Download or read book Cost Modeling for Monoclonal Antibody Manufacturing written by Christina Margaret Simpson and published by . This book was released on 2011 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt: The Novartis BioPharmOps division is responsible for manufacturing large molecule products, including monoclonal antibodies, for late stage clinical trials and commercial sales. The BioPharmOps site in Huningue, France is expanding their product line but is also trying to reduce costs; cost pressures are increasing as biotech products become a larger part of Novartis' pipeline. The site uses a standard cost method to calculate their product costs. However, when using standard costs it can be time-consuming to extrapolate and predict costs when inputs and assumptions (such as product mix or process parameters) are changed. This project describes development of a model that allows the factory to quickly and easily simulate new product mixes and process flows. This model provides the site with a different view of their costs that will help them understand their cost drivers more completely and thereby help enable strategic decision-making at the site. A model of this type can be used to provide unexpected insights but the data in it are not meant to stand alone. By using results from a cost model like this along with operational metrics like throughput time or changeover time, a site should be able to quickly predict the cost impact of process changes or changes in the production plan.
Download or read book Monoclonal Antibody Production written by National Research Council and published by National Academies Press. This book was released on 1999-05-06 with total page 74 pages. Available in PDF, EPUB and Kindle. Book excerpt: The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that "the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced." On March 26, 1998, AAVS submitted a second petition, stating that "NIH failed to provide valid scientific reasons for not supporting a proposed ban." The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop.
Download or read book Modeling and Economic Evaluation of Early Stage Clinical Monoclonal Antibody Manufacturing Using Single Use Technology written by Daniel Evan Kress and published by . This book was released on 2015 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt: A critical cost driver in the product development process is the manufacturing of clinical trial material supplies. The clinical manufacturing process operates under similar regulatory burdens as commercial biopharmaceutical manufacturing, but must operate with a high degree of flexibility to respond to emerging data from ongoing clinical programs and competitive intelligence. This project investigates the current state of clinical monoclonal antibody (mAb) manufacturing and generates possible future states for low-cost, flexible manufacturing. Pfizer currently has a world-class clinical manufacturing facility in St. Louis, MO, and forecasts have not predicted sufficient growth in the market to justify additional facilities under the current strategy. However, with many other companies turning to single-use technology, Pfizer would like to consider the benefits of a new low-cost, flexible facility for the benefits of flexibility and faster speed to market. A high-level facility model includes capital costs, technical specifications, and a dynamic view of the operational costs based on product attributes. This model shows that a campaign cost of less than $2.6M can be achieved with only 3 projects per year, which represents a facility utilization of less than 40%. At a loading of 4 campaigns per year, this facility would have a payback period of less than 3 years. The conservative facility design shows how capacity can be added with a low operational cost and less than $5M of overhead per year. Business factors such as pipeline prospects and availability of capital may prevent execution of the project in the near term, but investment in single-use equipment is advisable to gain experience in technologies that are likely to play a large part in biopharmaceutical manufacturing in the future.
Download or read book A Systematic Framework to Optimize and Control Monoclonal Antibody Manufacturing Process written by Ying Fei Li and published by . This book was released on 2018 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: In this work, by utilizing multiple modeling approaches, we have developed a systematic framework to optimize and control monoclonal antibody manufacturing process. In our first study, we leverage DoE-PCA approach to unambiguously identify critical process parameters to improve process yield and cost of goods, followed by the use of Monte Carlo simulation to validate the impact of parameters on these attributes. In our second study, we use a Bayesian approach to predict product quality for future manufacturing batches, and hence mitigation strategies can be put in place if the data suggest a potential deviation. Finally, we use neural network model to accurately characterize the impurity reduction of each purification step, and ultimately use this model to develop acceptance criteria for the feed based on the predetermined process specifications. Overall, the work in this thesis demonstrates that the framework is powerful and more reliable for process optimization, monitoring and control.
Download or read book Process Scale Purification of Antibodies written by Uwe Gottschalk and published by John Wiley & Sons. This book was released on 2017-03-07 with total page 849 pages. Available in PDF, EPUB and Kindle. Book excerpt: Promoting a continued and much-needed renaissance in biopharmaceutical manufacturing, this book covers the different strategies and assembles top-tier technology experts to address the challenges of antibody purification. • Updates existing topics and adds new ones that include purification of antibodies produced in novel production systems, novel separation technologies, novel antibody formats and alternative scaffolds, and strategies for ton-scale manufacturing • Presents new and updated discussions of different purification technologies, focusing on how they can address the capacity crunch in antibody purification • Emphasizes antibodies and innovative chromatography methods for processing
Download or read book Process Control Intensification and Digitalisation in Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2021-12-20 with total page 404 pages. Available in PDF, EPUB and Kindle. Book excerpt: Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing Explore new trends in continuous biomanufacturing with contributions from leading practitioners in the field With the increasingly widespread acceptance and investment in the ??technology, the last decade has demonstrated the utility of continuous ??processing in the pharmaceutical industry. In Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing, distinguished biotechnologist Dr. Ganapathy Subramanian delivers a comprehensive exploration of the potential of the continuous processing of biological products and discussions of future directions in advancing continuous processing to meet new challenges and demands in the manufacture of therapeutic products. A stand-alone follow-up to the editor’s Continuous Biomanufacturing: Innovative Technologies and Methods published in 2017, this new edited volume focuses on critical aspects of process intensification, process control, and the digital transformation of biopharmaceutical processes. In addition to topics like the use of multivariant data analysis, regulatory concerns, and automation processes, the book also includes: Thorough introductions to capacitance sensors to control feeding strategies and the continuous production of viral vaccines Comprehensive explorations of strategies for the continuous upstream processing of induced microbial systems Practical discussions of preparative hydrophobic interaction chromatography and the design of modern protein-A-resins for continuous biomanufacturing In-depth examinations of bioprocess intensification approaches and the benefits of single use for process intensification Perfect for biotechnologists, bioengineers, pharmaceutical engineers, and process engineers, Process Control, Intensification, and Digitalisation in Continuous Biomanufacturing is also an indispensable resource for chemical engineers seeking a one-stop reference on continuous biomanufacturing.
Download or read book Approaches to the Purification Analysis and Characterization of Antibody Based Therapeutics written by Allan Matte and published by Elsevier. This book was released on 2020-09-07 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: Approaches to the Purification, Analysis and Characterization of Antibody-Based Therapeutics provides the interested and informed reader with an overview of current approaches, strategies and considerations relating to the purification, analytics and characterization of therapeutic antibodies and related molecules. While there are obviously other books published in and around this subject area, they seem to be either older (c.a. year 2000 publication date) or are more limited in scope. The book will include an extensive bibliography of the published literature in the respective areas covered. It is not, however, intended to be a how-to methods book. Covers the vital new area of R&D on therapeutic antibodies Written by leading scientists and researchers Up-to-date coverage and includes a detailed bibliography
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 Handbook of Therapeutic Antibodies written by Stefan Dübel and published by John Wiley & Sons. This book was released on 2014-12-03 with total page 2538 pages. Available in PDF, EPUB and Kindle. Book excerpt: Dieses Nachschlagewerk zu therapeutischen Antikörpern sucht auch in der komplett überarbeiteten 2. Auflage seinesgleichen und bietet 30 % neue Inhalte zu Entwicklung, Herstellung und therapeutischen Anwendungen dieser Biomoleküle.
Download or read book Perspectives in Life Cycle Impact Assessment written by Patrick Hofstetter and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Perspectives in Life Cycle Impact Assessment: A Structured Approach to Combine Models of the Technosphere, Ecosphere and Valuesphere describes the relationship between subjective and objective elements in Life Cycle Impact Assessment. It suggests a new framework which will allow people to master two of the major problems associated with LCA, the difficulty of separating subjective from objective elements and the tendency for impact assessment to record `phantoms' rather than actual damages. Perspectives in Life Cycle Impact Assessment: A Structured Approach to Combine Models of the Technosphere, Ecosphere and Valuesphere presents a proposal for a second generation framework and method for Life Cycle Impact Assessment. Many of the suggested elements are either based on other tools for environmental analysis, e.g. risk assessment, or fit in well with tools and concepts such as industrial ecology, technology assessment, or environmental impact assessment. The research presented in this book goes beyond the scope of presently used methods for Life Cycle Assessment and may stimulate new developments in a variety of areas. The book will appeal to persons from a wide range of scientific disciplines who are interested in learning more about Life Cycle Assessment. It will be especially valuable to members of SETAC and to students and researchers in the fields of environmental impact assessment, risk assessment and industrial ecology.
Download or read book Pharmaceutical Medicine and Translational Clinical Research written by Divya Vohora and published by Academic Press. This book was released on 2017-11-14 with total page 527 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical Medicine and Translational Clinical Research covers clinical testing of medicines and the translation of pharmaceutical drug research into new medicines, also focusing on the need to understand the safety profile of medicine and the benefit-risk balance. Pharmacoeconomics and the social impact of healthcare on patients and public health are also featured. It is written in a clear and straightforward manner to enable rapid review and assimilation of complex information and contains reader-friendly features.As a greater understanding of these aspects is critical for students in the areas of pharmaceutical medicine, clinical research, pharmacology and pharmacy, as well as professionals working in the pharmaceutical industry, this book is an ideal resource. Includes detailed coverage of current trends and key topics in pharmaceutical medicine, including biosimilars, biobetters, super generics, and Provides a comprehensive look at current and important aspects of the science and regulation of drug and biologics discovery
Download or read book Green Chemistry in the Pharmaceutical Industry written by Peter J. Dunn and published by John Wiley & Sons. This book was released on 2010-02-02 with total page 388 pages. Available in PDF, EPUB and Kindle. Book excerpt: Edited by three of the world's leading pharmaceutical scientists, this is the first book on this important and hot topic, containing much previously unpublished information. As such, it covers all aspects of green chemistry in the pharmaceutical industry, from simple molecules to complex proteins, and from drug discovery to the fate of pharmaceuticals in the environment. Furthermore, this ready reference contains several convincing case studies from industry, such as Taxol, Pregabalin and Crestor, illustrating how this multidisciplinary approach has yielded efficient and environmentally-friendly processes. Finally, a section on technology and tools highlights the advantages of green chemistry.
Download or read book Continuous Biomanufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2017-12-26 with total page 628 pages. Available in PDF, EPUB and Kindle. Book excerpt: This is the most comprehensive treatise of this topic available, providing invaluable information on the technological and economic benefits to be gained from implementing continuous processes in the biopharmaceutical industry. Top experts from industry and academia cover the latest technical developments in the field, describing the use of single-use technologies alongside perfusion production platforms and downstream operations. Special emphasis is given to process control and monitoring, including such topics as 'quality by design' and automation. The book is supplemented by case studies that highlight the enormous potential of continuous manufacturing for biopharmaceutical production facilities.
Download or read book Antibody Drug Discovery written by Clive R. Wood and published by World Scientific. This book was released on 2012 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology.
Download or read book Continuous Processing in Pharmaceutical Manufacturing written by Ganapathy Subramanian and published by John Wiley & Sons. This book was released on 2015-02-09 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.
Download or read book Single Use Technology in Biopharmaceutical Manufacture written by Regine Eibl and published by John Wiley & Sons. This book was released on 2019-07-18 with total page 368 pages. Available in PDF, EPUB and Kindle. Book excerpt: Authoritative guide to the principles, characteristics, engineering aspects, economics, and applications of disposables in the manufacture of biopharmaceuticals The revised and updated second edition of Single-Use Technology in Biopharmaceutical Manufacture offers a comprehensive examination of the most-commonly used disposables in the manufacture of biopharmaceuticals. The authors—noted experts on the topic—provide the essential information on the principles, characteristics, engineering aspects, economics, and applications. This authoritative guide contains the basic knowledge and information about disposable equipment. The author also discusses biopharmaceuticals’ applications through the lens of case studies that clearly illustrate the role of manufacturing, quality assurance, and environmental influences. This updated second edition revises existing information with recent developments that have taken place since the first edition was published. The book also presents the latest advances in the field of single-use technology and explores topics including applying single-use devices for microorganisms, human mesenchymal stem cells, and T-cells. This important book: • Contains an updated and end-to-end view of the development and manufacturing of single-use biologics • Helps in the identification of appropriate disposables and relevant vendors • Offers illustrative case studies that examine manufacturing, quality assurance, and environmental influences • Includes updated coverage on cross-functional/transversal dependencies, significant improvements made by suppliers, and the successful application of the single-use technologies Written for biopharmaceutical manufacturers, process developers, and biological and chemical engineers, Single-Use Technology in Biopharmaceutical Manufacture, 2nd Edition provides the information needed for professionals to come to an easier decision for or against disposable alternatives and to choose the appropriate system.
Download or read book Instrumentation and Sensors for the Food Industry written by E Kress-Rogers and published by Woodhead Publishing. This book was released on 2001-10-03 with total page 878 pages. Available in PDF, EPUB and Kindle. Book excerpt: This collection of 23 contributions reviews the most common instruments for measuring food quality both on the processing line and in the laboratory. Each chapter describes an instrument's underlying principles with emphasis on aspects relevant to food applications, identifies the significance of the variables measured, and assesses the accuracy of the technique for specific food groups. The second edition adds eight chapters. Annotation copyrighted by Book News Inc., Portland, OR.
