Plasmid Biopharmaceuticals PDF Download

Author: Duarte Miguel F. Prazeres
Publisher: John Wiley & Sons
ISBN: 1118002253
Category : Medical
Languages : en
Pages : 465

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Book Description
The book addresses the basics, applications, and manufacturing of plasmid biopharmaceuticals. The survey of the most relevant characteristics of plasmids provides the basics for designing plasmid products (applications) and processes (manufacturing). Key features that the authors include in the book are: i) consistency and clear line of direction, ii) an extensive use of cross-referencing between the individual chapters, iii) a rational integration of chapters, iv) appellative figures, tables and schemes, and v) an updated, but selected choice of references, with a focus on key papers.

Author: Marcelo E. Tolmasky
Publisher: John Wiley & Sons
ISBN: 1555818986
Category : Science
Languages : en
Pages : 720

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Book Description
Explore the remarkable discoveries in the rapidly expanding field of plasmid biology Plasmids are integral to biological research as models for innumerable mechanisms of living cells, as tools for creating the most diverse therapies, and as crucial helpers for understanding the dissemination of microbial populations. Their role in virulence and antibiotic resistance, together with the generalization of "omics" disciplines, has recently ignited a new wave of interest in plasmids. This comprehensive book contains a series of expertly written chapters focused on plasmid biology, mechanistic details of plasmid function, and the increased utilization of plasmids in biotechnology and pharmacology that has occurred in the past decade. Plasmids: Biology and Impact in Biotechnology and Discovery serves as an invaluable reference for researchers in the wide range of fields and disciplines that utilize plasmids and can also be used as a textbook for upper-level undergraduate and graduate courses in biotechnology and molecular biology.

Author: John Geigert
Publisher: Springer Nature
ISBN: 3031319095
Category : Science
Languages : en
Pages : 597

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Book Description
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.

Author: Bo Mattiasson
Publisher: CRC Press
ISBN: 1420084623
Category : Medical
Languages : en
Pages : 514

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Book Description
Macroporous polymers are rapidly becoming the material of choice for many tissue engineering, bioseparation, and bioprocessing applications. However, while important information is scattered about in many different publications, none, to date, have drawn this information together in user-friendly format, until now. Meeting the need for an accessibl

Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527653112
Category : Medical
Languages : en
Pages : 945

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Book Description
Cost-effective manufacturing of biopharmaceutical products is rapidly gaining in importance, while healthcare systems across the globe are looking to contain costs and improve efficiency. To adapt to these changes, industries need to review and streamline their manufacturing processes. This two volume handbook systematically addresses the key steps and challenges in the production process and provides valuable information for medium to large scale producers of biopharmaceuticals. It is divided into seven major parts: - Upstream Technologies - Protein Recovery - Advances in Process Development - Analytical Technologies - Quality Control - Process Design and Management - Changing Face of Processing With contributions by around 40 experts from academia as well as small and large biopharmaceutical companies, this unique handbook is full of first-hand knowledge on how to produce biopharmaceuticals in a cost-effective and quality-controlled manner.

Author: G. Walsh
Publisher: Springer Science & Business Media
ISBN: 9780792357469
Category : Medical
Languages : en
Pages : 532

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Book Description
This book provides a unique and up-to-date insight into the biopharmaceutical industry. Largely written by industrial authors, its scope is multidisciplinary, rendering it an ideal reference source for students undertaking advanced undergraduate or postgraduate courses in biotechnology, pharmaceutical science, biochemistry, or medicine.

Author: Jörg Knäblein
Publisher: John Wiley & Sons
ISBN: 352731184X
Category : Science
Languages : en
Pages : 2074

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Book Description
The biopharmaceutical market has come along way since 1982 when the first biopharmaceutical product, recombinant human insulin, was launched. Over 120 such products are currently being marketed around the world including nine blockbuster drugs. The global market for biopharmaceuticals, which is currently valued at US$41 billion, has been growing at an impressive compound annual growth rate of 21% over the previous five years. With over one third of all pipe-line products in active development are biopharmaceuticals, this segment is set to continue outperforming the total pharmaceutical market and could easily reach US$100 billion by the end of this decade.

Author: Gary Walsh
Publisher: John Wiley & Sons
ISBN: 1118687388
Category : Medical
Languages : en
Pages : 544

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Book Description
The latest edition of this highly acclaimed textbook, provides a comprehensive and up-to-date overview of the science and medical applications of biopharmaceutical products. Biopharmaceuticals refers to pharmaceutical substances derived from biological sources, and increasingly, it is synonymous with 'newer' pharmaceutical substances derived from genetic engineering or hybridoma technology. This superbly written review of the important areas of investigation in the field, covers drug production, plus the biochemical and molecular mechanisms of action together with the biotechnology of major biopharmaceutical types on the market or currently under development. There is also additional material reflecting both the technical advances in the area and detailed information on key topics such as the influence of genomics on drug discovery.

Author: Anurag Singh Rathore
Publisher: CRC Press
ISBN: 1003805469
Category : Medical
Languages : en
Pages : 413

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Book Description
The fourth edition of Process Validation in Manufacturing of Biopharmaceuticals is a practical and comprehensive resource illustrating the different approaches for successful validation of biopharmaceutical processes. A pivotal text in its field, this new edition provides guidelines and current practices, contains industrial case studies, and is expanded to include in-depth analysis of the new Process Validation (PV) guidance from the US FDA. Key Features: Offers readers a thorough understanding of the key concepts that form the basis of a good process validation program for biopharmaceuticals. Includes case studies from the various industry leaders that demonstrate application of these concepts. Discusses the use of modern tools such as multivariate analysis for facilitating a process validation exercise. Covers process characterization techniques for scaling down unit operations in biopharmaceutical manufacturing, including chromatography, chemical modification reactions, ultrafiltration, and microfiltration, and practical methods to test raw materials and in-process samples. Providing a thorough understanding of the key concepts that form the basis of a good process validation program, this book will help readers ensure that PV is carried out and exceeds expectations. Fully illustrated, this is a much-needed practical guide for biopharmaceutical manufacturers.

Author: José das Neves
Publisher: Springer Science & Business Media
ISBN: 1461495245
Category : Medical
Languages : en
Pages : 603

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Book Description
Biopharmaceutical medicines, the newest class of therapeutics, are quite heterogeneous and include a range of molecules such as proteins, peptides, vaccines and nucleic acids, with use in virtually all therapeutic fields (e.g. cancer and infectious diseases, vaccination, metabolic dysfunctions) and diagnostics. This edited book gives a concise and up-to-date overview of the biological features justifying the use of different human mucosa as delivery routes for biopharmaceuticals, the technological strategies that have been followed so far regarding the optimization of mucosal potentialities as well as the challenges that arise with the advent of new biopharmaceutical drugs and alternative means of administration. Following a brief introduction, the first section addresses general aspects of the biology of mucosal tissues and their unique aspects toward beneficial or deleterious interaction with biopharmaceuticals and their delivery systems. The second part reviews the different delivery strategies that have recently been investigated for different mucosal sites. The third section describes the development and clinical applications of drug delivery systems and products enclosing biopharmaceuticals for mucosal delivery, with a focus on the most successful case studies of recent years. The last section briefly centers on relevant aspects of the regulatory, toxicological and market issues of mucosal delivery of biopharmaceuticals.​ Scientists and researchers in the fields of drug delivery, material science, biomedical science and bioengineering as well as professionals, regulators and policy makers in the pharmaceutical, biotechnology and healthcare industries will find in this book an important compendium of fundamental concepts and practical tools for their daily research and activities.