Download or read book Formulation of Monoclonal Antibody Therapies written by Amal Ali Elkordy and published by Academic Press. This book was released on 2023-05-20 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies, and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. It also covers the industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases, and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences. Covers details of recent advances in using mAbs Examines how to overcome the challenges for formulations of therapeutic mAbs Includes clinical application of mAbs

Download or read book Monoclonal Antibodies written by Steven Shire and published by Woodhead Publishing. This book was released on 2015-04-24 with total page 224 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. Discusses the challenges to develop MAbs for intravenous (IV) and subcutaneous delivery (SC) Presents strategies to meet the challenges in development of MAbs for SC and IV administration Discusses the use of biophysical analytical tools coupled with MAb engineering to understand what governs MAb properties at high concentration

Download or read book Therapeutic Monoclonal Antibodies written by Zhiqiang An and published by John Wiley & Sons. This book was released on 2011-09-20 with total page 932 pages. Available in PDF, EPUB and Kindle. Book excerpt: 70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.

Download or read book Current Trends in Monoclonal Antibody Development and Manufacturing written by Steven J. Shire and published by Springer Science & Business Media. This book was released on 2009-11-11 with total page 348 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Download or read book Monoclonal Antibody Directed Therapy written by Veysel Kayser and published by Mdpi AG. This book was released on 2022-01-28 with total page 144 pages. Available in PDF, EPUB and Kindle. Book excerpt: The book deals with therapeutic monoclonal antibodies (mAbs) broadly, and relevant topics such as challenges and opportunities, next-generation antibody products, Antibody-Drug-Conjugates (ADC), bispecifics, glycosylation, and T-cell engagers are covered. Each topic has been written by leading groups around the world and the book should be of interest to researchers from both academia and industry.

Download or read book Development of Biopharmaceutical Drug Device Products written by Feroz Jameel and published by Springer Nature. This book was released on 2020-03-13 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Download or read book Safety of Biologics Therapy written by Brian A. Baldo and published by Springer. This book was released on 2016-08-12 with total page 610 pages. Available in PDF, EPUB and Kindle. Book excerpt: This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences.

Download or read book Antibody Drug Discovery written by Clive R Wood and published by World Scientific. This book was released on 2011-12-02 with total page 490 pages. Available in PDF, EPUB and Kindle. Book excerpt: Monoclonal antibodies have become important treatments for cancer, inflammation and a wide range of other diseases, representing an increasing share of the most successful pharmaceutical markets. The technologies to discover these drugs have been developed by select centers of excellence in industry and academia, and are continually being fine tuned in the race to identify the best antibody-based drug candidates and accelerate their paths to patients. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field and to offer specialized perspectives to established researchers. The chapters set into context the significance of key developments and important considerations for selecting different approaches, such as antibody humanization, isotype selection, lead candidate selection criteria and protein production. All contributors to this work are experts in their fields, and many have played pivotal roles in the creation of these technologies./a

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 Formulation Characterization and Stability of Protein Drugs written by Rodney Pearlman and published by Springer Science & Business Media. This book was released on 2006-04-11 with total page 432 pages. Available in PDF, EPUB and Kindle. Book excerpt: Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Download or read book Monoclonal Antibodies Meeting the Challenges in Manufacturing Formulation Delivery and Stability of Final Drug Product written by and published by . This book was released on with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Antibody Mediated Drug Delivery Systems written by Yashwant V. Pathak and published by John Wiley & Sons. This book was released on 2012-05-15 with total page 542 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book covers various aspects of antibody mediated drug delivery systems – theoretical aspects, processing, viral and non-viral vectors, and fields where these systems find and /or are being evaluated for applications as therapeutics and diagnostic treatment. Chapters discuss actual applications of techniques used for formulation and characterization. Applications areas include cancer, pulmonary, ocular diseases; brain drug delivery; and vaccine delivery. The contributing authors represent over 10 different countries, covering recent developments happening around the globe.

Download or read book Therapeutic Antibody Engineering written by William R Strohl and published by Elsevier. This book was released on 2012-10-16 with total page 697 pages. Available in PDF, EPUB and Kindle. Book excerpt: The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships Integration of knowledge across all areas of antibody engineering, development, and marketing Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity

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 752 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 Bioconjugate Techniques written by Greg T. Hermanson and published by Academic Press. This book was released on 2010-07-26 with total page 1233 pages. Available in PDF, EPUB and Kindle. Book excerpt: Bioconjugate Techniques, 2nd Edition, is the essential guide to the modification and cross linking of biomolecules for use in research, diagnostics, and therapeutics. It provides highly detailed information on the chemistry, reagent systems, and practical applications for creating labeled or conjugate molecules. It also describes dozens of reactions with details on hundreds of commercially available reagents and the use of these reagents for modifying or cross linking peptides and proteins, sugars and polysaccharides, nucleic acids and oligonucleotides, lipids, and synthetic polymers. A one-stop source for proven methods and protocols for synthesizing bioconjugates in the lab Step-by-step presentation makes the book an ideal source for researchers who are less familiar with the synthesis of bioconjugates More than 600 figures that visually describe the complex reactions associated with the synthesis of bioconjugates Includes entirely new chapters on the latest areas in the field of bioconjugation as follows: Microparticles and nanoparticlesSilane coupling agentsDendrimers and dendronsChemoselective ligationQuantum dotsLanthanide chelatesCyanine dyesDiscrete PEG compoundsBuckyballs,fullerenes, and carbon nanotubesMass tags and isotope tagsBioconjugation in the study of protein interactions

Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel and published by John Wiley & Sons. This book was released on 2010-07-13 with total page 986 pages. Available in PDF, EPUB and Kindle. Book excerpt: A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Download or read book Therapeutic Monoclonal Antibodies From Lot Release to Stability Testing written by Harleen Kaur and published by Elsevier. This book was released on 2024-06-15 with total page 174 pages. Available in PDF, EPUB and Kindle. Book excerpt: Therapeutic Monoclonal Antibodies and Antibody Drug Conjugates (ADC): From Lot Release to Stability Testing is a highly topical resource on a subject of interest for scientists and researchers working on monoclonal antibodies' characterization, release testing, stability testing and similarity assessments of monoclonal antibodies in the biopharmaceutical industry. Monoclonal antibodies (mAbs) are large, extremely complex and dynamic biomolecules, so it can be challenging to develop well-characterized therapeutic antibodies that meet regulatory expectations that are also inline with commercialized standards for different drug markets. Lot release testing and understanding the stability of the mAb over a period of time, and in different environmental conditions, is an indispensable aspect of mAb physicochemical characterization. This book covers the process, including extensive analysis that starts with quantifying the purity attribute to glycan profiling and identifying the mAb primary structure. The book has a primary purpose of focusing on both Lot release testing and stability testing of monoclonal antibodies (subjects not covered in any great detail in other books). Discusses, in detail, the Lot release methods for both drug substance and drug product, along with their importance in process sample analysis Gives specific attention to general characteristics tests, such as pH determination, osmolality, sub-visible particle count, appearance and visible tests, and regulatory/pharmacopeial guidelines Includes different kinds of stability testing (real time, accelerated and stressed) and their importance and determinations on product shelf life Presents regulatory guidelines on ICH Q2R1, ICHQ6B and ICHQ5C, which are discussed along with analytical method validation, monoclonal antibodies physicochemical characterization and stability testing Provides different characterization methods and validation and development case studies of monoclonal antibodies, including biosimilars and innovators