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Author: Feroz Jameel
Publisher: Springer Nature
ISBN: 3031126343
Category : Medical
Languages : en
Pages : 621
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Book Description
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.
Author: Feroz Jameel
Publisher: Springer Nature
ISBN: 3031126343
Category : Medical
Languages : en
Pages : 621
Get Book Here
Book Description
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.
Author: Thomas A. Jennings
Publisher: CRC Press
ISBN: 9781574910810
Category : Medical
Languages : en
Pages : 664
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Book Description
Finding consistent, analytical discussions of processes and principles of lyophilization can be challenging and often frustrating. The first resource to gather information about the field, Lyophilization: Introduction and Basic Principles is still the book to have on lyophilization. Presenting information in an easy-to-read style, the book comprehensively and authoritatively covers the field. Using plain, unpretentious language, author Thomas A. Jennings pulls together information from diverse sources to provide an authoritative compendium of the lyophilization process and its basic principles. He provides important discussions about the nature of the container-closure system and the equipment, tools, and environments required. Case studies and examples of solutions illustrate the many ways problems can be addressed in the lyophilization process. The book covers: Properties of lyophilized materials Product formulation requirements and the thermal properties of formulations Importance of process water Phase changes Thermal analytical methods Freezing, primary, and secondary drying processes Effect of vacuum freeze-dryers, both now and in the future Including over 150 illustrations, global symbols, and more than 350 references, this book is the complete guide to lyophilization, its analytical methods, measurement of process parameters, and equipment.
Author: Louis Rey
Publisher: CRC Press
ISBN:
Category : Business & Economics
Languages : en
Pages : 504
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Book Description
Highlights the application of freeze-drying to pharmaceuticals-illustrating practical & industry-tested methods of preserving & reactivating delicate biologicals & biochemicals. Discusses the basic principles & engineering aspects of lyophilization, & also the role of bulking agents, additives, cryoprotectants, antioxidants, free radicals, & other products that protect the biological integrity of active substances during freezing, drying, & storage.
Author: Felix Franks
Publisher: Royal Society of Chemistry
ISBN: 0854041516
Category : Medical
Languages : en
Pages : 220
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Book Description
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.
Author: Anil K. Sharma
Publisher: CRC Press
ISBN: 1000754197
Category : Medical
Languages : en
Pages : 376
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Book Description
This new volume, Herbal Product Development: Formulation and Applications, addresses some of the challenges that hinder the path of successful natural products from laboratory to market. Highly skilled, experienced, and renowned scientists and researchers from around the globe offer up-to-date information that describes characteristics of herbs and herbal products, applications, evaluation techniques, and more. There is also a section dedicated to alternative medicinal strategies for the treatment and cure of diverse diseases. Also considered, of course, is the efficacy and safety of herbal products, which are of major concern. This valuable volume will be an important addition to the library of those involved in herbal product development and testing, including researchers, scientists, academicians, industry professionals, and students in this area.
Author: Parag Kolhe
Publisher: Springer Science & Business Media
ISBN: 1461479789
Category : Medical
Languages : en
Pages : 590
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Book Description
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.
Author: Kevin R. Ward
Publisher: Humana Press
ISBN: 9781493989270
Category : Medical
Languages : en
Pages : 437
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Book Description
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.
Author: Feroz Jameel
Publisher: Springer
ISBN: 1493923161
Category : Medical
Languages : en
Pages : 710
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Book Description
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Author: Sheku Kamara
Publisher: John Wiley & Sons
ISBN: 1119750504
Category : Technology & Engineering
Languages : en
Pages : 192
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Book Description
Fundamentals of Additive Manufacturing for the Practitioner Discover how to shift from traditional to additive manufacturing processes with this core resource from industry leaders Fundamentals of Additive Manufacturing for the Practitioner delivers a vital examination of the methods and techniques needed to transition from traditional to additive manufacturing. The book explains how traditional manufacturing work roles change as various industries move into additive manufacturing and describes the flow of the typical production process in additive manufacturing. Detailed explorations of the processes, inputs, machine and build preparation, post-processing, and best practices are included, as well as real-world examples of the principles discussed within. Every chapter includes a problems and opportunities section that prompts readers to apply the book’s techniques to their own work. Diagrams and tables are distributed liberally throughout the work to present concepts visually, and key options and decisions are highlighted to assist the reader in understanding how additive manufacturing changes traditional workflows. Readers will also benefit from the inclusion of A thorough introduction on how to move into additive manufacturing, including the identification of a manufacturing opportunity and its characteristics An exploration of how to determine if additive manufacturing is the right solution, with descriptions of the origins of additive manufacturing and the current state of the technology An examination of the materials used in additive manufacturing, including polymers, composites, metals, plasters, and biomaterials A discussion of choosing an additive manufacturing technology and process Perfect for mechanical engineers, manufacturing professionals, technicians, and designers new to additive manufacturing, Fundamentals of Additive Manufacturing for the Practitioner will also earn a place in the libraries of technical, vocational, and continuing education audiences seeking to improve their skills with additive manufacturing workflows.
Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Category : Medical
Languages : en
Pages : 517
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Book Description
Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This
