Bioprocess And Analytics Development For Virus Based Advanced Therapeutics And Medicinal Products Atmps

Author : Saurabh Gautam,Abhilash I. Chiramel,Roland Pach
Publisher : Springer Nature
Page : 448 pages
File Size : 45,5 Mb
Release : 2023-08-10
Category : Medical
ISBN : 9783031284892

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Bioprocess and Analytics Development for Virus-based Advanced Therapeutics and Medicinal Products (ATMPs) by Saurabh Gautam,Abhilash I. Chiramel,Roland Pach Pdf

This book reviews the knowledge, methods and available techniques in the rapidly advancing field of virus based vaccines and gene therapeutics. It also highlights new innovative tools and interdisciplinary techniques for bioprocess development and analytics of viruses and viral vectors. As such, it provides a timely and highly relevant resource, since current advances in pharmaceutical research have seen the rise of vaccines and advanced therapeutics and medicinal products (ATMPs), that rely on the power of viruses. However, developing bioprocesses and analytics required to create this often called “magic bullet” (i.e. gene therapy) remains an extremely challenging and costly task. This book offers strategies for overcoming hurdles and difficulties within in all the necessary steps of viral vector development - from scalability to purification methods and quality control. The book is intended for researchers working in academia or industry, as well as graduate students pursuing a career in virology.

Author : Dilpreet Singh, Prashant Tiwari
Publisher : Bentham Science Publishers
Page : 339 pages
File Size : 54,5 Mb
Release : 2024-03-25
Category : Science
ISBN : 9789815223026

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9789815223026 by Dilpreet Singh, Prashant Tiwari Pdf

Software and Programming Tools in Pharmaceutical Research is a detailed primer on the use for computer programs in the design and development of new drugs. Chapters offer information about different programs and computational techniques in pharmacology. The book will help readers to harness computer technologies in pharmaceutical investigations. Readers will also appreciate the pivotal role that software applications and programming tools play in revolutionizing the pharmaceutical industry. The book includes nine structured chapters, each addressing a critical aspect of pharmaceutical research and software utilization. From an introduction to pharmaceutical informatics and computational chemistry to advanced topics like molecular modeling, data mining, and high-throughput screening, this book covers a wide range of topics. Key Features: · Practical Insights: Presents practical knowledge on how to effectively utilize software tools in pharmaceutical research. · Interdisciplinary Approach: Bridges the gap between pharmaceutical science and computer science · Cutting-Edge Topics: Covers the latest advancements in computational drug development, including data analysis and visualization techniques, drug repurposing, pharmacokinetic modelling and screening. · Recommendations for Tools: Includes informative tables for software tools · Referenced content: Includes scientific references for advanced readers The book is an ideal primer for students and educators in pharmaceutical science and computational biology, providing a comprehensive foundation for this rapidly evolving field. It is also an essential resource for pharmaceutical researchers, scientists, and professionals looking to enhance their understanding of software tools and programming in drug development.

Author : Dr Wojciech Chrzanowski,Professor Chwee Teck Lim,Dr Sally Yunsun Kim
Publisher : Royal Society of Chemistry
Page : 358 pages
File Size : 44,7 Mb
Release : 2021-10-29
Category : Technology & Engineering
ISBN : 9781788018944

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Extracellular Vesicles by Dr Wojciech Chrzanowski,Professor Chwee Teck Lim,Dr Sally Yunsun Kim Pdf

Extracellular and biofluids vesicles (EVs) are highly specialised yet ubiquitous nanoscale messengers secreted by cells. With the development of stem cell engineering, EVs promise to deliver next generation tools in regenerative medicine and tissue engineering, as well as in diagnostics. A vibrant and promising field, this book provides the first resource to the field. Covering basic cell biology, including EV production and intracellular communication, this book will provide material scientists and engineers with a foundation to the necessary biology. The reader will then learn about the isolation of extracellular vesicles their physicochemical characterisation and therapeutic application of EVs in regenerative medicine as well as their potential as biomarkers in medical diagnostic. This book will also discuss the regulatory landscape of EVs. Bridging cell biology, biomaterials, biophysics and biomedical engineering the content of this book is written with a broad interdisciplinary audience in mind. Researchers, new and established will find this a must-have on their shelf.

Author : Daan J. A. Crommelin,Robert D. Sindelar
Publisher : CRC Press
Page : 456 pages
File Size : 47,5 Mb
Release : 2002-11-14
Category : Medical
ISBN : 0415285011

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Pharmaceutical Biotechnology by Daan J. A. Crommelin,Robert D. Sindelar Pdf

The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well.

Author : Mohamed Al-Rubeai
Publisher : Springer Science & Business Media
Page : 259 pages
File Size : 47,9 Mb
Release : 2009-08-11
Category : Medical
ISBN : 9789048122455

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Cell Line Development by Mohamed Al-Rubeai Pdf

Mammalian cell lines command an effective monopoly for the production of therapeutic proteins that require post-translational modifications. This unique advantage outweighs the costs associated with mammalian cell culture, which are far grater in terms of development time and manufacturing when compared to microbial culture. The development of cell lines has undergone several advances over the years, essentially to meet the requirement to cut the time and costs associated with using such a complex hosts as production platforms. This book provides a comprehensive guide to the methodology involved in the development of cell lines and the cell engineering approach that can be employed to enhance productivity, improve cell function, glycosylation and secretion and control apoptosis. It presents an overall picture of the current topics central to expression engineering including such topics as epigenetics and the use of technologies to overcome positional dependent inactivation, the use of promoter and enhancer sequences for expression of various transgenes, site directed engineering of defined chromosomal sites, and examination of the role of eukaryotic nucleus as the controller of expression of genes that are introduced for production of a desired product. It includes a review of selection methods for high producers and an application developed by a major biopharmaceutical industry to expedite the cell line development process. The potential of cell engineering approch to enhance cell lines through the manipulation of single genes that play important roles in key metabolic and regulatory pathways is also explored throughout.

Author : Ralf Pörtner
Publisher : Humana
Page : 0 pages
File Size : 52,9 Mb
Release : 2016-08-23
Category : Science
ISBN : 149396318X

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Animal Cell Biotechnology by Ralf Pörtner Pdf

Animal Cell Biotechnology: Methods and Protocols, Third Edition constitutes a comprehensive manual of state-of-the-art and new techniques for setting up mammalian cell lines for production of biopharmaceuticals, and for optimizing critical parameters for cell culture from lab to final production. The volume is divided into five parts that reflect the processes required for different stages of production. In Part I, basic techniques for establishment of production cell lines are addressed, especially high-throughput synchronization, insect cell lines, transient gene and protein expression, DNA Profiling and Characterisation. Part II addresses tools for process and medium optimization as well as microcarrier technology while Part III covers monitoring of cell growth, viability and apoptosis, metabolic flux estimation, quenching methods as well as NMR-based techniques. Part IV details cultivation techniques, and Part V describes special applications, including vaccine production, baculovirus protein expression, chromatographic techniques for downstream as well as membrane techniques for virus separation. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Animal Cell Biotechnology: Methods and Protocols, Third Edition provides a compendium of techniques for scientists in industrial and research laboratories that use mammalian cells for biotechnology purposes.

Author : Reimund Neugebauer
Publisher : Springer Nature
Page : 404 pages
File Size : 43,9 Mb
Release : 2020-09-11
Category : Technology & Engineering
ISBN : 9783662596593

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Biological Transformation by Reimund Neugebauer Pdf

The global population is expected to rise to 9.8 billion by the year 2050 - with everyone ultimately striving for prosperity. New methods must therefore be found to achieve more efficient production. Research to date shows that the biological inventory that has evolved: its products, processes, principles and tools, can spur modern technology. The development of technological innovations based on biological concepts, with the goal of particularly innovative and sustainable value creation, today is collectively known as "biological transformation". It results in highly functional products with striking properties that can be both manufactured and utilized in a resource-saving way. In terms of taking responsibility of the good of all people, biological transformation is therefore a path that applied research will have to take. The Fraunhofer-Gesellschaft has recognized the developmental technology potential of biological transformation and sees it as its task not only to drive the relevant research forward, but also to promote public awareness of the topic.

Author : Joaquim M. S. Cabral,Cláudia Lobato da Silva,Maria Margarida Diogo
Publisher : MDPI
Page : 170 pages
File Size : 55,7 Mb
Release : 2021-01-20
Category : Science
ISBN : 9783039430383

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Stem Cell Bioprocessing and Manufacturing by Joaquim M. S. Cabral,Cláudia Lobato da Silva,Maria Margarida Diogo Pdf

The next healthcare revolution will apply regenerative medicines using human cells and tissues. The aim of the regenerative medicine approach is to create biological therapies or substitutes in vitro for the replacement or restoration of tissue function in vivo lost through failure or disease. However, whilst science has revealed the potential, and early products have shown the power of such therapies, there is an immediate and long-term need for expertise with the necessary skills to face the engineering and life science challenges before the predicted benefits in human healthcare can be realized. Specifically, there is a need for the development of bioprocess technology for the successful transfer of laboratory-based practice of stem cell and tissue culture to the clinic as therapeutics through the application of engineering principles and practices. This Special Issue of Bioengineering on Stem Cell Bioprocessing and Manufacturing addresses the central role in defining the engineering sciences of cell-based therapies, by bringing together contributions from worldwide experts on stem cell biology and engineering, bioreactor design and bioprocess development, scale-up, and manufacturing of stem cell-based therapies.

Author : Ângela Sousa
Publisher : Humana
Page : 335 pages
File Size : 46,9 Mb
Release : 2021-09-05
Category : Medical
ISBN : 1071608746

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DNA Vaccines by Ângela Sousa Pdf

This volume details practical procedures on the latest DNA vaccine technology. Chapters guide readers through methods and protocols on DNA vaccine design, the adjuvant influence, production and purification methodologies, delivery systems, and approaches of the influence of DNA vaccines in the immunological response performance and in the cancer immunotherapy. Written in the highly successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and cutting-edge, DNA Vaccines: Methods and Protocols aims to ensure successful results in the further study of this vital field.

Author : Ispe
Publisher : Unknown
Page : 176 pages
File Size : 45,8 Mb
Release : 2018-11-30
Category : Electronic
ISBN : 1946964123

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ISPE Good Practice Guide by Ispe Pdf

Author : Regine Eibl,Dieter Eibl,Ralf Pörtner,Gerardo Catapano,Peter Czermak
Publisher : Springer Science & Business Media
Page : 367 pages
File Size : 49,5 Mb
Release : 2008-09-30
Category : Science
ISBN : 9783540681823

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Cell and Tissue Reaction Engineering by Regine Eibl,Dieter Eibl,Ralf Pörtner,Gerardo Catapano,Peter Czermak Pdf

The completion of the Human Genome Project and the rapid progress in cell bi- ogy and biochemical engineering, are major forces driving the steady increase of approved biotech products, especially biopharmaceuticals, in the market. Today mammalian cell products (“products from cells”), primarily monoclonals, cytokines, recombinant glycoproteins, and, increasingly, vaccines, dominate the biopharmaceutical industry. Moreover, a small number of products consisting of in vitro cultivated cells (“cells as product”) for regenerative medicine have also been introduced in the market. Their efficient production requires comprehensive knowledge of biological as well as biochemical mammalian cell culture fundamentals (e.g., cell characteristics and metabolism, cell line establishment, culture medium optimization) and related engineering principles (e.g., bioreactor design, process scale-up and optimization). In addition, new developments focusing on cell line development, animal-free c- ture media, disposables and the implications of changing processes (multi-purpo- facilities) have to be taken into account. While a number of excellent books treating the basic methods and applications of mammalian cell culture technology have been published, only little attention has been afforded to their engineering aspects. The aim of this book is to make a contribution to closing this gap; it particularly focuses on the interactions between biological and biochemical and engineering principles in processes derived from cell cultures. It is not intended to give a c- prehensive overview of the literature. This has been done extensively elsewhere.

Author : Hanns-Christian Mahler,Wim Jiskoot
Publisher : John Wiley & Sons
Page : 480 pages
File Size : 42,6 Mb
Release : 2012-01-24
Category : Medical
ISBN : 9780470497180

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Analysis of Aggregates and Particles in Protein Pharmaceuticals by Hanns-Christian Mahler,Wim Jiskoot Pdf

This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.

Author : Damian J. Houde,Steven A. Berkowitz
Publisher : Elsevier
Page : 586 pages
File Size : 45,9 Mb
Release : 2019-11-13
Category : Medical
ISBN : 9780444641748

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals by Damian J. Houde,Steven A. Berkowitz Pdf

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

Author : Roland W. Herzog
Publisher : Wiley-Blackwell
Page : 0 pages
File Size : 44,9 Mb
Release : 2008-12-03
Category : Medical
ISBN : 0470134062

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Gene Therapy Immunology by Roland W. Herzog Pdf

Summarises and reviews the important field of genetic therapy with respect to the latest immunological advances in the lab and clinic Unique treatment of immunology and immunotherapy in gene - approached from a vector and target organ point of view rather than from the perspective a specific diseases Broad appeal - applicable for immunology and genetics / gene therapy, recombinant DNA studies, transplantation, virology, cancer research and tumor research

Author : Nicholas W. Warne,Hanns-Christian Mahler
Publisher : Springer
Page : 599 pages
File Size : 54,5 Mb
Release : 2018-06-20
Category : Medical
ISBN : 9783319906034

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Challenges in Protein Product Development by Nicholas W. Warne,Hanns-Christian Mahler Pdf

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.