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

Tailoring of biomolecules using protein engineering technology, and host cells culture techniques are among the most sophisticated and elegant achievements of modern applied life sciences in which the basic fundamentals biotechnology are applicable for the development and manufacturing of biologics and other related bio-molecules for a hurdle free life with good health. A majority of biologics derived from genetically modified host cells in the current market are bio-formulation such as antibodies, nucleic acid products and vaccines. Such bio-formulations are developed mainly in two steps i.e. upstream process and downstream process. The first volume of this series begins with the latest information on how the classical stepwise host cells culture (mammals, animals, plants, and bacteria) methodology has been changed to fully continuous or partially continuous host cells culture process in order to economise the biopharmaceutical products manufacturing process. In addition this volume narrates a brief history on conceptual development of new thoughts in designing biotechnology industries for commercial production of variety of therapeutic proteins with structural modification on the basis of clinical requirements. The readers will feel exited by going through the latest discovery and development in applied life sciences for designing innovative biomolecules for health care with utmost safe. The most interesting part of this volume is newly developed concept on bioprinting. It explains how to design and fabricate animate objects by fusing or depositing material of interest in the form of powders, solid dusts, metal, liquid or even living cells or tissues by layers to produce 3D objectives. The first volume ends with the latest information on the current trend in biologics market, market dynamic, drives, and opportunities with challenges.

Industrial biotechnology can be defined as the use of modern biological life sciences in process of industries. For example, industrial biotechnology has applications in a number of markets that affect our daily lives: in chemicals; in food processing; and in textiles just to name a few. Additionally, industrial biotechnology may not only help with better processing of materials, but it may also play an important role on reducing emissions and increasing efficiencies in the manufacturing process. Industrial biotechnology is transforming many of the world s industrial operations. The promise of industrial biotechnology has always been to reduce or replace the use of fossil energy and hydrocarbon-based materials with renewable, plant-based resources and naturally occurring microbes to produce more cost-effective and environmental-friendly materials for textiles, fuels, chemicals, pollution prevention and even human pharmaceuticals. Designed for students and practitioners of biotechnology and related fields, this book describes the potential applications of biotechnology in the industrial sector. This unique and up-to-date resource offering readers an innovative and valuable presentation of the subject.

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.

The ability of the United States to sustain a dominant global position in biotechnology lies in maintaining its primacy in basic life-science research and developing a strong resource base for bioprocess engineering and bioproduct manufacturing. This book examines the status of bioprocessing and biotechnology in the United States; current bioprocess technology, products, and opportunities; and challenges of the future and what must be done to meet those challenges. It gives recommendations for action to provide suitable incentives to establish a national program in bioprocess-engineering research, development, education, and technology transfer.

Animal biotechnology is a broad field including polarities of fundamental and applied research, as well as DNA science, covering key topics of DNA studies and its recent applications. In Introduction to Pharmaceutical Biotechnology, DNA isolation procedures followed by molecular markers and screening methods of the genomic library are explained in detail. Interesting areas such as isolation, sequencing and synthesis of genes, with broader coverage of the latter, are also described. The book begins with an introduction to biotechnology and its main branches, explaining both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It then moves on to the historical development and scope of biotechnology with an overall review of early applications that scientists employed long before the field was defined. Additionally, this book offers first-hand accounts of the use of biotechnology tools in the area of genetic engineering and provides comprehensive information related to current developments in the following parameters: plasmids, basic techniques used in gene transfer, and basic principles used in transgenesis. The text also provides the fundamental understanding of stem cell and gene therapy, and offers a short description of current information on these topics as well as their clinical associations and related therapeutic options.

This book reviews the assessment of industrial biotechnology products and processes from a sustainable perspective. Industrial Biotechnology is a comparably young field which comes along with high expectations with regard to sustainability issues. These stem from the promise of reducing greenhouse gas emissions and replacing fossil resources in the near or later future and using green technology, i.e. more environmentally friendly technologies. The intended economic, ecological and social benefits, however, need to be proven, resulting in a variety of challenges, both from a methodological and application point of view. In this book, specific assessment and application topics of industrial biotechnology are addressed, highlighting challenges and solutions for both developers and users of assessment methods. In twelve chapters, experts in their particular fields define the scope, characterize industrial biotechnology and show in their contributions the state of the art, challenges and prospects of assessing industrial biotechnology products and processes. The chapter 'Societal and Ethical Aspects of Industrial Biotechnology' of this book is available open access under a CC BY 4.0 license at link.springer.com