Challenges In Protein Product Development
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Challenges In Protein Product Development
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Author : Nicholas W. Warne
language : en
Publisher: Springer
Release Date : 2018-06-20
Challenges In Protein Product Development written by Nicholas W. Warne and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-20 with Medical categories.
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.
Principles And Practices Of Lyophilization In Product Development And Manufacturing
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Author : Feroz Jameel
language : en
Publisher: Springer Nature
Release Date : 2023-04-24
Principles And Practices Of Lyophilization In Product Development And Manufacturing written by Feroz Jameel and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-04-24 with Medical categories.
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T cell engager ( BITES), Dual Variable Domain ( DVD), Chimeric Antigen Receptor - Modified Tcells (CART) that are currently being used as therapeutic agents for immunology and oncology disease conditions. In addition to other pharmaceuticals and biopharmaceuticals, all these novel formats are fragile with respect to their stability/structure under processing conditions meaning marginal stability in the liquid state and often require lyophilization to enhance their stability and shelf-life. This book contains chapters/topics that will describe every aspect of the lyophilization process and product development and manufacturing starting from the overview of lyophilization process, equipment required, characterization of the material, design and development of the formulation and lyophilization process, various techniques for characterization of the product, scale-up/tech-transfer and validation. It also describes the application of CFD coupled with mathematical modeling in the lyophilization process and product development, scale-up, and manufacturing. Additionally, Principles and Practice of Lyophilization Process and Product Development contains an entire dedicated section on “Preservation of Biologicals” comprised of nine chapters written by experts and including case studies.
Challenges And Potential Solutions In Gluten Free Product Development
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Author : Navneet Singh Deora
language : en
Publisher: Springer Nature
Release Date : 2021-12-04
Challenges And Potential Solutions In Gluten Free Product Development written by Navneet Singh Deora and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021-12-04 with Technology & Engineering categories.
This work provides researchers with a thorough overview of all aspects related to the development of gluten-free food products. In summarizing and offering critical reviews of published works and focusing on current advances and technologies in gluten free product development, this book covers all of the important subjects related to this increasingly important aspect of the food industry. Important case studies in gluten-free breadmaking and alternative proteins are presented, making this a rich and singular source for food manufacturers and scientists seeking practical knowledge on the challenges and solutions involved in the development of gluten-free foods. Challenges and Potential Solutions in Gluten Free Product Development covers the latest advances and strategies for gluten-free diets including the important nutritional factors involved. Traditional and alternative approaches for the development of gluten-free dough, including starch applications and microbial fermentations, are extensively covered. Alternative proteins including those from vegetables, cereals, legumes and eggs are presented. Novel approaches for gluten-free breadmaking such as aeration strategies, prebiotics, hydrocolloids and nutritional enhancements are also covered in depth. With further chapters dedicated to regulatory aspects, gluten detection methods and the global market, this book presents full and up-to-date coverage of the development and manufacture of gluten-free products.
Development Of Biopharmaceutical Drug Device Products
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Author : Feroz Jameel
language : en
Publisher: Springer Nature
Release Date : 2020-03-13
Development Of Biopharmaceutical Drug Device Products written by Feroz Jameel and has been published by Springer Nature this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-03-13 with Medical categories.
The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.
Aggregation Of Therapeutic Proteins
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Author : Wei Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2010-12-28
Aggregation Of Therapeutic Proteins written by Wei Wang and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-12-28 with Medical categories.
This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.
Sustainable Protein Sources
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Author : Sudarshan Nadathur
language : en
Publisher: Elsevier
Release Date : 2023-11-17
Sustainable Protein Sources written by Sudarshan Nadathur and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-11-17 with Technology & Engineering categories.
Sustainable Protein Sources: Advances for a Healthier Tomorrow, Second Edition explores alternative proteins, including plant, fungal, algal and insect proteins that can take the place of meat as sustainable sources to satisfy human protein needs. This revised edition presents the benefits of plant and alternative protein consumption, including those that benefit the environment, population, and consumer trends and contains new chapters on potato protein, faba bean, chickpea, and coconut. Organized by protein, chapters also cover cereals and legumes, oilseeds, pseudocereals, fungi, algae, insects and fermentation-derived dairy and meat proteins paying particular attention to the nutrition, uses, functions, benefits, and challenges of each. The book also explores ways to improve utilization and addresses everything from consumer acceptability, methods of improving the taste of products containing these proteins and ways in which policies can affect the use of alternate proteins. In addition, the book addresses sustainable protein as a pathway to securing the food supply and considers regenerative versus extractive agriculture alongside new methods in farming and water usage. - Introduces the need to shift from animal-derived to plant-based protein and fermentation derived proteins - Discusses nutritive values of each protein source and compares each alternate protein to more complete proteins - Provides an overview of production, including processing, protein isolation, use cases and functionality
Soy Applications In Food
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Author : Mian N. Riaz
language : en
Publisher: CRC Press
Release Date : 2005-11-29
Soy Applications In Food written by Mian N. Riaz and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2005-11-29 with Technology & Engineering categories.
Soy is prized by the food industry for both its versatility and the major role it plays in food functionality. However, only a limited amount of information is available explaining soy's full potential in food applicability. Soy Applications in Food provides insight into the different types of soy ingredients available for consumption and details t
Current Challenges For The Aquatic Products Processing Industry
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Author : Véronique Verrez-Bagnis
language : en
Publisher: John Wiley & Sons
Release Date : 2024-01-31
Current Challenges For The Aquatic Products Processing Industry written by Véronique Verrez-Bagnis and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2024-01-31 with Technology & Engineering categories.
This book offers a state-of-the-art analysis on the main challenges facing the aquatic products processing industry. The topics explored are particularly relevant to the issues faced by European consumers and processors, but the information provided within this book can be widely extrapolated. This book should be helpful for processors, fish traders, consumers, scientists and students. The first chapter is dedicated to the sociological definition of "fish" and consumers’ perceptions. The following chapters deal with the notions of quality sensu lato, biological risks and their control, as well as the risks linked to the pollution of oceans and ecosystems by microplastics. Two types of processes and processed products – smoked fish and surimi products – which are of great economic importance to the European market, are also presented. The process of adding value to co-products, including the "blue biorefinery" and the innovative pH-shift technology are also covered in this book.
Comprehensive Biotechnology
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Author :
language : en
Publisher: Newnes
Release Date : 2011-08-26
Comprehensive Biotechnology written by and has been published by Newnes this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-08-26 with Science categories.
The second edition of Comprehensive Biotechnology, Six Volume Set continues the tradition of the first inclusive work on this dynamic field with up-to-date and essential entries on the principles and practice of biotechnology. The integration of the latest relevant science and industry practice with fundamental biotechnology concepts is presented with entries from internationally recognized world leaders in their given fields. With two volumes covering basic fundamentals, and four volumes of applications, from environmental biotechnology and safety to medical biotechnology and healthcare, this work serves the needs of newcomers as well as established experts combining the latest relevant science and industry practice in a manageable format. It is a multi-authored work, written by experts and vetted by a prestigious advisory board and group of volume editors who are biotechnology innovators and educators with international influence. All six volumes are published at the same time, not as a series; this is not a conventional encyclopedia but a symbiotic integration of brief articles on established topics and longer chapters on new emerging areas. Hyperlinks provide sources of extensive additional related information; material authored and edited by world-renown experts in all aspects of the broad multidisciplinary field of biotechnology Scope and nature of the work are vetted by a prestigious International Advisory Board including three Nobel laureates Each article carries a glossary and a professional summary of the authors indicating their appropriate credentials An extensive index for the entire publication gives a complete list of the many topics treated in the increasingly expanding field
Sterile Product Development
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Author : Parag Kolhe
language : en
Publisher: Springer Science & Business Media
Release Date : 2013-10-12
Sterile Product Development written by Parag Kolhe and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2013-10-12 with Medical categories.
This comprehensive book encompasses various facets of sterile product development. Key concepts relevant to the successful development of sterile products are illustrated through case studies and are covered under three sections in this book: • Formulation approaches that discuss a variety of dosage forms including protein therapeutics, lipid-based controlled delivery systems, PEGylated biotherapeutics, nasal dosage form, and vaccines • Process, container closure and delivery considerations including freeze-thaw process challenges, best practices for technology transfer to enable commercial product development, innovations and advancement in aseptic fill-finish operations, approaches to manufacturing lyophilized parenteral products, pen / auto-injector delivery devices, and associated container closure integrity testing hurdles for sterile product closures • Regulatory and quality aspects in the areas of particulate matter and appearance evaluation, sterile filtration, admixture compatibility considerations, sterilization process considerations, microbial contamination investigations and validation of rapid microbiological methods, and dry and moist heat sterilizers This book is a useful resource to scientists and researchers in both industry and academia, and it gives process and product development engineers insight into current industry practices and evolving regulatory expectations for sterile product development.