Surfactants In Biopharmaceutical Development

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Surfactants In Biopharmaceutical Development

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Author : Atanas V. Koulov
language : en
Publisher: Academic Press
Release Date : 2023-08-12

Surfactants In Biopharmaceutical Development written by Atanas V. Koulov and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2023-08-12 with Medical categories.

Surfactants in Biopharmaceutical Development addresses the progress, challenges and opportunities for surfactant research specific to pharmaceutical development, providing a broad range of important surfactant-related topics as they relate directly to the biopharmaceutical process. Chapters address fundamental topics, like mechanisms of protein stabilization by surfactants, the latest, state-of-the-art technology and methods to illustrate the practical application to biopharmaceutical development, forward-looking chapters on control strategies and novel surfactants, with a special focus on current regulatory aspects of paramount importance for biopharmaceutical companies and regulators. It has been widely recognized that surfactants provide protection to therapeutic proteins against interfacial stresses. Despite the fact that the very mechanism of protein stabilization by surfactants has not been completely understood, surfactants are universally regarded as critical functional excipients by the industry and by regulators. - Describes the current state of research on surfactants in the context of biopharmaceutical development, drawing upon contributions from international experts across industry, academia, and regulators - Addresses the opportunities and challenges associated with surfactants in biologic drug development - Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics by summarizing the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume

Issues In Pharmacology Pharmacy Drug Research And Drug Innovation 2011 Edition

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Author :
language : en
Publisher: ScholarlyEditions
Release Date : 2012-01-09

Issues In Pharmacology Pharmacy Drug Research And Drug Innovation 2011 Edition written by and has been published by ScholarlyEditions this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-01-09 with Medical categories.

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition is a ScholarlyEditions™ eBook that delivers timely, authoritative, and comprehensive information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation. The editors have built Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Pharmacology, Pharmacy, Drug Research, and Drug Innovation in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Challenges In Protein Product Development

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Author : Nicholas W. Warne
language : en
Publisher: Springer
Release Date : 2018-06-20

Challenges In Protein Product Development written by Nicholas W. Warne and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2018-06-20 with Medical categories.

In this volume, the authors discuss the many significant challenges currently faced in biotechnology dosage form development, providing guidance, shared experience and thoughtful reflection on how best to address these potential concerns. As the field of therapeutic recombinant therapeutic proteins enters its fourth decade and the market for biopharmaceuticals becomes increasingly competitive, companies are increasingly dedicating resources to develop innovative biopharmaceuticals to address unmet medical needs. Often, the pharmaceutical development scientist is encountering challenging pharmaceutical properties of a given protein or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Quality By Design For Biopharmaceutical Drug Product Development

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Author : Feroz Jameel
language : en
Publisher: Springer
Release Date : 2015-04-01

Quality By Design For Biopharmaceutical Drug Product Development written by Feroz Jameel and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-04-01 with Medical categories.

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.

Preclinical Development Handbook

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Author : Shayne Cox Gad
language : en
Publisher: John Wiley & Sons
Release Date : 2008-03-21

Preclinical Development Handbook written by Shayne Cox Gad and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-03-21 with Medical categories.

A clear, straightforward resource to guide you through preclinical drug development Following this book's step-by-step guidance, you can successfully initiate and complete critical phases of preclinical drug development. The book serves as a basic, comprehensive reference to prioritizing and optimizing leads, dose formulation, ADME, pharmacokinetics, modeling, and regulations. This authoritative, easy-to-use resource covers all the issues that need to be considered and provides detailed instructions for current methods and techniques. Each chapter is written by one or more leading experts in the field. These authors, representing the many disciplines involved in preclinical toxicology screening and testing, give you the tools needed to apply an effective multidisciplinary approach. The editor has carefully reviewed all the chapters to ensure that each one is thorough, accurate, and clear. Among the key topics covered are: * Modeling and informatics in drug design * Bioanalytical chemistry * Absorption of drugs after oral administration * Transporter interactions in the ADME pathway of drugs * Metabolism kinetics * Mechanisms and consequences of drug-drug interactions Each chapter offers a full exploration of problems that may be encountered and their solutions. The authors also set forth the limitations of various methods and techniques used in determining the safety and efficacy of a drug during the preclinical stage. This publication should be readily accessible to all pharmaceutical scientists involved in preclinical testing, enabling them to perform and document preclinical safety tests to meet all FDA requirements before clinical trials may begin.

Microbial Surfactants In Pharmaceuticals And Cosmetics

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Author : R.Z. Sayyed
language : en
Publisher: CRC Press
Release Date : 2025-02-28

Microbial Surfactants In Pharmaceuticals And Cosmetics written by R.Z. Sayyed and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2025-02-28 with Business & Economics categories.

Biosurfactants and bioemulsifiers are considered green molecules as they are produced from microbes and are easily degradable as compared to surfactants. They are suitable due to properties such as low toxicity, tolerance to a wide-range pH level and temperature, high surface activity, biodegradability, excellent emulsifying and demulsifying ability. While, caution and care should be exercised in its widespread usage, they are likely to replace chemical surfactants. The book focuses on biosurfactant production from various bacteria, diversity of biosurfactant producing bacteria, and the industrial need of biosurfactants. Fields such as pharmacy, medicine, and cosmetics are covered. It is presented in an easy-to-understand manner, and is well illustrated, and comprises protocols and recent data on the production, formulation and commercialization and other aspects of biosurfactants and bioemulsifiers.

Rational Design Of Stable Protein Formulations

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Author : John F. Carpenter
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06

Rational Design Of Stable Protein Formulations written by John F. Carpenter and has been published by Springer Science & Business Media this book supported file pdf, txt, epub, kindle and other format this book has been release on 2012-12-06 with Medical categories.

Recombinant proteins and polypeptides continue to be the most important class of biotechnology-derived agents in today's pharmaceutical industry. Over the past few years, our fundamental understanding of how proteins degrade and how stabilizing agents work has made it possible to approach formulation of protein pharmaceuticals from a much more rational point of view. This book describes the current level of understanding of protein instability and the strategies for stabilizing proteins under a variety of stressful conditions.

Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals

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Author : Feroz Jameel
language : en
Publisher: John Wiley & Sons
Release Date : 2010-08-09

Formulation And Process Development Strategies For Manufacturing Biopharmaceuticals written by Feroz Jameel and has been published by John Wiley & Sons this book supported file pdf, txt, epub, kindle and other format this book has been release on 2010-08-09 with Science categories.

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase–appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Biophysical Characterization Of Proteins In Developing Biopharmaceuticals

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Author : Damian J. Houde
language : en
Publisher: Elsevier
Release Date : 2019-11-13

Biophysical Characterization Of Proteins In Developing Biopharmaceuticals written by Damian J. Houde and has been published by Elsevier this book supported file pdf, txt, epub, kindle and other format this book has been release on 2019-11-13 with Medical categories.

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. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical's developability and the technical decision-making process needed when dealing with biophysical characterization data. - Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development - Highlights the capabilities and limitations of each technique - Discusses the underlining science of each tool - Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools - Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Handbook Of Detergents 6 Volume Set

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Author : Uri Zoller
language : en
Publisher: CRC Press
Release Date : 2008-11-23

Handbook Of Detergents 6 Volume Set written by Uri Zoller and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2008-11-23 with Science categories.

With contributions from experts and pioneers, this set provides readers with the tools they need to answer the need for sustainable development faced by the industry. The six volumes constitute a shift from the traditional, mostly theoretical focus of most resources to the practical application of advances in research and development. With con