Lyophilized Biologics And Vaccines

Lyophilized Biologics And Vaccines Book in PDF, ePub and Kindle version is available to download in english. Read online anytime anywhere directly from your device. Click on the download button below to get a free pdf file of Lyophilized Biologics And Vaccines book. This book definitely worth reading, it is an incredibly well-written.

Lyophilized Biologics and Vaccines

Dushyant Varshney,Manmohan Singh
Lyophilized Biologics and Vaccines Book PDF

Author : Dushyant Varshney,Manmohan Singh
Publisher : Springer
Page : 401 pages
File Size : 45,9 Mb
Release : 2015-05-19
Category : Medical
ISBN : 9781493923830

Get Book

Lyophilized Biologics and Vaccines by Dushyant Varshney,Manmohan Singh Pdf

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Drying Technologies for Biotechnology and Pharmaceutical Applications Book PDF

Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publisher : John Wiley & Sons
Page : 394 pages
File Size : 42,9 Mb
Release : 2020-06-02
Category : Medical
ISBN : 9783527341122

Get Book

Drying Technologies for Biotechnology and Pharmaceutical Applications by Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros Pdf

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.

Canadian Immunization Guide

Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization
Canadian Immunization Guide Book PDF

Author : Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization
Publisher : Unknown
Page : 392 pages
File Size : 43,8 Mb
Release : 2006
Category : Immunization
ISBN : 0660193922

Get Book

Canadian Immunization Guide by Canada. Comité consultatif national de l'immunisation,Canada. National Advisory Committee on Immunization Pdf

The seventh edition of the Canadian Immunization Guide was developed by the National Advisory Committee on Immunization (NACI), with the support ofthe Immunization and Respiratory Infections Division, Public Health Agency of Canada, to provide updated information and recommendations on the use of vaccines in Canada. The Public Health Agency of Canada conducted a survey in 2004, which confi rmed that the Canadian Immunization Guide is a very useful and reliable resource of information on immunization.

Lyophilization of Biopharmaceuticals

Henry R. Costantino,Michael J. Pikal
Lyophilization of Biopharmaceuticals Book PDF

Author : Henry R. Costantino,Michael J. Pikal
Publisher : Springer Science & Business Media
Page : 726 pages
File Size : 54,5 Mb
Release : 2005-12-05
Category : Medical
ISBN : 0971176760

Get Book

Lyophilization of Biopharmaceuticals by Henry R. Costantino,Michael J. Pikal Pdf

Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state.

Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition E-Book

Jennifer Hamborsky, MPH, MCHES,Andrew Kroger, MD, MPH,Charles (Skip) Wolfe
Epidemiology and Prevention of Vaccine Preventable Diseases 13th Edition E Book Book PDF

Author : Jennifer Hamborsky, MPH, MCHES,Andrew Kroger, MD, MPH,Charles (Skip) Wolfe
Publisher : Public Health Foundation
Page : 512 pages
File Size : 49,6 Mb
Release : 2015-10-19
Category : Health & Fitness
ISBN : 9780990449126

Get Book

Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition E-Book by Jennifer Hamborsky, MPH, MCHES,Andrew Kroger, MD, MPH,Charles (Skip) Wolfe Pdf

The Public Health Foundation (PHF) in partnership with the Centers for Disease Control and Prevention (CDC) is pleased to announce the availability of Epidemiology and Prevention of Vaccine-Preventable Diseases, 13th Edition or “The Pink Book” E-Book. This resource provides the most current, comprehensive, and credible information on vaccine-preventable diseases, and contains updated content on immunization and vaccine information for public health practitioners, healthcare providers, health educators, pharmacists, nurses, and others involved in administering vaccines. “The Pink Book E-Book” allows you, your staff, and others to have quick access to features such as keyword search and chapter links. Online schedules and sources can also be accessed directly through e-readers with internet access. Current, credible, and comprehensive, “The Pink Book E-Book” contains information on each vaccine-preventable disease and delivers immunization providers with the latest information on: Principles of vaccination General recommendations on immunization Vaccine safety Child/adult immunization schedules International vaccines/Foreign language terms Vaccination data and statistics The E-Book format contains all of the information and updates that are in the print version, including: · New vaccine administration chapter · New recommendations regarding selection of storage units and temperature monitoring tools · New recommendations for vaccine transport · Updated information on available influenza vaccine products · Use of Tdap in pregnancy · Use of Tdap in persons 65 years of age or older · Use of PCV13 and PPSV23 in adults with immunocompromising conditions · New licensure information for varicella-zoster immune globulin Contact [email protected] for more information. For more news and specials on immunization and vaccines visit the Pink Book's Facebook fan page

Principles and Practices of Lyophilization in Product Development and Manufacturing

Feroz Jameel
Principles and Practices of Lyophilization in Product Development and Manufacturing Book PDF

Author : Feroz Jameel
Publisher : Springer Nature
Page : 621 pages
File Size : 45,5 Mb
Release : 2023-04-24
Category : Medical
ISBN : 9783031126345

Get Book

Principles and Practices of Lyophilization in Product Development and Manufacturing by Feroz Jameel Pdf

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.

Vaccine Protocols

Andrew P. Robinson,Martin P. Cranage,Michael J. Hudson
Vaccine Protocols Book PDF

Author : Andrew P. Robinson,Martin P. Cranage,Michael J. Hudson
Publisher : Humana Press
Page : 416 pages
File Size : 41,9 Mb
Release : 2003-08-27
Category : Medical
ISBN : 1588291405

Get Book

Vaccine Protocols by Andrew P. Robinson,Martin P. Cranage,Michael J. Hudson Pdf

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.

Spray Drying of Vaccines

Cordin Arpagaus
Spray Drying of Vaccines Book PDF

Author : Cordin Arpagaus
Publisher : Springer Nature
Page : 610 pages
File Size : 43,9 Mb
Release : 2023-04-03
Category : Medical
ISBN : 9783031243233

Get Book

Spray Drying of Vaccines by Cordin Arpagaus Pdf

This book addresses the stabilization of vaccine powders by spray drying and provides an overview of the current state of the art on a laboratory and industrial scale. The book aims to familiarize readers with the advances in vaccine spray drying technology to understand its application potential better. In particular, the book addresses the design of aseptic spray dryers, parameters affecting the spray drying process, sterile powder processing, cleaning procedures, and powder filling. In addition, different drying technologies for the production of dry powder vaccines are compared to discuss the unique capabilities of spray drying as a particle technology for vaccines. Special attention is given to research studies on spray-dried vaccines published over the past 30 years, with key findings from laboratory research to clinical trials. Potential applications of spray-dried vaccines and routes of administration are presented in detail. Finally, an outlook is given on how close the aseptic spray-drying of vaccines is to the market and the challenges that need to be overcome to be commercially successful. The book's target audience is academics, researchers, vaccine developers, industry experts, students, and possibly funders, including government agencies, who are active in the field. In addition, the book is a reference source for those involved in the vaccine formulation and biopharmaceutical processing industry.

Practical Aspects of Vaccine Development

Parag Kolhe,Satoshi Ohtake
Practical Aspects of Vaccine Development Book PDF

Author : Parag Kolhe,Satoshi Ohtake
Publisher : Elsevier
Page : 386 pages
File Size : 49,8 Mb
Release : 2021-09-08
Category : Business & Economics
ISBN : 9780128143575

Get Book

Practical Aspects of Vaccine Development by Parag Kolhe,Satoshi Ohtake Pdf

Formulation, Development and Manufacturing of Vaccines: The Practical Aspects provides an industry perspective on vaccine product development and manufacture that covers their formulation development, manufacture and delivery/in-use considerations of vaccine production. With the increasing complexity of vaccine products in development, there is a need for a comprehensive review of the current state of the industry and its challenges. While formulation scientists working in biotherapeutic development may be familiar with proteins, vaccines present unique challenges, including the wide range of vaccine components that may comprise proteins, polysaccharides, protein-polysaccharide conjugates, adjuvants, etc. and the varying stability and behavior of solution- and suspension-based systems. This book is an essential resource for formulation scientists, researchers in vaccine development throughout medical and life sciences, and advanced students. Includes formulation considerations for various vaccine types, including proteins, polysaccharides, conjugates and live vaccines Considers process development for solution, suspension and lyophilized products Explores the future potential of vaccines, including multi-component vaccines and novel delivery mechanisms/devices

Drying Technologies for Biotechnology and Pharmaceutical Applications

Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Drying Technologies for Biotechnology and Pharmaceutical Applications Book PDF

Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publisher : John Wiley & Sons
Page : 400 pages
File Size : 44,5 Mb
Release : 2020-02-03
Category : Medical
ISBN : 9783527802098

Get Book

Drying Technologies for Biotechnology and Pharmaceutical Applications by Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros Pdf

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.

Handbook of Stability Testing in Pharmaceutical Development

Kim Huynh-Ba
Handbook of Stability Testing in Pharmaceutical Development Book PDF

Author : Kim Huynh-Ba
Publisher : Springer Science & Business Media
Page : 389 pages
File Size : 42,8 Mb
Release : 2008-11-16
Category : Medical
ISBN : 9780387856278

Get Book

Handbook of Stability Testing in Pharmaceutical Development by Kim Huynh-Ba Pdf

This handbook is the first to cover all aspects of stability testing in pharmaceutical development. Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.

Ice Templating and Freeze-Drying for Porous Materials and Their Applications

Haifei Zhang
Ice Templating and Freeze Drying for Porous Materials and Their Applications Book PDF

Author : Haifei Zhang
Publisher : John Wiley & Sons
Page : 376 pages
File Size : 52,9 Mb
Release : 2018-10-22
Category : Science
ISBN : 9783527342723

Get Book

Ice Templating and Freeze-Drying for Porous Materials and Their Applications by Haifei Zhang Pdf

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.

Pharmaceutical Inhalation Aerosol Technology, Third Edition

Anthony J. Hickey,Sandro R. da Rocha
Pharmaceutical Inhalation Aerosol Technology Third Edition Book PDF

Author : Anthony J. Hickey,Sandro R. da Rocha
Publisher : CRC Press
Page : 784 pages
File Size : 51,5 Mb
Release : 2019-03-26
Category : Medical
ISBN : 9780429619564

Get Book

Pharmaceutical Inhalation Aerosol Technology, Third Edition by Anthony J. Hickey,Sandro R. da Rocha Pdf

This fully revised and updated third edition of Pharmaceutical Inhalation Aerosol Technology encompasses the scientific and technical foundation for the rationale, design, componentry, assembly and quality performance metrics of therapeutic inhalers in their delivery of pharmaceutical aerosols to treat symptoms or the underlying causes of disease. It focuses on the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery. The expanded scope considers previously unaddressed aspects of pharmaceutical inhalation aerosol technology and the patient interface by including aerosol delivery, lung deposition and clearance that are used as measures of effective dose delivery. Key Features: Provides a thoroughly revised and expanded reference with authoritative discussions on the physiologic,pharmacologic, metabolic, molecular, cellular and physicochemical factors, influencing the efficacy and utilization of pharmaceutical aerosols Emphasizes the importance of pharmaceutical engineering as a foundational element of all inhaler products and their application to pulmonary drug delivery Addresses the physics, chemistry and engineering principles while establishing disease relevance Expands the ‘technology’ focus of the original volumes to address the title more directly Offers an impressive breadth of coverage as well as an international flavour from outstanding editors and contributors

Freeze Drying of Pharmaceutical Products

Davide Fissore,Roberto Pisano,Antonello Barresi
Freeze Drying of Pharmaceutical Products Book PDF

Author : Davide Fissore,Roberto Pisano,Antonello Barresi
Publisher : CRC Press
Page : 201 pages
File Size : 45,6 Mb
Release : 2019-10-24
Category : Medical
ISBN : 9780429664014

Get Book

Freeze Drying of Pharmaceutical Products by Davide Fissore,Roberto Pisano,Antonello Barresi Pdf

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.

Development of Biopharmaceutical Drug-Device Products

Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Development of Biopharmaceutical Drug Device Products Book PDF

Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publisher : Springer Nature
Page : 888 pages
File Size : 48,8 Mb
Release : 2020-03-13
Category : Medical
ISBN : 9783030314156

Get Book

Development of Biopharmaceutical Drug-Device Products by Feroz Jameel,John W. Skoug,Robert R. Nesbitt Pdf

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.