Download or read book Techniques for Downstream process for Biologic Drugs and Vaccines written by Basanta Kumara Behera and published by Elsevier. This book was released on 2023-08-01 with total page 280 pages. Available in PDF, EPUB and Kindle. Book excerpt: Techniques for Downstream process for Biologic Drugs and Vaccines provides comprehensive technologies involved in processing postharvest broth to separate the target biological therapeutic products of extracellular or intercellular aspects in nature - to its highest purification form, and to thus make it acceptable to end users. The technologies involved in the post-harvesting of fermented broth are explained in this comprehensive resource in a simplified manner with different case studies to help non-engineering students and scientists easily capture the basic principle of biomass processing technologies and their applications in new projects related to the development and manufacturing of therapeutic bio-products. As conceptual development of biotechnology has taken new shape and style with the integration of medical sciences, physical science, and engineering, and has thus begun the need for the development of microbial or cell line process technology and application for large-scale isolation and purification of metabolites or vaccines through the fermentation process, this book covers the most important aspects. - Provides insights into the conceptual strategic drive for manufacturing innovative biologically derived therapeutic compounds for commercial purposes - Focuses on how to execute biopharmaceutical portfolio trends to bring sustainable manufacturing process as per guidelines of international regulatory acts - Highlights emerging trends in medical sciences on tissue engineering, regenerative medicine, personalized medicines, and various innovative techniques on immunotherapy to fight against life-threatening diseases

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 The Anthrax Vaccine written by Institute of Medicine and published by National Academies Press. This book was released on 2002-04-18 with total page 288 pages. Available in PDF, EPUB and Kindle. Book excerpt: The vaccine used to protect humans against the anthrax disease, called Anthrax Vaccine Adsorbed (AVA), was licensed in 1970. It was initially used to protect people who might be exposed to anthrax where they worked, such as veterinarians and textile plant workers who process animal hair. When the U. S. military began to administer the vaccine, then extended a plan for the mandatory vaccination of all U. S. service members, some raised concerns about the safety and efficacy of AVA and the manufacture of the vaccine. In response to these and other concerns, Congress directed the Department of Defense to support an independent examination of AVA. The Anthrax Vaccine: Is It Safe? Does It Work? reports the study's conclusion that the vaccine is acceptably safe and effective in protecting humans against anthrax. The book also includes a description of advances needed in main areas: improving the way the vaccine is now used, expanding surveillance efforts to detect side effects from its use, and developing a better vaccine.

Download or read book Biochemical Engineering and Biotechnology written by Ghasem Najafpour and published by Elsevier. This book was released on 2015-02-24 with total page 669 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biochemical Engineering and Biotechnology, 2nd Edition, outlines the principles of biochemical processes and explains their use in the manufacturing of every day products. The author uses a diirect approach that should be very useful for students in following the concepts and practical applications. This book is unique in having many solved problems, case studies, examples and demonstrations of detailed experiments, with simple design equations and required calculations. - Covers major concepts of biochemical engineering and biotechnology, including applications in bioprocesses, fermentation technologies, enzymatic processes, and membrane separations, amongst others - Accessible to chemical engineering students who need to both learn, and apply, biological knowledge in engineering principals - Includes solved problems, examples, and demonstrations of detailed experiments with simple design equations and all required calculations - Offers many graphs that present actual experimental data, figures, and tables, along with explanations

Download or read book Conceptual Development of Industrial Biotechnology for Commercial Production of Vaccines and Biopharmaceuticals written by Basanta Kumara Behera and published by Elsevier. This book was released on 2023-03-07 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: Conceptual Development of Industrial Biotechnology for Commercial Production of Biopharmaceuticals and Vaccines provides insights on how to bring sustainability into biologic drug production. The cumulative facts and figures within in the book are helpful to promoters in monitoring value chain transfer process of super quality biologics for better return in profits. In addition, this is a useful reference for students, researchers and scientists in biotechnology, pharmaceutical science, medical sciences, and the R&D division of biotechnology-based industries. Conceptual development of biotechnology has taken new avenues with the integration of medical sciences, physical science, and engineering, hence this is a timely source. The current global market for vaccines, especially COVID-19, is tremendous. Bivalent oral polio vaccine, diphtheria, tetanus-containing, and measles-containing vaccines have a high demand internationally and recombinant DNA technology and protein engineering are helpful in the production of quality bio-products. - Informs how biotechnology and pharmaceutical industries act as central pillars for the stable production of value-added biological drugs and vaccines from genetically engineered suitable vectors like microbe or cell lines from animals, mammals or plants - Highlights various traditional and modern techniques used for improvising the quality of suitable vectors to produce biologic drugs and vaccines under GMP manufacturing facilities - Provides updated information on the latest microchip-based bioreactors, disposable bag bioreactors, and animal systems as bioreactors to produce biologic drugs like Smart Biomolecules (next generation therapeutics), Bio-similar drugs, Bio-betters, and antibody-drug conjugates - Explains how the closed bioreactors with proper mechanical amendments are used for vaccine production

Download or read book FDA Biotechnology Inspection Guide written by United States. Food and Drug Administration and published by . This book was released on 1991 with total page 62 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Download or read book Registries for Evaluating Patient Outcomes written by Agency for Healthcare Research and Quality/AHRQ and published by Government Printing Office. This book was released on 2014-04-01 with total page 385 pages. Available in PDF, EPUB and Kindle. Book excerpt: This User’s Guide is intended to support the design, implementation, analysis, interpretation, and quality evaluation of registries created to increase understanding of patient outcomes. For the purposes of this guide, a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves one or more predetermined scientific, clinical, or policy purposes. A registry database is a file (or files) derived from the registry. Although registries can serve many purposes, this guide focuses on registries created for one or more of the following purposes: to describe the natural history of disease, to determine clinical effectiveness or cost-effectiveness of health care products and services, to measure or monitor safety and harm, and/or to measure quality of care. Registries are classified according to how their populations are defined. For example, product registries include patients who have been exposed to biopharmaceutical products or medical devices. Health services registries consist of patients who have had a common procedure, clinical encounter, or hospitalization. Disease or condition registries are defined by patients having the same diagnosis, such as cystic fibrosis or heart failure. The User’s Guide was created by researchers affiliated with AHRQ’s Effective Health Care Program, particularly those who participated in AHRQ’s DEcIDE (Developing Evidence to Inform Decisions About Effectiveness) program. Chapters were subject to multiple internal and external independent reviews.

Download or read book Tools Techniques of Plant Molecular Farming written by Chittaranjan Kole and published by Springer Nature. This book was released on 2023-11-22 with total page 422 pages. Available in PDF, EPUB and Kindle. Book excerpt: This edited book is an in-depth compilation of recent tools and techniques, concepts and strategies used globally in plant molecular farming (PMF) for the cost-effective bulk production of recombinant proteins, secondary metabolites, and other biomolecules. The book presents an overview of success stories of PMF applications from developing countries to address poverty, achieve zero hunger, good health and well-being, thus achieving the UN SDGs 1, 2, and 3. The book deep dives into recent extraction and downstream processing methodologies, its co-existence with conventional agriculture, global governance and finally opportunities, challenges, and future perspectives in plant molecular farming. It focuses on plastid/chloroplast transformation (transplastomics) and its application in plant molecular farming. The books highlight recent advances in genome editing, synthetic biology, glycosylation and glyco-engineering for improved plant molecular farming by marker-free and tissue-specific systems via cisgenic and transgenic crops. In depth discussions on biosafety issues and bio-containment strategies have also been included. The book has 15 chapters authored by globally leading experts on the subject, presenting opportunities & challenges for bio-industrial researchers and entrepreneurs. It is useful to researchers, industrialists, entrepreneurs, policy planners, academician, and students across the disciplines.

Download or read book The Challenge of CMC Regulatory Compliance for Biopharmaceuticals written by John Geigert and published by Springer. This book was released on 2019-05-08 with total page 446 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.

Download or read book The Role of NIH in Drug Development Innovation and Its Impact on Patient Access written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2020-01-27 with total page 103 pages. Available in PDF, EPUB and Kindle. Book excerpt: To explore the role of the National Institutes of Health (NIH) in innovative drug development and its impact on patient access, the Board on Health Care Services and the Board on Health Sciences Policy of the National Academies jointly hosted a public workshop on July 24â€"25, 2019, in Washington, DC. Workshop speakers and participants discussed the ways in which federal investments in biomedical research are translated into innovative therapies and considered approaches to ensure that the public has affordable access to the resulting new drugs. This publication summarizes the presentations and discussions from the workshop.

Download or read book Advanced Biologic Drugs and Manufacturing Process written by Basanta Kumara Behera and published by Elsevier. This book was released on 2024-05-10 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

Download or read book Handbook of Process Chromatography written by Gunter Jagschies and published by Elsevier. This book was released on 2007-12-08 with total page 383 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book will update the original edition published in 1997. Since the publication of the first edition, the biotechnology and biologics industries have gained extensive knowledge and experience in downstream processing using chromatography and other technologies associated with recovery and purification unit operations. This book will tie that experience together for the next generation of readers.Updates include:- sources and productivity- types of products made today- experiences in clinical and licensed products - economics- current status of validation- illustrations and tables- automated column packing- automated systemsNew topics include:- the use of disposables- multiproduct versus dedicated production- design principles for chromatography media and filters- ultrafiltration principles and optimization- risk assessments- characterization studies- design space- platform technologies- process analytical technologies (PATs)- biogenerics - comparability assessmentsKey Features:- new approaches to process optimiaztion- use of patform technologies- applying risk assessment to process design

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 Three Phase Partitioning written by Munishwar Nath Gupta and published by Elsevier. This book was released on 2021-08-11 with total page 346 pages. Available in PDF, EPUB and Kindle. Book excerpt: Three Phase Partitioning: Applications in Separation and Purification of Biological Molecules and Natural Products presents applications in diverse areas of both chemical technology and biotechnology. This book serves as a single resource for learning about both the economical, facile and scalable processes, along with their potential for applications in the separation and purification of materials and compounds across the entire spectra of chemical and biological nature. The book begins by explaining the origins and fundamentals of TPP and continues with chapters on related applications, ranging from the purification of parasite recombinant proteases to oil extraction from oilseeds and oleaginous microbes, and more. - Written by researchers who have been pioneers in developing and utilizing three phase partitioning - Focuses on applications, with chapters detailing relevance to a wide variety of areas and numerous practical examples - Designed to give laboratory workers the information needed to undertake the challenge of designing successful three-phase partitioning protocols

Download or read book Biologics Biosimilars and Biobetters written by Iqbal Ramzan and published by John Wiley & Sons. This book was released on 2021-02-03 with total page 328 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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

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 367 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 Biopharmaceuticals written by Ming-Kung Yeh and published by BoD – Books on Demand. This book was released on 2018-09-19 with total page 140 pages. Available in PDF, EPUB and Kindle. Book excerpt: Biopharmaceuticals are derived from biological sources, either live organisms or their active components; nowadays, they are mainly produced by biotechnologies. Biopharmaceuticals are extensively used in the treatment of various diseases such as cardiovascular, metabolic, neurological diseases, cancer, and others for which there are no available therapeutic methods. With the advance of science, biopharmaceuticals have revolutionized the treatment, prevention, and diagnosis of many patients with disabling and life-threatening diseases. Innovative biopharmaceuticals definitely improve the life quality of patients and enhance the effectiveness of the healthcare system. This book encompasses the discovery, production, application, and regulation of biopharmaceuticals to demonstrate their research achievement, prospects, and challenges. We expect the significance of biopharmaceuticals to be revealed and emphasized by this book.