Advanced Biologic Drugs And Manufacturing Process

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Advanced Biologic Drugs And Manufacturing Process
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Author : Basanta Kumara Behera
language : en
Publisher: Elsevier
Release Date : 2024-05-10
Advanced Biologic Drugs And Manufacturing Process written by Basanta Kumara Behera and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-05-10 with Science categories.
Advanced Biologic Drugs and Manufacturing Process explains biologic drugs, their pharmaceutical charters, and their significance in curing life-threatening chronic diseases. It also provides the latest information on the use of biological drugs for the treatment of numerous diseases and conditions and their most advanced therapies available, including how biologics have impacted cancer therapy, delayed or reversed the course of immune-related conditions, and changed the lives of those with rare chronic diseases. In addition, the book explains how immunotherapy is used for the treatment of diseases by activating or suppressing the immune system.Scientists working on the front lines in the biotechnology industry are provided with an overview on stable production processes and how to monitor the value chain transfer process of biologic drug for better return, in terms of profit. The book also helps researchers and academics on how to develop and update protocols related to testing, quality control, and quality assurance to obtain highly purified biopharmaceuticals or vaccines. - Gives insights into the conceptual strategic drive for manufacturing innovative, biologically derived therapeutic compounds to launch for commercial purposes - Focuses on how to execute biopharmaceutical portfolio trends to bring sustainable manufacturing processes per the guidelines of international regulatory acts - Highlights the emerging trends in medical sciences on tissue engineering, regenerative medicine, personalized medicines, and various innovative technique on immunotherapy to fight against life-threatening diseases
Rare Diseases And Orphan Products
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Author : Institute of Medicine
language : en
Publisher: National Academies Press
Release Date : 2011-04-03
Rare Diseases And Orphan Products written by Institute of Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-04-03 with Medical categories.
Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.
Advanced Biologic Drugs And Manufacturing Process
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Author : Basanta Kumara Behera
language : en
Publisher: Academic Press
Release Date : 2024-06-01
Advanced Biologic Drugs And Manufacturing Process written by Basanta Kumara Behera and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-06-01 with Science categories.
Advanced Biologic Drugs and Manufacturing Process explains in detail biologic drugs and their pharmaceutical charters and their significance in curing life-threatening chronic diseases. It also provides the latest information on the use of biological drugs for the treatment of numerous diseases and conditions and their most advanced therapies available, including how biologics have impacted cancer therapy, delayed or reversed the course of immune-related conditions, and changed the lives of those with rare chronic diseases. In addition, the book explains how immunotherapy is used for the treatment of diseases by activating or suppressing the immune system and how to find a way to more treatment options and access life-saving biologic drugs at a reasonable budget or to develop a generic version of a reference a biologic drug. Scientists working on the front lines in the biotechnology industry are provided with an overview on stable production processes and how to monitor the value chain transfer process of biologic drug for better return, in terms of profit. The book also helps researchers and academics on how to develop and update protocols related to testing, quality control, and quality assurance to obtain highly purified biopharmaceuticals or vaccines.
Biologics Biosimilars And Biobetters
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Author : Iqbal Ramzan
language : en
Publisher: John Wiley & Sons
Release Date : 2021-02-03
Biologics Biosimilars And Biobetters written by Iqbal Ramzan and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-02-03 with Medical categories.
A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists
Pharmaceutical Quality By Design
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Author : Walkiria S. Schlindwein
language : en
Publisher: John Wiley & Sons
Release Date : 2018-03-19
Pharmaceutical Quality By Design written by Walkiria S. Schlindwein and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-03-19 with Science categories.
A practical guide to Quality by Design for pharmaceutical product development Pharmaceutical Quality by Design: A Practical Approach outlines a new and proven approach to pharmaceutical product development which is now being rolled out across the pharmaceutical industry internationally. Written by experts in the field, the text explores the QbD approach to product development. This innovative approach is based on the application of product and process understanding underpinned by a systematic methodology which can enable pharmaceutical companies to ensure that quality is built into the product. Familiarity with Quality by Design is essential for scientists working in the pharmaceutical industry. The authors take a practical approach and put the focus on the industrial aspects of the new QbD approach to pharmaceutical product development and manufacturing. The text covers quality risk management tools and analysis, applications of QbD to analytical methods, regulatory aspects, quality systems and knowledge management. In addition, the book explores the development and manufacture of drug substance and product, design of experiments, the role of excipients, multivariate analysis, and include several examples of applications of QbD in actual practice. This important resource: Covers the essential information about Quality by Design (QbD) that is at the heart of modern pharmaceutical development Puts the focus on the industrial aspects of the new QbD approach Includes several illustrative examples of applications of QbD in practice Offers advanced specialist topics that can be systematically applied to industry Pharmaceutical Quality by Design offers a guide to the principles and application of Quality by Design (QbD), the holistic approach to manufacturing that offers a complete understanding of the manufacturing processes involved, in order to yield consistent and high quality products.
Navigating The Manufacturing Process And Ensuring The Quality Of Regenerative Medicine Therapies
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Author : National Academies of Sciences, Engineering, and Medicine
language : en
Publisher: National Academies Press
Release Date : 2018-01-29
Navigating The Manufacturing Process And Ensuring The Quality Of Regenerative Medicine Therapies written by National Academies of Sciences, Engineering, and Medicine and has been published by National Academies Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-01-29 with Medical categories.
On June 26, 2017, the Forum on Regenerative Medicine hosted a public workshop in Washington, DC, titled Navigating the Manufacturing Process and Ensuring the Quality of Regenerative Medicine Therapies in order to examine and discuss the challenges, opportunities, and best practices associated with defining and measuring the quality of cell and tissue products and raw materials in the research and manufacturing of regenerative medicine therapies. The goal of the workshop was to learn from existing examples of the manufacturing of early-generation regenerative medicine products and to address how progress could be made in identifying and measuring critical quality attributes. The workshop also addressed the challenges of designing and adhering to standards as a way of helping those who are working to scale up processes and techniques from a research laboratory to the manufacturing environment. This publication summarizes the presentations and discussions from the workshop.
Biopharma Revolution Exploring The Nexus Of Biotechnology And Pharmacology
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Author : Aliasghar Tabatabaei Mohammadi
language : en
Publisher: Nobel Sciences
Release Date : 2024-11-01
Biopharma Revolution Exploring The Nexus Of Biotechnology And Pharmacology written by Aliasghar Tabatabaei Mohammadi and has been published by Nobel Sciences this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-11-01 with Medical categories.
Chapters Chapter 1: Exploring the Nexus of Biotechnology and Psychopharmacology to treat mental disorder by concentration on substance use disorder Chapter 2: Biotechnology and Pharmacology: A Powerful Confluence of Science and Medicine Chapter 3: Bioinformatics and Computational Biology: Unraveling Biological Complexity Chapter 4: Bioprocessing and Biomanufacturing: Engineering the Future of Drug Production Chapter 5: Targeted Drug Delivery: Innovations in Nanotechnology and Drug Carriers Chapter 6: Biomarkers: The Key to Precision Diagnosis and Treatment Chapter 7: Regenerative Medicine: Harnessing the Power of Cellular and Tissue Engineering Chapter 8: Gene Editing and CRISPR Technology: Rewriting the Possibilities in Disease Treatment Chapter 9: Monoclonal Antibodies: Engineered Warriors against Disease Chapter 10: Unlocking the Genetic Code: Genomics and Personalized Medicine
Biologics And Biosimilars
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Author : Xiaodong Feng
language : en
Publisher: CRC Press
Release Date : 2022-06-13
Biologics And Biosimilars written by Xiaodong Feng and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2022-06-13 with Medical categories.
Biologics and Biosimilars: Drug Discovery and Clinical Applications is a systematic integration and evaluation of all aspects of biologics and biosimilars, encompassing research and development, clinical use, global regulation, and more. Biosimilars are biological therapeutic agents designed to imitate a reference biologic with high similarities in structure, efficacy, and safety, but also with potential clinical effective and cost-efficient options for the manufacturers, payers, clinicians, and patients. Most of the top-selling prescription drugs in the current market are biologics, which have revolutionized the treatment strategies and modalities for life-threatening and/or rare diseases. This book outlines the key processes and challenges in drug development, regulations, and clinical applications of biologics, biosimilars, and even interchangeable biosimilars. Global experts in the field discuss essential categories and prototype drugs of biologics and biosimilars in clinical practice such as allergenics, blood and blood components, cell treatment, gene therapy, recombinant therapeutic proteins or peptides, tissues, and vaccines. Additional features: Integrates the latest bench and bedside evidence of drug development and regulations of biologics and biosimilars Contains key study questions for each chapter to guide the readers, as well as drug charts for all therapeutic applications of biologics and biosimilars Presents detailed schematic illustrations to explain the drug development, clinical trials, regulations, and clinical applications of biologics and biosimilars This book is an invaluable tool for health care professional students, providers, and pharmaceutical and health care industries, as well as the public, providing readers with educational updates about the drug development and clinical affairs of biological medications and their similar drugs.
Pharmaceutical Inhalation Aerosol Technology Third Edition
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Author : Anthony J. Hickey
language : en
Publisher: CRC Press
Release Date : 2019-03-26
Pharmaceutical Inhalation Aerosol Technology Third Edition written by Anthony J. Hickey and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-03-26 with Medical categories.
This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors
Commerce Justice Science And Related Agencies Appropriations For 2011 Part 2 111 2 Hearings
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Author :
language : en
Publisher:
Release Date : 2010
Commerce Justice Science And Related Agencies Appropriations For 2011 Part 2 111 2 Hearings written by and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010 with categories.