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 : 2023-08-25
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 2023-08-25 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
Sugar Based Surfactants For Pharmaceutical Protein Formulations
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Author : Lars Schiefelbein
language : en
Publisher: Cuvillier Verlag
Release Date : 2011-07-25
Sugar Based Surfactants For Pharmaceutical Protein Formulations written by Lars Schiefelbein and has been published by Cuvillier Verlag this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011-07-25 with Medical categories.
Nonionic Surfactants, Sugar-Based Surfactants, Alkylpolyglucosides, Protein Formulations
Fast Dynamic Surfactant Reduces Aggregation Of Biologics
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Author : Joshua S Katz
language : en
Publisher:
Release Date : 2017
Fast Dynamic Surfactant Reduces Aggregation Of Biologics written by Joshua S Katz and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2017 with categories.
As the pharmaceutical industry shifts from small molecule drug to biologic drug development, new and unique formulation needs emerge. Issues relating to shelf-stability of biologic formulations remain a key challenge to new drug development for both the developed and developing world. N-myristoyl phenylalanine Jeffamine M1000 diamide (FM1000) is a new experimental surfactant that has been developed for stabilizing biopharmaceuticals. FM1000 exhibits an order of magnitude faster interfacial dynamics than conventional formulation excipients, leading to improved agitation stability. A three-fold drop in IgG aggregation rate was observed for IgG formulated with FM1000 compared to control surfactant formulations. In a study of abatacept aggregation, FM1000 minimized the monomer loss both in glass vials and in IV bags, even out-performing Poloxamer 188, the incumbent technology. FM1000 also reduced subvisible particle formation in a cetuximab model formulation. Coupling aggregation performance with fundamental surfactant interfacial dynamics and behavior will help better understand the underlying mechanisms of protein (de)stabilization, enabling the development of higher stability formulations.
Sugar Based Surfactants For Pharmaceutical Protein Formulations
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Author : Lars Kurt Johann Schiefelbein
language : en
Publisher:
Release Date : 2011
Sugar Based Surfactants For Pharmaceutical Protein Formulations written by Lars Kurt Johann Schiefelbein and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2011 with categories.
Biopharmaceutics Applications In Drug Development
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Author : Rajesh Krishna
language : en
Publisher: Springer Science & Business Media
Release Date : 2007-09-20
Biopharmaceutics Applications In Drug Development written by Rajesh Krishna 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 2007-09-20 with Medical categories.
The highly experienced authors here present readers with step-wise, detail-conscious information to develop quality pharmaceuticals. The book is made up of carefully crafted sections introducing key concepts and advances in the areas of dissolution, BA/BE, BCS, IVIC, and product quality. It provides a specific focus on the integration of regulatory considerations and includes case histories highlighting the biopharmaceutics strategies adopted in development of successful drugs.
Discovering And Developing Molecules With Optimal Drug Like Properties
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Author : Allen C Templeton
language : en
Publisher: Springer
Release Date : 2014-10-31
Discovering And Developing Molecules With Optimal Drug Like Properties written by Allen C Templeton and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2014-10-31 with Medical categories.
This authoritative volume provides a contemporary view on the latest research in molecules with optimal drug-like properties. It is a valuable source to access current best practices as well as new research techniques and strategies. Written by leading scientists in their fields, the text consists of fourteen chapters with an underlying theme of early collaborative opportunities between pharmaceutical and discovery sciences. The book explores the practical realities of performing physical pharmaceutical and biopharmaceutical research in the context of drug discovery with short timelines and low compound availability. Chapters cover strategies and tactics to enable discovery as well as predictive approaches to establish, understand and communicate risks in early development. It also examines the detection, characterization, and assessment of risks on the solid state properties of advanced discovery and early development candidates, highlighting the link between solid state properties and critical development parameters such as solubility and stability. Final chapters center on techniques to improve molecular solubilization and prevent precipitation, with particularly emphasis on linking physiochemical properties of molecules to formulation selection in preclinical and clinical settings.
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.
Development And Manufacture Of Protein Pharmaceuticals
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Author : Steve L. Nail
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-12-06
Development And Manufacture Of Protein Pharmaceuticals written by Steve L. Nail 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.
In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.
Recent Developments In The Technology Of Surfactants
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Author : M.R. Porter
language : en
Publisher:
Release Date : 1990-10-31
Recent Developments In The Technology Of Surfactants written by M.R. Porter and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1990-10-31 with Science categories.
Excipient Development For Pharmaceutical Biotechnology And Drug Delivery Systems
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Author : Ashok Katdare
language : en
Publisher: CRC Press
Release Date : 2006-07-28
Excipient Development For Pharmaceutical Biotechnology And Drug Delivery Systems written by Ashok Katdare and has been published by CRC Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2006-07-28 with Medical categories.
To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new, yet to be developed, and approved excipients continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge potential new avenues for regulatory approval. This book presents detailed, up-to-date information on various aspects of excipient development, testing, and technological considerations for their use. It addresses specific details such as historical perspective, preclinical testing, safety, and toxicology evaluation, as well as regulatory, quality, and utility aspects. The text also describes best practices for use of various functional excipients and extensive literature references for all topics.