This text is devoted to pharmaceutical freeze-drying in all its forms and in all its technological variations. Whether you freeze-dry nonsterile tablets or you lyophilize injectables, this book covers all the technological and regulatory requirements. Written by a panel of leading practitioners in the pharmaceutical industry -- production experts,
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
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.
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.
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.
Freeze-drying, or lyophilization, is a well established technology used in the preservation of numerous pharmaceutical and biological products. This highly effective dehydration method involves the removal of water from frozen materials via the direct sublimation of ice. In recent years, this process has met with many changes, as have the regulatio
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.
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.
Vaccine research and development is advancing at an unprecedented pace, with an increasing emphasis on rational design based upon a fundamental und- standing of the underlying molecular mechanisms. The aim of this volume is to provide a selection of contemporary protocols that will be useful to both novice and advanced practitioner alike. The variety of procedures required to design, develop, produce, and assess a vaccine is immense and covers aspects of ch- istry, biochemistry, molecular biology, cell biology, and immunology. No single volume can hope to cover these topics exclusively. Rather, here we attempt to provide a methods sourcebook focusing on hands-on practical advice. Comp- mentary and background information may be found in other volumes in the Me- ods in Molecular Medicine series. Of particular interest are volumes on Dendritic Cell Protocols, Interleukin Protocols, Vaccine Adjuvants, and DNA Vaccines. Since the publication of the first edition of Vaccine Protocols there have been major advances, particularly in the areas of bacterial genomics, antig- specific T-cell quantification, genetic manipulation of vaccine vectors, the h- nessing of natural molecules concerned with the regulation of immune responses, and the burgeoning field of DNA vaccinology. Hence, the extensive revision of this edition with new chapters on live viral vaccine vectors, atte- ated bacterial vectors, immunomodulators, MHC-peptide tetrameric complexes, and the identification of vaccine candidates by genomic analysis. Additionally, chapters from the first edition have been updated to accommodate state-of-t- art methods in vaccinology.
Pharmaceutical Dosage Forms: Parenteral Medications explores the administration of medications through other than the enteral route. First published in 1984 (as two volumes) and then last revised in 1993, this three-volume set presents the plethora of changes in the science and considerable advances in the technology associated with these products
