Mucosal Delivery of Drugs and Biologics in Nanoparticles, Muttil Pavan, Kunda Nitesh K.

Автор: Weichang Zhou; Anne Kantardjieff
Название: Mammalian Cell Cultures for Biologics Manufacturing
ISBN: 3662522705 ISBN-13(EAN): 9783662522707
Издательство: Springer
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Описание: Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. The series also discusses new discoveries and applications. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification. In general, special volumes are edited by well-known guest editors. The series editor and publisher will however always be pleased to receive suggestions and supplementary information. Manuscripts are accepted in English.

Автор: Dushyant Varshney; Manmohan Singh
Название: Lyophilized Biologics and Vaccines
ISBN: 149392382X ISBN-13(EAN): 9781493923823
Издательство: Springer
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Цена: 22359.00 р.
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Описание:

Preface.- Part I - Lyophilization History and Fundamentals.- History of Lyophilization.- Heterogeneity of protein environments in frozen solutions and in the dried state.- Advance understanding of buffer behavior during lyophilization.- Advances in Instrumental Analysis Applied to the Development of Lyophilization Cycles.- New Developments in Controlled Nucleation: Commercializing VERISEQ^(R) Nucleation technology.- Part II - Lyophilized Biologics and Vaccines - Modality Considerations.- Lyophilized Biologics.- Lyophilization of Therapeutic Proteins in Vials - Process Scale-up and Advances in Quality by Design.- Advances in Process Analytical Technology in Freeze Drying.- Process Scale-up and Optimization of Lyophilized Vaccine Products.- Stabilization of Plasmid DNA and Lipid-based Therapeutics as Dehydrated Formulations.- Part III - Advances in Alternate Drying.- Alternatives to Vial Lyophilization.- Spray Drying of Biopharmaceuticals.- Current Trends and Advances in Bulk Crystallization and Freeze Drying of Biopharmaceuticals.- Case Studies and Examples of Biopharmaceutical Modalities.- Processed by Bulk Crystallization or Bulk Freeze Drying.- Part IV- Regulatory, Packaging and Technology Transfer Considerations.- Lyophilization of Biologics - An FDA Perspective.- Recent Trends in Lyophilized Delivery Devices and Packaging.- Lyophilization Technology Transfer towards Product Launch.

Автор: Weichang Zhou; Anne Kantardjieff
Название: Mammalian Cell Cultures for Biologics Manufacturing
ISBN: 364254049X ISBN-13(EAN): 9783642540493
Издательство: Springer
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Цена: 39130.00 р.
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Описание: Volumes are organized topically and provide a comprehensive discussion of developments in the respective field over the past 3-5 years. Special volumes are dedicated to selected topics which focus on new biotechnological products and new processes for their synthesis and purification.

Автор: Brian R. Moyer; Narayan P.S. Cheruvu; Tom C.-C. Hu
Название: Pharmaco-Imaging in Drug and Biologics Development
ISBN: 1461482461 ISBN-13(EAN): 9781461482468
Издательство: Springer
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Цена: 23757.00 р.
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Описание: The volume aim to be a comprehensive overview of the drug and biologic development process that is often called "the valley of death" (pre-IND through approval) where high costs of studies and high rates of product failure are part of the drug development landscape.

Автор: Dushyant Varshney; Manmohan Singh
Название: Lyophilized Biologics and Vaccines
ISBN: 1493955683 ISBN-13(EAN): 9781493955688
Издательство: Springer
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Цена: 16070.00 р.
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Описание: 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.

Автор: Sarfaraz K. Niazi
Название: Biosimilars and Interchangeable Biologics: Strategic Elements
ISBN: 1138775509 ISBN-13(EAN): 9781138775503
Издательство: Taylor&Francis
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Цена: 16078.00 р.
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Описание:

What's the Deal with Biosimilars?

Biosimilars are gaining momentum as new protein therapeutic candidates that can help fill a vital need in the healthcare industry. The biological drugs are produced by recombinant DNA technology that allows for large-scale production and an overall reduction time in costs and development.

Part of a two-volume set that covers varying aspects of biosimilars, Biosimilars and Interchangeable Biologics: Strategic Elements explores the strategic planning side of biosimilar drugs and targets issues surrounding biosimilars that are linked to legal matters. This includes principal patents and intellectual property, regulatory pathways, and concerns about affordability on a global scale. It addresses the complexity of biosimilar products, and it discusses the utilization of biosimilars and related biological drugs in expanding world markets.

Of specific interest to practitioners, researchers, and scientists in the biopharmaceutical industry, this volume examines the science, technology, finance, legality, ethics, and politics of biosimilar drugs. It considers strategic planning elements that include an overall understanding of the history and the current status of the art and science of biosimilars, and it provides detailed descriptions of the legal, regulatory, and commercial characteristics. The book also presents a global strategy on how to build, take to market, and manage the next generation of biosimilars throughout their life cycle.

Название: Compliance handbook for pharmaceuticals, medical devices, and biologics
ISBN: 0367394766 ISBN-13(EAN): 9780367394769
Издательство: Taylor&Francis
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Цена: 9798.00 р.
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Описание: Richard Garfield`s `Carnival Of Monsters` is being revamped by VR in 2019! The carnival is coming, ready to amaze with unusual creatures never seen before! As the master of your very own Carnival of Monsters, can you present the audience with the spectacle they demand by capturing the most magnificent menagerie of monsters? The carnival master who can explore the magical lands where these creatures dwell and bring back the finest specimens will know riches and fame galore. But be careful-not all monsters are peaceful, so keep a few hunters on hand to keep them from getting loose! Richard Garfield`s Carnival of Monsters is a card-drafting and set-collecting game for 2 to 5 players, ages 10 and up. In this approximately 45-minute game, players draft cards from their hands, trying to collect sets of matching lands so they can capture and display exotic creatures to earn victory points. Along the way, they can hire talented staff to aid their efforts, pursue their own secret goals, or take advantage of fortuitous events. At the end of each season, they must make sure that none of their monsters escape, while the player who can best meet the demands of the audience will be awarded with a bonus!

Автор: Michael J. Rathbone; Sevda Senel; Indiran Pather
Название: Oral Mucosal Drug Delivery and Therapy
ISBN: 1489978410 ISBN-13(EAN): 9781489978417
Издательство: Springer
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Цена: 18284.00 р.
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Описание:

.- 1 Anatomy and Physiology of the Oral Mucosa

.- 2 Design and Development of Oral Mucosal Drug Delivery Systems

.- 3 Chemical Methods for Enhancing Oral Mucosal Delivery

.- 4 Mucoadhesive Polymers as Enabling Excipients for Oral Mucosal Drug Delivery

.- 5 Physical Methods for Enhancing Oral Mucosal Delivery: Sonophoresis, Iontophoresis and Electroporation

.- 6 Characterization Methods for Oral Mucosal Drug Delivery

.- 7 Design and Development of Systemic Oral Mucosal Drug Delivery Systems

.- 8 Tablets and Other Solid Dosage Forms for Systemic Oral Mucosal Drug Delivery

.- 9 Formulation of Delivery Systems for Photosensitisers Used in Oral Cavity Photodynamic Therapy

.- 10 Medical devices for Oral Mucosal Applications

.- 11 Pharmaceuticals for Oral Mucosal Drug Delivery: Regulatory Considerations.

Автор: Michael J. Rathbone; Sevda Senel; Indiran Pather
Название: Oral Mucosal Drug Delivery and Therapy
ISBN: 1489975578 ISBN-13(EAN): 9781489975577
Издательство: Springer
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Цена: 20896.00 р.
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Описание: Oral Mucosal Drug Delivery and Therapy

Автор: Yashwant V Pathak
Название: Surface Modification of Nanoparticles for Targeted Drug Delivery
ISBN: 3030061140 ISBN-13(EAN): 9783030061142
Издательство: Springer
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Цена: 6986.00 р.
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Описание: This unique book is the only one to discuss various new techniques developed to enhance the application of nanoparticulate drug delivery systems using surface modification of nanoparticles. The understanding of the surface characteristics nano-particles is growing significantly with the advent of new analytical techniques. Polymer chemistry is contributing to the development of many new versatile polymers which have abilities to accommodate many different, very reactive chemical groups, and can be used as a diagnostic tool, for better targeting, for more effective therapeutic results as well as for reducing the toxic and side effects of the drugs. Surface modification of such polymeric nanoparticles has been found by many scientists to enhance the application of nanoparticles and also allows the nano particles to carry specific drug molecule and disease /tumor specific antibodies which refine and improve drug delivery. Surface Modification of Nanoparticles for Targeted Drug Delivery is a collection essential information with various applications of surface modification of nanoparticles and their disease specific applications for therapeutic purposes.

Автор: Jos? das Neves; Bruno Sarmento
Название: Mucosal Delivery of Biopharmaceuticals
ISBN: 1489978380 ISBN-13(EAN): 9781489978387
Издательство: Springer
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Цена: 23508.00 р.
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Описание:

.-1. Concepts in Mucosal Immunity and Mucosal Vaccines
.-Simona Gallorini, Derek T. O'Hagan, Barbara C. Baudner

.-2. Mucoadhesion and Characterization of Mucoadhesive Properties
.-Tao Yu, Gavin P. Andrews, David S. Jones

.-3. Mucus as a Barrier for Biopharmaceuticals and Drug Delivery Systems
.-Hongbo Zhang, Mohammed-Ali Shahbazi, Patrick Almeida, Hйlder A. Santos

.-4. Epithelial Permeation and Absorption Mechanisms of Biopharmaceuticals
.-Hanne M rck Nielsen

.-5. Oral Delivery of Biopharmaceuticals
.-Catarina Oliveira Silva, Bruno Sarmento, Catarina Pinto Reis

.-6. Buccal Delivery of Biopharmaceuticals: Vaccines and Allergens
.-Sevda Şenel, Merve Cansız, Michael J. Rathbone

.-7. Pulmonary Delivery of Biopharmaceuticals
.-Fernanda Andrade, Catarina Moura, Bruno Sarmento

.-8. Nasal Delivery of Biopharmaceuticals
.-Eiji Yuba, Kenji Kono

.-9. Ocular Delivery of Biopharmaceuticals
.-Holly Lorentz, Heather Sheardown

.-10. Vaginal Delivery of Biopharmaceuticals
.-Josй das Neves

.-11. Nanoparticles-in-Microsphere Oral Delivery Systems (NiMOS) for Nucleic Acid Therapy in the Gastrointestinal Tract
.-Shardool Jain, Mansoor Amiji

.-12. Bacteria-Based Vectors for Oral Gene Therapy
.-Yong Bai, Rachael Burchfield, Sangwei Lu, Fenyong Liu

.-13. Self-Assembled Polysaccharide Nanogels for Nasal Delivery of Biopharmaceuticals
.-Tomonori Nochi, Yoshikazu Yuki, Kazunari Akiyoshi, Hiroshi Kiyono

.-14. Pheroid(TM) Vesicles and Microsponges for Nasal Delivery of Biopharmaceuticals
.-Lissinda H. du Plessis, Awie F. Kotzй

.-15. Delivery Strategies for Developing siRNA-Based Vaginal Microbicides
.-Joseph A Katakowski, Deborah Palliser

.-16. Delivery Strategies for Developing Vaginal DNA Vaccine Combining Cell-Penetrating Peptides and Jet Injection
.-Takanori Kanazawa, Hiroaki Okada

.-17. Vaccine Delivery Systems for Veterinary Immunization
.-Juan M. Irache, Ana I. Camacho, Carlos Gamazo

.-18. Eligen(R) Technology for Oral Delivery of Proteins and Peptides
.-Sunita Prem Victor, Willi Paul, and Chandra P. Sharma

.-19. The RapidMist(TM) System for Buccal Delivery of Insulin
.-Meena Bansal, Sanjay Bansal, Rachna Kumria

.-20. The Pharmaceutical Development of rhDNase (Dornase Alpha) for the Treatment of Cystic Fibrosis
.-Steven J. Shire, Thomas M. Scherer

.-21. Development of the Exubera(R) Insulin Pulmonary Delivery System
.-Cynthia L. Stevenson, David Bennett

.-22. Technosphere(R) An Inhalation System for Pulmonary Delivery of Biopharmaceuticals
.-Antуnio J. Almeida, Ana Grenha

.-23. ChiSys(R) as a Chitosan-Based Delivery Platform for Nasal Vaccination
.-Peter Watts, Alan Smith, Michael Hinchcliffe

.-24. Development of a Cationic Nanoemulsion Platform (Novasorb(R)) for Ocular Delivery
.-Frйdйric Lallemand, Philippe Daull, Jean-Sйbastien Garrigue

.-25. Regulatory Aspects and Approval of Biopharmaceuticals for Mucosal Delivery: Quality, Toxicology and Clinical Aspects
.-Karen Brigitta Goetz, Yuansheng Sun, Katrin Fйchir, Evelyne Kretzschmar, Isabel Buettel

Автор: Jos? das Neves; Bruno Sarmento
Название: Mucosal Delivery of Biopharmaceuticals
ISBN: 1461495237 ISBN-13(EAN): 9781461495239
Издательство: Springer
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Цена: 27950.00 р.
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Описание: Mucosal Delivery of Biopharmaceuticals