Challenges in Protein Product Development
Challenges in Protein Product Development

Author: Nicholas W. Warne

Publisher: Springer

Published: 2018-06-20

Total Pages: 596

ISBN-13: 3319906038

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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
Development and Manufacture of Protein Pharmaceuticals

Author: Steve L. Nail

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 479

ISBN-13: 1461505496

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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.

Principles and Practices of Lyophilization in Product Development and Manufacturing
Principles and Practices of Lyophilization in Product Development and Manufacturing

Author: Feroz Jameel

Publisher: Springer Nature

Published: 2023-04-24

Total Pages: 621

ISBN-13: 3031126343

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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.

Protein Instability at Interfaces During Drug Product Development
Protein Instability at Interfaces During Drug Product Development

Author: Jinjiang Li

Publisher: Springer Nature

Published: 2021-02-12

Total Pages: 338

ISBN-13: 3030571777

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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
Challenges and Potential Solutions in Gluten Free Product Development

Author: Navneet Singh Deora

Publisher: Springer Nature

Published: 2021-12-04

Total Pages: 191

ISBN-13: 3030886972

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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.

Protein Instability at Interfaces During Drug Product Development
Protein Instability at Interfaces During Drug Product Development

Author: Jinjiang Li

Publisher:

Published: 2021

Total Pages: 0

ISBN-13: 9783030571788

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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. .

Improving and Accelerating Therapeutic Development for Nervous System Disorders
Improving and Accelerating Therapeutic Development for Nervous System Disorders

Author: Institute of Medicine

Publisher: National Academies Press

Published: 2014-02-06

Total Pages: 107

ISBN-13: 0309292492

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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.

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition
Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

Author: Lars Hovgaard

Publisher: CRC Press

Published: 2012-11-14

Total Pages: 395

ISBN-13: 1439853886

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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
New Food Product Development

Author: Gordon W. Fuller

Publisher: CRC Press

Published: 1994-02-23

Total Pages: 302

ISBN-13: 9780849380020

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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.

Plant Protein Foods
Plant Protein Foods

Author: Annamalai Manickavasagan

Publisher: Springer

Published: 2022-04-19

Total Pages: 519

ISBN-13: 9783030912055

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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.