Challenges In Protein Product Development

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Challenges in Protein Product Development

Author : Nicholas W. Warne
Publisher : Springer
ISBN 13 : 3319906038
Total Pages : 596 pages
Book Rating : 4.3/5 (199 download)

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Book Synopsis Challenges in Protein Product Development by : Nicholas W. Warne

Download or read book Challenges in Protein Product Development written by Nicholas W. Warne and published by Springer. This book was released on 2018-06-20 with total page 596 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Development and Manufacture of Protein Pharmaceuticals

Author : Steve L. Nail
Publisher : Springer Science & Business Media
ISBN 13 : 1461505496
Total Pages : 479 pages
Book Rating : 4.4/5 (615 download)

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Book Synopsis Development and Manufacture of Protein Pharmaceuticals by : Steve L. Nail

Download or read book Development and Manufacture of Protein Pharmaceuticals written by Steve L. Nail and published by Springer Science & Business Media. This book was released on 2012-12-06 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

Author : Lars Hovgaard
Publisher : CRC Press
ISBN 13 : 1439853886
Total Pages : 395 pages
Book Rating : 4.4/5 (398 download)

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Book Synopsis Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition by : Lars Hovgaard

Download or read book Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition written by Lars Hovgaard and published by CRC Press. This book was released on 2012-11-14 with total page 395 pages. Available in PDF, EPUB and Kindle. Book excerpt: The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

New Food Product Development

Author : Gordon W. Fuller
Publisher : CRC Press
ISBN 13 : 9780849380020
Total Pages : 302 pages
Book Rating : 4.3/5 (8 download)

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Book Synopsis New Food Product Development by : Gordon W. Fuller

Download or read book New Food Product Development written by Gordon W. Fuller and published by CRC Press. This book was released on 1994-02-23 with total page 302 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides an objective overview of the hectic, often chaotic, and frequently unpredictable new food product development process. The stages of development are described from the vantage points of the technologist, marketer, and senior management by an author who has worn all three hats. The book covers the various stages of product development, including generating and sifting ideas against the company's objectives, the consumers' perceived needs and expectations, the competitiveness of the marketplace, the technologist's ability to create and manufacture a safe product within budget, and test marketing. Problems facing both small and large companies are confronted and solutions are proposed. Test marketing and the evaluation of such tests are discussed with some new suggestions for interpreting the criteria used. A chapter on organization presents ideas for fostering creativity and avoiding communication and personality conflicts. Trends in new ingredients and technologies to assist in the design of new products are given full coverage. The last chapter is devoted to the future, with stimulating discussion of new challenges to current trends in the industry.

Principles and Practices of Lyophilization in Product Development and Manufacturing

Author : Feroz Jameel
Publisher : Springer Nature
ISBN 13 : 3031126343
Total Pages : 621 pages
Book Rating : 4.0/5 (311 download)

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Book Synopsis Principles and Practices of Lyophilization in Product Development and Manufacturing by : Feroz Jameel

Download or read book Principles and Practices of Lyophilization in Product Development and Manufacturing written by Feroz Jameel and published by Springer Nature. This book was released on 2023-04-24 with total page 621 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Biopharmaceutical Drug Design and Development

Author : Susanna Wu-Pong
Publisher : Springer Science & Business Media
ISBN 13 : 1597455326
Total Pages : 374 pages
Book Rating : 4.5/5 (974 download)

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Book Synopsis Biopharmaceutical Drug Design and Development by : Susanna Wu-Pong

Download or read book Biopharmaceutical Drug Design and Development written by Susanna Wu-Pong and published by Springer Science & Business Media. This book was released on 2010-01-11 with total page 374 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides a comprehensive examination of the newest biopharmaceutical drugs. Among the drugs discussed are ones in the categories of monoclonal antibodies for in-vivo use, cytokines, growth factors, enzymes, immunomodulators, thrombolytics, and immonotherapies including vaccines. Additionally, the volume examines new and emerging technologies, and contains a review of the Human Genome Project.

Protein Instability at Interfaces During Drug Product Development

Author : Jinjiang Li
Publisher : Springer Nature
ISBN 13 : 3030571777
Total Pages : 338 pages
Book Rating : 4.0/5 (35 download)

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Book Synopsis Protein Instability at Interfaces During Drug Product Development by : Jinjiang Li

Download or read book Protein Instability at Interfaces During Drug Product Development written by Jinjiang Li and published by Springer Nature. This book was released on 2021-02-12 with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.

Challenges and Potential Solutions in Gluten Free Product Development

Author : Navneet Singh Deora
Publisher : Springer Nature
ISBN 13 : 3030886972
Total Pages : 191 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Challenges and Potential Solutions in Gluten Free Product Development by : Navneet Singh Deora

Download or read book Challenges and Potential Solutions in Gluten Free Product Development written by Navneet Singh Deora and published by Springer Nature. This book was released on 2021-12-04 with total page 191 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author : Institute of Medicine
Publisher : National Academies Press
ISBN 13 : 0309292492
Total Pages : 107 pages
Book Rating : 4.3/5 (92 download)

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Book Synopsis Improving and Accelerating Therapeutic Development for Nervous System Disorders by : Institute of Medicine

Download or read book Improving and Accelerating Therapeutic Development for Nervous System Disorders written by Institute of Medicine and published by National Academies Press. This book was released on 2014-02-06 with total page 107 pages. Available in PDF, EPUB and Kindle. Book excerpt: Improving and Accelerating Therapeutic Development for Nervous System Disorders is the summary of a workshop convened by the IOM Forum on Neuroscience and Nervous System Disorders to examine opportunities to accelerate early phases of drug development for nervous system drug discovery. Workshop participants discussed challenges in neuroscience research for enabling faster entry of potential treatments into first-in-human trials, explored how new and emerging tools and technologies may improve the efficiency of research, and considered mechanisms to facilitate a more effective and efficient development pipeline. There are several challenges to the current drug development pipeline for nervous system disorders. The fundamental etiology and pathophysiology of many nervous system disorders are unknown and the brain is inaccessible to study, making it difficult to develop accurate models. Patient heterogeneity is high, disease pathology can occur years to decades before becoming clinically apparent, and diagnostic and treatment biomarkers are lacking. In addition, the lack of validated targets, limitations related to the predictive validity of animal models - the extent to which the model predicts clinical efficacy - and regulatory barriers can also impede translation and drug development for nervous system disorders. Improving and Accelerating Therapeutic Development for Nervous System Disorders identifies avenues for moving directly from cellular models to human trials, minimizing the need for animal models to test efficacy, and discusses the potential benefits and risks of such an approach. This report is a timely discussion of opportunities to improve early drug development with a focus toward preclinical trials.

Fusion Protein Technologies for Biopharmaceuticals

Author : Stefan R. Schmidt
Publisher : John Wiley & Sons
ISBN 13 : 1118354583
Total Pages : 995 pages
Book Rating : 4.1/5 (183 download)

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Book Synopsis Fusion Protein Technologies for Biopharmaceuticals by : Stefan R. Schmidt

Download or read book Fusion Protein Technologies for Biopharmaceuticals written by Stefan R. Schmidt and published by John Wiley & Sons. This book was released on 2013-01-28 with total page 995 pages. Available in PDF, EPUB and Kindle. Book excerpt: The state of the art in biopharmaceutical FUSION PROTEIN DESIGN Fusion proteins belong to the most lucrative biotech drugs—with Enbrel® being one of the best-selling biologics worldwide. Enbrel® represents a milestone of modern therapies just as Humulin®, the first therapeutic recombinant protein for human use, approved by the FDA in 1982 and Orthoclone® the first monoclonal antibody reaching the market in 1986. These first generation molecules were soon followed by a plethora of recombinant copies of natural human proteins, and in 1998, the first de novo designed fusion protein was launched. Fusion Protein Technologies for Biopharmaceuticals examines the state of the art in developing fusion proteins for biopharmaceuticals, shedding light on the immense potential inherent in fusion protein design and functionality. A wide pantheon of international scientists and researchers deliver a comprehensive and complete overview of therapeutic fusion proteins, combining the success stories of marketed drugs with the dynamic preclinical and clinical research into novel drugs designed for as yet unmet medical needs. The book covers the major types of fusion proteins—receptor-traps, immunotoxins, Fc-fusions and peptibodies—while also detailing the approaches for developing, delivering, and improving the stability of fusion proteins. The main body of the book contains three large sections that address issues key to this specialty: strategies for extending the plasma half life, the design of toxic proteins, and utilizing fusion proteins for ultra specific targeting. The book concludes with novel concepts in this field, including examples of highly relevant multifunctional antibodies. Detailing the innovative science, commercial realities, and brilliant potential of fusion protein therapeutics, Fusion Protein Technologies for Biopharmaceuticals is a must for pharmaceutical scientists, biochemists, medicinal chemists, molecular biologists, pharmacologists, and genetic engineers interested in determining the shape of innovation in the world of biopharmaceuticals.

Development of Biopharmaceutical Drug-Device Products

Author : Feroz Jameel
Publisher : Springer Nature
ISBN 13 : 3030314154
Total Pages : 888 pages
Book Rating : 4.0/5 (33 download)

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Book Synopsis Development of Biopharmaceutical Drug-Device Products by : Feroz Jameel

Download or read book Development of Biopharmaceutical Drug-Device Products written by Feroz Jameel and published by Springer Nature. This book was released on 2020-03-13 with total page 888 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.

Protein Instability at Interfaces During Drug Product Development

Author : Jinjiang Li
Publisher :
ISBN 13 : 9783030571788
Total Pages : 0 pages
Book Rating : 4.5/5 (717 download)

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Book Synopsis Protein Instability at Interfaces During Drug Product Development by : Jinjiang Li

Download or read book Protein Instability at Interfaces During Drug Product Development written by Jinjiang Li and published by . This book was released on 2021 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas. .

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Author : Feroz Jameel
Publisher : John Wiley & Sons
ISBN 13 : 0470595876
Total Pages : 986 pages
Book Rating : 4.4/5 (75 download)

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Book Synopsis Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by : Feroz Jameel

Download or read book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals written by Feroz Jameel and published by John Wiley & Sons. This book was released on 2010-07-13 with total page 986 pages. Available in PDF, EPUB and Kindle. Book excerpt: A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Plant Protein Foods

Author : Annamalai Manickavasagan
Publisher : Springer
ISBN 13 : 9783030912055
Total Pages : 519 pages
Book Rating : 4.9/5 (12 download)

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Book Synopsis Plant Protein Foods by : Annamalai Manickavasagan

Download or read book Plant Protein Foods written by Annamalai Manickavasagan and published by Springer. This book was released on 2022-04-19 with total page 519 pages. Available in PDF, EPUB and Kindle. Book excerpt: Regular consumption of plant-based protein foods instead of animal-based protein foods reduces the risk factors for cardiovascular diseases, diabetes and certain cancers. Apart from human health, the adverse effects to the environment due to the production of protein is much higher for animal sources than plant sources. Greenhouse gas emissions from the production of one pound of lamb meat, for example, are thirty times higher than one pound of lentils. As consumers are increasingly aware of personal health and environmental impact of food production, the demand for plant protein foods is increasing globally. This trend has prompted several large-scale collaborative research projects on plant-based protein products supported by the industry and governmental agencies. Several established multinational meat companies have started adding plant-protein product lines to meet the current demand. This book presents the first comprehensive compilation of literature on plant-based protein foods. Chapters cover protein extraction technologies from plants, comparison of amino acid profiles of plant- and animal-based proteins, approaches to product development for plant-based protein products, health benefits of plant-based protein foods, market opportunities, and future challenges. Plant Protein Foods is an essential reference for consumers, students, researchers, food manufacturers and other stakeholders interested in this domain.

Innovative Dosage Forms

Author : Yogeshwar Bachhav
Publisher : John Wiley & Sons
ISBN 13 : 3527343962
Total Pages : 470 pages
Book Rating : 4.5/5 (273 download)

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Book Synopsis Innovative Dosage Forms by : Yogeshwar Bachhav

Download or read book Innovative Dosage Forms written by Yogeshwar Bachhav and published by John Wiley & Sons. This book was released on 2019-12-04 with total page 470 pages. Available in PDF, EPUB and Kindle. Book excerpt: Teaches future and current drug developers the latest innovations in drug formulation design and optimization This highly accessible, practice-oriented book examines current approaches in the development of drug formulations for preclinical and clinical studies, including the use of functional excipients to enhance solubility and stability. It covers oral, intravenous, topical, and parenteral administration routes. The book also discusses safety aspects of drugs and excipients, as well as regulatory issues relevant to formulation. Innovative Dosage Forms: Design and Development at Early Stage starts with a look at the impact of the polymorphic form of drugs on the preformulation and formulation development. It then offers readers reliable strategies for the formulation development of poorly soluble drugs. The book also studies the role of reactive impurities from the excipients on the formulation shelf life; preclinical formulation assessment of new chemical entities; and regulatory aspects for formulation design. Other chapters cover innovative formulations for special indications, including oncology injectables, delayed release and depot formulations; accessing pharmacokinetics of various dosage forms; physical characterization techniques to assess amorphous nature; novel formulations for protein oral dosage; and more. -Provides information that is essential for the drug development effort -Presents the latest advances in the field and describes in detail innovative formulations, such as nanosuspensions, micelles, and cocrystals -Describes current approaches in early pre-formulation to achieve the best in vivo results -Addresses regulatory and safety aspects, which are key considerations for pharmaceutical companies -Includes case studies from recent drug development programs to illustrate the practical challenges of preformulation design Innovative Dosage Forms: Design and Development at Early Stage provides valuable benefits to interdisciplinary drug discovery teams working in industry and academia and will appeal to medicinal chemists, pharmaceutical chemists, and pharmacologists.

Novel Plant Protein Processing

Author : Zakir Showkat Khan
Publisher : CRC Press
ISBN 13 : 1003812686
Total Pages : 449 pages
Book Rating : 4.0/5 (38 download)

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Book Synopsis Novel Plant Protein Processing by : Zakir Showkat Khan

Download or read book Novel Plant Protein Processing written by Zakir Showkat Khan and published by CRC Press. This book was released on 2023-12-29 with total page 449 pages. Available in PDF, EPUB and Kindle. Book excerpt: Proteins serve as an important nutritional as well as structural component of foods. Not only do they provide an array of amino acids necessary for maintaining human health but also act as thickening, stabilizing, emulsifying, foaming, gelling, and binding agents. The ability of a protein to possess and demonstrate such unique functional properties depends largely on its inherent structure, configuration, and how they interact with other food constituents, like, polysaccharides, lipids, and polyphenolic compounds. Proteins from animal sources have superior functionality, higher digestibility, and lower anti-nutrient components than plant proteins. However, consumer preferences are evolving worldwide for ethically and sustainably sourced, clean, cruelty-free, vegan or vegetarian plant-based food products. Unlike proteins from animal sources, plant proteins are more versatile, religiously, and culturally acceptable among vegetarian and vegan consumers and associated with lower food processing waste, water, and soil requirement. Thus, the processing and utilization of plant proteins have gained worldwide attention and as such numerous scientific studies are focusing on enhancing the utilization of plant proteins in food and pharmaceutical products through various processing and modification techniques to improve their techno-functional properties, bioactivity, bioavailability, and digestibility. Novel Plant Protein Processing: Developing the Foods of the Future presents a roadmap for plant protein science, and technology which will focus on plant protein ingredient development, plant protein modification, and the creation of plant protein-based novel foods. Key Features: · Includes complete information about novel plant protein processing for use as future foods · Presents a roadmap to upscale the meat analog technological processes · Discusses marketing limitations of plant based proteins and future opportunities This book highlights the important scientific, technological advancements that are being deployed in the future foods using plant proteins, concerns, opportunities, and challenges, and, as an alternative to maintaining a healthy and sustainable modern food supply. It covers the most recent research related to the plant protein-based future foods which include their extraction, isolation, modification, characterization, development, and final applications. It also covers the formulation and challenges: emphasis on the modification for a specific use, legal aspects, business perspective, and future challenges. This book is useful for researchers, readers, scientists, and industrial people to find information easily.

Sterile Product Development

Author : Parag Kolhe
Publisher : Springer Science & Business Media
ISBN 13 : 1461479789
Total Pages : 590 pages
Book Rating : 4.4/5 (614 download)

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Book Synopsis Sterile Product Development by : Parag Kolhe

Download or read book Sterile Product Development written by Parag Kolhe and published by Springer Science & Business Media. This book was released on 2013-10-12 with total page 590 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.