Freeze Drying Of Pharmaceutical And Food Products

Freeze-drying is an important preservation technique for heat-sensitive pharmaceuticals and foods. Products are first frozen, then dried in a vacuum at low temperature by sublimation and desorption, rather than by the application of heat. The resulting items can be stored at room temperature for long periods. This informative text addresses both principles and practice in this area. The first chapter introduces freeze-drying. The authors then review the fundamentals of the technique, heat-mass transfer analyses, modelling of the drying process and the equipment employed. Further chapters focus on freeze-drying of food, freeze-drying of pharmaceuticals and the protective agents and additives applied. The final chapter covers the important subjects of disinfection, sterilization and process validation. Freeze-drying of pharmaceutical and food products is an essential reference for food, pharmaceutical and refrigeration engineers and scientists with an interest in preservation techniques. It will also be of use to students in these fields. Addresses the principles and practices used in this important preservation technique Explains the fundamentals of heat-mass transfer analysis, modelling and the equipment used Discusses the importance of disinfection, sterilization and process validation

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.

Aimed at product and process developers in the biopharmaceutical industry and academia, this is the first book to describe freeze-drying, as related to the pharmaceutical industry.

"This book reviews the spray-freeze-drying technique, its history, engineering principles of each of the stages, various applications, functional properties of spray-freeze-dried products and their characterization"--

A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

This completely updated and enlarged third edition of the classic text adopts a practical approach to describe the fundamentals of freeze-drying, backed by many explanatory examples. Following an introduction to the fundamentals, the book goes on to discuss process and plant automation as well as methods to transfer pilot plant qualifications and process data to production. An entire section is devoted to a large range of different pharmaceutical, biological, and medical products. New to this edition are chapters on antibodies, freeze-dry microscopy, TEMPRIS, microwave freeze-drying, spray freeze-drying, and PAT. Their many years of experience in freeze-drying enable the authors to supply valuable criteria for the selection of laboratory, pilot and production plants, discussing the advantages, drawbacks and limitations of different plant designs. Alongside guidelines for the evaluation and qualification of plants and processes, the author also includes a troubleshooting section.

This Special Issue provides an update on the most recent research and developments in the area of freeze-drying technology in foods. It presents a combination of experimental and modeling studies, offering an overview of oncoming challenges and opportunities on the topic.

Herbal products have traditionally been used in several industrial sectors and have gained a notable reputation in recent years due to the current trend in society, which seeks natural, healthier, and more sustainable products. The processing of these products, however, is multiplex but important for the production of a high-quality standardised product. Phytotechnology: A Sustainable Platform for the Development of Herbal Products highlights the complex, multidisciplinary process of phytopharmaceutical technology used to create herbal remedies. Organised into four parts, various experts in the field clearly and objectively address the fundamental and technological concepts involved in the manufacturing of high-quality herbal products. Additional Features Emphasises how herbal products have traditionally been used in several industrial sectors, including pharmaceutical science, food, cosmetics, chemical engineering, and agroindustry Provides a much-needed update of the current information regarding phytopharmaceutical technology and focuses on industrial applications Written using a multidisciplinary approach, to include all subjects involved in the processing of herbal products The information presented is valuable reference material for professionals of different specialties who wish to enter this fascinating and innovative area.

The Encyclopedia of Food and Health provides users with a solid bridge of current and accurate information spanning food production and processing, from distribution and consumption to health effects. The Encyclopedia comprises five volumes, each containing comprehensive, thorough coverage, and a writing style that is succinct and straightforward. Users will find this to be a meticulously organized resource of the best available summary and conclusions on each topic. Written from a truly international perspective, and covering of all areas of food science and health in over 550 articles, with extensive cross-referencing and further reading at the end of each chapter, this updated encyclopedia is an invaluable resource for both research and educational needs. Identifies the essential nutrients and how to avoid their deficiencies Explores the use of diet to reduce disease risk and optimize health Compiles methods for detection and quantitation of food constituents, food additives and nutrients, and contaminants Contains coverage of all areas of food science and health in nearly 700 articles, with extensive cross-referencing and further reading at the end of each chapter

Filling a gap in the literature, this is the first book to focus on the fabrication of functional porous materials by using ice templating and freeze drying. Comprehensive in its scope, the volume covers such techniques as the fabrication of porous polymers, porous ceramics, biomimic strong composites, carbon nanostructured materials, nanomedicine, porous nanostructures by freeze drying of colloidal or nanoparticle suspensions, and porous materials by combining ice templating and other techniques. In addition, applications for each type of material are also discussed. Of great benefit to those working in the freeze-drying field and researchers in porous materials, materials chemistry, engineering, and the use of such materials for various applications, both in academia and industry.

A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

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.

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.

Thoroughly acquainting the reader with freeze-drying fundamentals, Freeze-Drying/Lyophilization of Pharmaceutical and Biological Products, Second Edition carves practical guidelines from the very latest theoretical research, technologies, and industrial procedures. It delineates the best execution of steps from closure preparation and regulatory control of products to equipment sterilization and process validation. With 13 new chapters providing state-of-the-art information, the book unveils innovations currently advancing the field, including LYOGUARD® packaging for bulk freeze-drying and the irradiation of pharmaceutical and biological products.

This detailed volume brings together leading practitioners in the freeze-drying community to address recent progress, not only in new analytical tools and applications of the data derived in cycle design but also in the manufacturing of lyophilized products in the healthcare sector – whether these be therapeutics, vaccines or diagnostic products - and indeed the equipment to deliver this scale of freeze-drying. Areas of focus include analytical and formulation issues, process monitoring and control, as well as post-lyophilization analysis. Written for the Methods in Pharmacology and Toxicology series, chapters include the type of expert advice that leads to superior results in the lab. Authoritative and practical, Lyophilization of Pharmaceuticals and Biologicals: New Technologies and Approaches serves as an ideal guide for researchers working in or just seeking an update on this rapidly changing field.

Spray-freeze-drying (SFD) is a synergistic drying technology that imbibes in it the merits of both spray drying and freeze-drying, whilst overcoming the limitations of these predecessor technologies. SFD produces uniquely powdered food and pharmaceutical products with porous microstructure and superior quality attributes. Owing to its atomization step and ultra-low-temperature operation, SFD is a competent drying technique for the production of valuable but sensitive bioactive components. Despite the costs and complexities involved, SFD has a competitive edge over the conventional drying techniques in providing distinctive product attributes. The applications of spray-freeze-drying in the area of food and bioproducts span across the product categories of instant food powders, dry flavors, active pharmaceutical ingredients, poorly water-soluble drugs, probiotics, proteins, enzymes and vaccines. Spray-Freeze-Drying of Foods and Bioproducts: Theory, Applications and Perspectives is the first exclusive title on this interesting drying technique. It provides a comprehensive understanding of the fundamentals of SFD and its food and pharmaceutical applications. The scope of this book, comprising 12 chapters, has been organizedunder four major headings: fundamentals of process-stages, applications with case-studies, recent advancements and the processing bottlenecks and solutions. Key Features Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics and flavors Serves as a ready-reckoner of characterization methods for spray-freeze-dried products Contains 200+ illustrations and tabulations The contents of this book are organized to cater to the knowledge needs of students, academicians, researchers and professionals in the food and pharmaceutical industry.

Spray-freeze-drying (SFD) is a synergistic drying technology that imbibes in it the merits of both spray drying and freeze-drying, whilst overcoming the limitations of these predecessor technologies. SFD produces uniquely powdered food and pharmaceutical products with porous microstructure and superior quality attributes. Owing to its atomization step and ultra-low-temperature operation, SFD is a competent drying technique for the production of valuable but sensitive bioactive components. Despite the costs and complexities involved, SFD has a competitive edge over the conventional drying techniques in providing distinctive product attributes. The applications of spray-freeze-drying in the area of food and bioproducts span across the product categories of instant food powders, dry flavors, active pharmaceutical ingredients, poorly water-soluble drugs, probiotics, proteins, enzymes and vaccines. Spray-Freeze-Drying of Foods and Bioproducts: Theory, Applications and Perspectives is the first exclusive title on this interesting drying technique. It provides a comprehensive understanding of the fundamentals of SFD and its food and pharmaceutical applications. The scope of this book, comprising 12 chapters, has been organizedunder four major headings: fundamentals of process-stages, applications with case-studies, recent advancements and the processing bottlenecks and solutions. Key Features Provides examples and case studies of nuances and intricacies associated with each stage of the spray-freeze-drying process Highlights the applications of spray-freeze-drying in the production of food products including soluble coffee, dairy powders, probiotics and flavors Serves as a ready-reckoner of characterization methods for spray-freeze-dried products Contains 200+ illustrations and tabulations The contents of this book are organized to cater to the knowledge needs of students, academicians, researchers and professionals in the food and pharmaceutical industry.

The development of food and drink products for children and adolescents represents an expanding market sector, which has received little attention in the existing literature. In recognition of increasing concerns regarding diet and nutrition in children and their potential impact on nutrition-related health issues in later life, this book covers three broad aspects relating to developing children’s food products – nutrition and health, children’s food choices, and the design and testing of food and drink products for children. Part one covers topical issues in pre-adult nutrition and health, such as nutritional requirements, fluid intake needs, diet and behaviour and growing 20th century health problems such as childhood obesity and food allergies. Part two then focuses on children’s food choices, addressing food promotion and food choice in children and strategies that can be used to improve children’s food choices both inside and outside of the home. Finally, part three considers the design of food and drink products for children, with an emphasis on working with children and adolescents to design food and drink products, and how best to undertake consumer and sensory testing with children. With its team of expert international contributors, Developing children’s food products is an essential resource for both academics and food industry professionals, offering particular assistance to product developers working within the competitive children’s market. Covers topical issues in pre-adult nutrition and health, discussing diet and behaviour and growing health problems such as childhood obesity and food allergies Reviews children’s food choices, addressing food promotion and food choice in children and strategies that can be used to improve children’s food choices Considers the design of food and drink products for children, with an emphasis on working with children and how best to undertake testing

Developing Food Products for Customers with Specific Dietary Needs explains the process for developing foods for customers who have specific dietary needs, further shining a light on the number of increasing medical conditions related to food intake that have emerged in the past few decades. From increased fat and sugar intake leading to higher levels of obesity, to greater levels of coeliac disease, the ingredients and nutritional content of food is becoming more and more important. Additionally, consumers are following particular diets for many different reasons, be it health related, or for religious or moral reasons. The first part of the book looks, in detail, at the organizational structure required within a company to allow for the development of food products which meet the needs of these customers, while the second part presents a number of case studies highlighting the development of food products for various dietary requirements. Precise coverage includes section on the development of low-sodium, low-sugar, low-fat, and low-carbohydrate products with the aim of producing healthier foods, as well as the development of organic and vegetarian products for consumers who are following diets for personal reasons. The potential solutions for developing foods for customers who have specific dietary needs are likely to include both ingredients and technology developments. The ingredients area includes simple reductions as well as replacement strategies, whilst technology will be applied to both the ingredient itself and the host food product. All are aimed at maintaining the product quality as perceived by the customer. Provides an overview of the organizational structure required within a company to develop foods for specific customer needs Includes section on the development of low-sodium, low-sugar, low-fat, and low-carbohydrate products with the aim of producing healthier foods Presents case studies that deliver a best practice view on developing foods for customers with specific dietary needs Written by industry professionals, this book offers in-depth coverage of this topic of ever increasing importance to the food industry