The Development Of Novel Excipients For The Stabilization Of Proteins Against Aggregation
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The Development Of Novel Excipients For The Stabilization Of Proteins Against Aggregation
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Author : Curtiss Paul Schneider
language : en
Publisher:
Release Date : 2011
The Development Of Novel Excipients For The Stabilization Of Proteins Against Aggregation written by Curtiss Paul Schneider 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.
Although protein based therapeutics is the fastest growing sector of the pharmaceutical industry, production costs remain incredibly high and rapid commercialization of new protein drug candidates are not being fully realized due to the presence of many barriers, namely the physical and chemical instabilities of proteins. Of these degradation pathways, protein aggregation is arguably the most common and troubling manifestation of protein instability, occurring in almost all phases of development. Protein aggregates are usually nonnative in structure, may exhibit reduced biological activity, and can remain soluble and/or precipitate from solution. In addition to reducing efficacy, if administered to a patient, aggregates can cause adverse reactions, such as immune response, sensitization, or even anaphylactic shock. Therefore, if even a small amount of aggregates form during formulation or storage, a product can be rendered unacceptable. Moreover, for the practical application of traditional and novel drug delivery techniques, protein based therapeutics must be formulated at relatively high concentrations and must remain stable for extended periods of time. The structural differences among various proteins are so significant, that the application of a universal stabilization strategy has not yet been successful, though the effects of common excipients are generally universal. The current approach toward stabilizing protein drugs against aggregation is by trial-and-error testing of different combinations of cosolutes (e.g. salts, sugars, surfactants, amino acids, etc.) using empirically derived heuristics. While ubiquitously used, this approach is inefficient and does not always enable the discovery of stable protein solution formulations. In response to this major problem, we have developed and tested a new class of excipients that has the potential for wide spread application as a universal stabilizer of protein therapeutics. When compared to other commonly used excipients, our novel excipients offer more than an order of magnitude improvement at suppressing the aggregation of a model protein. As a result, if used in formulations, the shelf life of a protein drug, at room or refrigerated temperatures, may be extended from a few weeks to several months or years. Furthermore, these excipients will likely be useful during production and purification for improving yield and lowering downstream purification costs.
Developing Novel Low Concentration Excipients To Suppress Protein Aggregation
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Author : Nikita Vekaria
language : en
Publisher:
Release Date : 2021
Developing Novel Low Concentration Excipients To Suppress Protein Aggregation written by Nikita Vekaria and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 2021 with categories.
Pharmaceutical Excipients
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Author : Otilia M. Y. Koo
language : en
Publisher: John Wiley & Sons
Release Date : 2016-10-03
Pharmaceutical Excipients written by Otilia M. Y. Koo 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 2016-10-03 with Medical categories.
This book provides an overview of excipients, their functionalities in pharmaceutical dosage forms, regulation, and selection for pharmaceutical products formulation. It includes development, characterization methodology, applications, and up-to-date advances through the perspectives of excipients developers, users, and regulatory experts. Covers the sources, characterization, and harmonization of excipients: essential information for optimal excipients selection in pharmaceutical development Describes the physico-chemical properties and biological effects of excipients Discusses chemical classes, safety and toxicity, and formulation Addresses recent efforts in the standardization and harmonization of excipients
Biological Drug Products
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Author : Wei Wang
language : en
Publisher: John Wiley & Sons
Release Date : 2013-08-29
Biological Drug Products written by Wei Wang 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 2013-08-29 with Medical categories.
Tested and proven solutions to the challenges of biological drug product development Biological drug products play a central role in combating human diseases; however, developing new successful biological drugs presents many challenges, including labor intensive production processes, tighter regulatory controls, and increased market competition. This book reviews the current state of the science, offering readers a single resource that sets forth the fundamentals as well as tested and proven development strategies for biological drugs. Moreover, the book prepares readers for the challenges that typically arise during drug development, offering straightforward solutions to improve their ability to pass through all the regulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with general considerations for the development of any biological drug product and then explores the strategies and challenges involved in the development of specific types of biologics. Divided into five parts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts in biological drug development. Contributions are based on a comprehensive review and analysis of the current literature as well as the authors' first-hand experience developing and testing new drugs. References at the end of each chapter serve as a gateway to original research papers and reviews in the field. By incorporating lessons learned and future directions for research, Biological Drug Products enables pharmaceutical scientists and students to improve their success rate in developing new biologics to treat a broad range of human diseases.
Advances And Avenues In The Development Of Novel Carriers For Bioactives And Biological Agents
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Author : Manju Rawat Singh
language : en
Publisher: Academic Press
Release Date : 2020-04-07
Advances And Avenues In The Development Of Novel Carriers For Bioactives And Biological Agents written by Manju Rawat Singh and has been published by Academic Press this book supported file pdf, txt, epub, kindle and other format this book has been release on 2020-04-07 with Business & Economics categories.
Advances and Avenues in the Development of Novel Carriers for Bioactives and Biological Agents provides sound data on the utility of biological and plant-based drugs and describes challenges faced in all aspects offering indispensable strategies to use in the development of bioactive medicines. Bioactive based medications are commonly used throughout the world and have been recognized by physicians and patients for their therapeutic efficacy. Bioactive formulations, including their subordinates and analogs, address 50% of all medicines in clinical practice. Novel bioactive medicine transporters can cure many disorders by both spatial and transitory approaches and have various justifications in medicinal potential. This book presents information on the utility of natural, plant, animal and bioengineered bioactive materials. It is a fundamental source of information and data for pharmacognosists, pharmaceutical analysts, drug transport scientists and pharmacologists working in bioactive medications. Advances information on various bioactive based medications, their sources, clinical consequences and transport strategies Illustrates diverse transport systems for bioactives and derivatives, novel techniques for formulations, targeting strategies and fundamental qualities of developed bioactive carriers, and their safety concerns and standardization Discusses distinctive transport systems, stability, upgraded dissolvability, and enhanced bioavailability of bioactives
Formulation And Delivery Of Proteins And Peptides
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Author : Jeffrey L. Cleland
language : en
Publisher:
Release Date : 1994
Formulation And Delivery Of Proteins And Peptides written by Jeffrey L. Cleland and has been published by this book supported file pdf, txt, epub, kindle and other format this book has been release on 1994 with Medical categories.
Presents an updated review of the recent research in formulation and delivery of proteins and peptides. Examines measurement and characterization of degradation products formed during storage, degradation mechanisms, and model systems designed to predict formulation stability. Discusses stabilization of proteins and peptides through lyophilization and focuses on the use of FTIR as a tool for understanding the role of excipients during lyophilization. Describes potential new routes and methods of delivery such as depot systems based on biodegradable polymers and aerosol systems for pulmonary delivery.
Drying Technologies For Biotechnology And Pharmaceutical Applications
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Author : Satoshi Ohtake
language : en
Publisher: John Wiley & Sons
Release Date : 2020-06-02
Drying Technologies For Biotechnology And Pharmaceutical Applications written by Satoshi Ohtake 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 2020-06-02 with Medical categories.
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.
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.
Development Of Novel Vaccines
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Author : Alexander von Gabain
language : en
Publisher: Springer Science & Business Media
Release Date : 2012-04-23
Development Of Novel Vaccines written by Alexander von Gabain 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 2012-04-23 with Medical categories.
“Development of novel vaccines” gives an overview of the tasks in basic research leading to the final product – the vaccine and its applications, belonging to the most complex biologics in the pharmaceutical field. Distinct from most textbooks in the vaccine arena, the current issue focuses on the translational aspect, namely, how research results can be transformed into life-saving medical interventions. Each chapter of the book deals with one important paradigm for the development of novel vaccines, along the value chain towards the final vaccine, and furthermore, with the inevitable tools required for this process. Contributions are prepared by teams of scientists, all of whom are experts in the field, most of them anchored in biomedical organizations devoted to translational culture, thereby lighting the certain topics from different views. This volume is a must read for researchers engaged in vaccine development and who really want to see their research results to become a product.
Excipient Applications In Formulation Design And Drug Delivery
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Author : Ajit S Narang
language : en
Publisher: Springer
Release Date : 2015-10-07
Excipient Applications In Formulation Design And Drug Delivery written by Ajit S Narang and has been published by Springer this book supported file pdf, txt, epub, kindle and other format this book has been release on 2015-10-07 with Medical categories.
In recent years, emerging trends in the design and development of drug products have indicated ever greater need for integrated characterization of excipients and in-depth understanding of their roles in drug delivery applications. This book presents a concise summary of relevant scientific and mechanistic information that can aid the use of excipients in formulation design and drug delivery applications. Each chapter is contributed by chosen experts in their respective fields, which affords truly in-depth perspective into a spectrum of excipient-focused topics. This book captures current subjects of interest – with the most up to date research updates – in the field of pharmaceutical excipients. This includes areas of interest to the biopharmaceutical industry users, students, educators, excipient manufacturers, and regulatory bodies alike.