Sarfaraz K. Niazi – författare

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:

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:

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:

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:

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.

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.

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.

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