care practice you can build into your daily routine. For anyone who's trying to make sense of their life, who wants to get unstuck from the patterns that hold them back, hear this incredible news: everything you need for the freedom you want is entirely within reach. This practice and pathway is free, it's readily available every day of your life, it takes just minutes of your time, and anyone can do it. Author, writing coach, and speaker Allison Fallon's life transformed when she discovered the power of a daily writing practice. As it turns out, using your words is one of the most powerful means you have for unlocking your life. The Power of Writing It Down is your guide to this transformative tool available to us all. In as little as five to twenty minutes a day, scientific research shows this daily practice can help you: Identify your ruts and create new neurological grooves toward better habits Find fresh motivation and take ownership of your life Heal from past pain and trauma Relieve anxiety and depression Contextualize life's setbacks and minor frustrations Live a more confident, balanced, and healthy life …and so much more Drawing from years of coaching hundreds through the writing process–from first-timers to New York Times bestselling authors–Allison shares tried and tested practices for getting started, staying inspired, and using this simple habit to shift how you feel and show up to your life. Pen and paper is simply the method, but the reward is the real magic: new depths of self-discovery, creativity, and intentionality for living.
This book examines statistical techniques that are critically important to Chemistry, Manufacturing, and Control (CMC) activities. Statistical methods are presented with a focus on applications unique to the CMC in the pharmaceutical industry. The target audience consists of statisticians and other scientists who are responsible for performing statistical analyses within a CMC environment. Basic statistical concepts are addressed in Chapter 2 followed by applications to specific topics related to development and manufacturing. The mathematical level assumes an elementary understanding of statistical methods. The ability to use Excel or statistical packages such as Minitab, JMP, SAS, or R will provide more value to the reader. The motivation for this book came from an American Association of Pharmaceutical Scientists (AAPS) short course on statistical methods applied to CMC applications presented by four of the authors. One of the course participants asked us for a good reference book, and the only book recommended was written over 20 years ago by Chow and Liu (1995). We agreed that a more recent book would serve a need in our industry. Since we began this project, an edited book has been published on the same topic by Zhang (2016). The chapters in Zhang discuss statistical methods for CMC as well as drug discovery and nonclinical development. We believe our book complements Zhang by providing more detailed statistical analyses and examples.
Since the introduction of recombinant human growth hormone and insulin a quarter century ago, protein therapeutics has greatly broadened the ho- zon of health care. Many patients suffering with life-threatening diseases or chronic dysfunctions, which were medically untreatable not long ago, can attest to the wonder these drugs have achieved. Although the ?rst generation of p- tein therapeutics was produced in recombinant Escherichia coli, most recent products use mammalian cells as production hosts. Not long after the ?rst p- duction of recombinant proteins in E. coli, it was realized that the complex tasks of most post-translational modi?cations on proteins could only be ef?ciently carried out in mammalian cells. In the 1990s, we witnessed a rapid expansion of mammalian-cell-derived protein therapeutics, chie?y antibodies. In fact, it has been nearly a decade since the market value of mammalian-cell-derived protein therapeutics surpassed that of those produced from E. coli. A common characteristic of recent antibody products is the relatively large dose required for effective therapy, demanding larger quantities for the treatment of a given disease. This, coupled with the broadening repertoire of protein drugs, has rapidly expanded the quantity needed for clinical applications. The increasing demand for protein therapeutics has not been met exclusively by construction of new manufacturing plants and increasing total volume capacity. More - portantly the productivity of cell culture processes has been driven upward by an order of magnitude in the past decade.
Biopharmaceuticals, medicines made by or from living organisms (including cells from living organisms), are extremely effective in treating a broad range of diseases. Their importance to human health has grown significantly over the years as more biopharmaceutical products have entered the market, and now the biggest selling drugs in the world are biopharmaceuticals. Biopharmaceutical Manufacturing: Principles, Processes and Practices provides concise, comprehensive, and up-to-date coverage of biopharmaceutical manufacturing. Written in a clear and informal style, the content has been influenced by the authors’ substantial industry experience and teaching expertise. That expertise enables the authors to address the many questions posed over the years both by university students and professionals with experience in the field. Consequently, the book will appeal both to undergraduate or graduate students using it as a textbook and specialized industry practitioners seeking to understand the big picture of biopharmaceutical manufacturing. This book:
Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry
This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Modern manufacturing systems must be engineered as any other complex systems, especially in the context of their integration. The book first presents the all-embracing concept of the Extended Enterprise as way of inter-enterprise integration. It then focusses on Enterprise Engineering methods and tools to address intra-enterprise integration using a model-based approach. Business process modelling and re-engineering isssues are particularly discussed and tools presented. Formal specification and Petri net-based analysis methods for manufacturing systems complete the set of tools for Enterprise Engineering. Coordination and integration issues of manufacturing systems and their business processes are then covered and examples of integration platforms presented. Finally, standardization and pre-standardization issues related to enterprise modelling and integration conclude the book.
Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.
Networks of Innovation offers a historical perspective on the manner in which private sector organizations have acquired, sustained, and periodically lost the ability to develop, manufacture, and market new serum antitoxins and vaccines. The primary focus is on the H. K. Mulford Company, on Sharp & Dohme, which acquired Mulford in 1929, and on Merck & Co., Inc., which merged with Sharp & Dohme in 1953. By surveying a century of innovation in biologicals, the authors show how the activities of these three commercial enterprises were related to a series of complex, evolving networks of scientific, governmental, and medical institutions in the United States and abroad.
