The Challenge of CMC Regulatory Compliance for Biopharmaceuticals, Geigert John

Автор: Geigert
Название: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
ISBN: 3030137538 ISBN-13(EAN): 9783030137533
Издательство: Springer
Рейтинг:
Цена: 149060.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:

Complexity of Biologics CMC Regulation.- Biopharmaceutics are Not Chemical Drugs.- An Effective CMC Strategy is Possible.- Challenge of Adventitious Agent Control.- Biopharmaceutical Source Materials.- Manufacturing of Biopharmaceutical APIs.- Manufacturing of the Drug Product.- Complex Process-Related Impurity Profiles.- Product Characterization is a Journey.- Priceless Potency (Therapeutic Activity).- Quality Attributes of a Biopharmaceutical.- Designing the Stability Program.- The Art of Setting Specifications.- Demonstrating Product Comparability After Process Changes.- Invaluable CMC-Focused Meetings with Regulatory Authorities.

Автор: Jos? das Neves; Bruno Sarmento
Название: Mucosal Delivery of Biopharmaceuticals
ISBN: 1489978380 ISBN-13(EAN): 9781489978387
Издательство: Springer
Рейтинг:
Цена: 156720.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
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: Vladimir I. Razinkov
Название: High Throughput Formulation Development of Biopharmaceuticals
ISBN: 1907568638 ISBN-13(EAN): 9781907568633
Издательство: Elsevier Science
Рейтинг:
Цена: 162820.00 T
Наличие на складе: Поставка под заказ.
Описание: High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary.

Автор: John Geigert
Название: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
ISBN: 1461348048 ISBN-13(EAN): 9781461348047
Издательство: Springer
Рейтинг:
Цена: 186330.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed.

Автор: Wolf Moritz, Bielser Jean-Marc, Morbidelli Massimo
Название: Perfusion Cell Culture Processes for Biopharmaceuticals: Process Development, Design, and Scale-Up
ISBN: 1108480039 ISBN-13(EAN): 9781108480031
Издательство: Cambridge University Press
Рейтинг:
Цена: 177170.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: Master the design and operation of perfusion cell cultures with this authoritative reference. A perfect resource for groups active in the cell culture field, as well as graduate students in areas such as chemical engineering, biotechnology, chemistry and biology.

Автор: David Aebisher
Название: An Essential Guide to Biopharmaceuticals
ISBN: 1536181781 ISBN-13(EAN): 9781536181784
Издательство: Nova Science
Рейтинг:
Цена: 149940.00 T
Наличие на складе: Невозможна поставка.
Описание: This book provides a current review of the field of biopharmaceutical pharmacology. Biopharmaceuticals are drugs obtained in biotechnological processes using living organisms such as bacteria and fungi. An analysis was performed from biochemical and physiological point of view. This book covers an essential guide to current knowledge and analysis of biopharmaceuticals (Chapter 1-5). The composition of the biopharmaceuticals is provided. In this book we also discuss the historical point of view of the use of archeological botany, medicinal plants, strategies and main advances in communication between the nature and the advances of biopharmacy (Chapter 6-8). This book reports results from experimental and clinical work (Chapter 9). The book includes data regarding the therapy in combination with chemotherapeutic agents.

Автор: Houde, Damian J.
Название: Biophysical Characterization Of Proteins In Developing Biopharmaceuticals
ISBN: 0444641734 ISBN-13(EAN): 9780444641731
Издательство: Elsevier Science
Рейтинг:
Цена: 218960.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание:

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today's industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals.

Автор: Beck Alain
Название: Glycosylation Engineering of Biopharmaceuticals
ISBN: 1627033262 ISBN-13(EAN): 9781627033268
Издательство: Springer
Рейтинг:
Цена: 158380.00 T
Наличие на складе: Есть у поставщика Поставка под заказ.
Описание: This Methods in Molecular Biology(TM) book offers protocols for glycoproteins and glyco-engineered biopharmaceuticals with a focus on mAbs. Covers glyco-engineering of therapeutic proteins, glycoanalytics, glycoprotein complex characterization and PK/PD assays.