1 870 kr
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1 870 kr
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1 923 kr
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7 671 kr
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1 928 kr
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This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the regulatory processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product for commercial distribution, including areas of current GMP, registration, and legal and ethical considerations. Emerging trends in the technology and regulatory compliance are also discussed, with advice on establishing efficient manufacturing facilities. Intended for practitioners in the commercial biopharmaceutical manufacturing industry, the text is an ideal resource for practitioners looking to develop their ability to manufacture biopharmaceutical products at a large scale.
Key Features:
Covers the essential aspects of commercial biopharmaceutical manufacturing for industry practitioners, including the planning, layout and operationProvides sufficient information for industry practitioners to establish and operate GMP (Good Manufacturing Practice) compliant manufacturing operationsIncludes case studies and step-by-step procedures for manufacturing specific biopharmaceutical productsFocused exclusively on products intended for human useIncludes coverage of regulatory requirements, intellectual property challenges, training of manufacturing teams and issues around cost optimisation413 kr
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1 908 kr
Skickas inom 5-8 vardagar
This two-volume set provides a comprehensive guide to the essential aspects of commercial biopharmaceutical manufacturing. Covering the planning, layout and operation of successful commercial manufacturing, the aim of the books is to enable innovations, new drug development, and make affordable biological drugs available to patients worldwide. This volume covers the unit processes involved in producing a GMP (Good Manufacturing Practice) biopharmaceutical product, laid out in the order of operation, with complete details on equipment, compliance and yield improvement suggestions. The unit processes described include several emerging trends and advice on reducing the costs of the product and efficient scale up techniques. Intended for practitioners in the commercial biopharmaceutical manufacturing industry, the text is an ideal resource for practitioners looking to develop their ability to manufacture biopharmaceutical products at a large scale.
Key Features:
Covers the essential aspects of commercial biopharmaceutical manufacturing for industry practitioners, including the planning, layout and operationProvides sufficient information for industry practitioners to establish and operate GMP (Good Manufacturing Practice) compliant manufacturing operationsIncludes case studies and step-by-step procedures for manufacturing specific biopharmaceutical productsFocused exclusively on products intended for human useIncludes coverage of regulatory requirements, intellectual property challenges, training of manufacturing teams and issues around cost optimisation413 kr
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1 815 kr
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Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future.
Key Features:
Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.1 815 kr
Läs direkt efter köp
Before now, biological systems could only be expressed in terms of linear relationships, however, as knowledge grows and new techniques of analysis on biological systems is made available, we are realizing the non-linearity of these systems. The concepts and techniques of nonlinear analysis allow for more realistic and accurate models in science. The Future of Pharmaceuticals: A Nonlinear Analysis provides an opportunity to understand the non-linearity of biological systems and its application in various areas of science, primarily pharmaceutical sciences. This book will benefit professionals in pharmaceutical industries, academia, and policy who are interested in an entirely new approach to how we will treat disease in the future.
Key Features:
Addresses a new approach of nonlinear analysis. Applies a theory of projection to chalk out the future, instead of basing on linear evolution. Provides an opportunity to better understand the non-linearity in biological systems and its applications in various areas of science, primarily pharmaceutical sciences. Helps change the thought process for those looking for answers to their questions which they do not find in the linear relationship approach. Encourages a broader perspective for the creative process of drug development.881 kr
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This book is the most comprehensive and complete treatise on nucleic acid therapeuticproducts, including mRNA vaccines, their manufacturing, formulations, andtesting for safety and efficacy. Details include cGMP-compliant manufacturing andregulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presentedto secure fast approval of copies of mRNA vaccines. Projections of financial plansto establish RNA manufacturing facilities are provided, along with details of supplychain management. Finally, the future of nucleic acid products in gene therapy andother newer applications is presented, along with a perspective that all new vaccineswill be the nucleic acid type that will further provide first-time prevention of autoimmunedisorders. It is projected that both big pharma and start-ups will enter this field,and we can expect significant additions to our drug armamentarium soon.
881 kr
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This book is the most comprehensive and complete treatise on nucleic acid therapeuticproducts, including mRNA vaccines, their manufacturing, formulations, andtesting for safety and efficacy. Details include cGMP-compliant manufacturing andregulatory filing steps. A new concept of “biosimilar” mRNA vaccine is presentedto secure fast approval of copies of mRNA vaccines. Projections of financial plansto establish RNA manufacturing facilities are provided, along with details of supplychain management. Finally, the future of nucleic acid products in gene therapy andother newer applications is presented, along with a perspective that all new vaccineswill be the nucleic acid type that will further provide first-time prevention of autoimmunedisorders. It is projected that both big pharma and start-ups will enter this field,and we can expect significant additions to our drug armamentarium soon.
2 468 kr
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939 kr
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873 kr
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After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author''s hands-on experience.
Features:
Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe. Provides a better understanding of the safety and efficacy of approved biosimilars. Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here. Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis. Renowned author and entrepreneur in the field of drug discovery and production.873 kr
Läs direkt efter köp
After 18 years since the first biosimilar was approved, a lot has changed, from the regulatory guidelines to the stakeholder perceptions about the safety and efficacy of biosimilars. However, the development costs remain high, preventing faster entry into markets with more than 200 choices. Analyzing the regulatory filings of all approved biosimilars in the US and EU, a deep analysis of the scientific principles, and continuous challenges to the regulatory authorities have made it possible to plan the development on a fast track. This book teaches how to cut the current time and cost by more than 70%, based on the author''s hands-on experience.
Features:
Describes the emergence of biosimilars since the first publication of the recombinant engineering patent, as well as a listing of all approved recombinant products, their patent expiry and their adoption across the globe. Provides a better understanding of the safety and efficacy of approved biosimilars. Global approval requires accommodating guidelines and detailed planning to avoid redundancy as well as high costs. The basic expectations of the agencies are presented here. Presents a detailed analysis of all EU and FDA-approved products with a comparative analysis. Renowned author and entrepreneur in the field of drug discovery and production.