Surfactants in Biopharmaceutical Development

Surfactants in Biopharmaceutical Development PDF

Author: Atanas V. Koulov

Publisher: Academic Press

Published: 2023-08-25

Total Pages: 236

ISBN-13: 0128125691

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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

Surfactant Systems

Surfactant Systems PDF

Author: D. Attwood

Publisher: Springer Science & Business Media

Published: 2012-12-06

Total Pages: 802

ISBN-13: 9400957750

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It is now twelve years since Solubilization by Surface-Active Agents appeared. Since the publication of that monograph the subject has expanded rapidly as the unique potential of surfactants has become known to a wider circle of scientists. In a recent review Menger (Accounts of Chemical Research, 12 (1979) 111) estimated that since 1970 there have been over 2800 publications on micelles and micellization alone. The topic of catalysis in micellar media was in an early stage of development in 1968 but the growth in this subject has given rise to an excellent textbook by Fendler and Fendler. We have felt for some time that a revision of Solubilization by Surface-Active Agents was overdue. The book has been out of print for some time. Owing to pressure of other work, Professor P. H. Elworthy and Dr C. B. Macfarlane were unable to undertake the work of revision but while working together on an undergraduate textbook the present authors decided to set to work, realizing both the impossibility of producing a comprehensive textbook and the need to alter the scope of the book. Micellar solubilization occurs over a relatively small surfactant concentration range; because of this and because the phenomenon is never observed in isolation, we have extended the text to include surface activity, emulsions and suspensions and, as our emphasis is on formulation of medicinal products, to the of the toxicology of surface-active agents.

Fast Dynamic Surfactant Reduces Aggregation of Biologics

Fast Dynamic Surfactant Reduces Aggregation of Biologics PDF

Author: Joshua S Katz

Publisher:

Published: 2017

Total Pages:

ISBN-13:

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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.

Biopharmaceutics Applications in Drug Development

Biopharmaceutics Applications in Drug Development PDF

Author: Rajesh Krishna

Publisher: Springer Science & Business Media

Published: 2007-09-20

Total Pages: 416

ISBN-13: 038772379X

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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.

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition

Issues in Pharmacology, Pharmacy, Drug Research, and Drug Innovation: 2011 Edition PDF

Author:

Publisher: ScholarlyEditions

Published: 2012-01-09

Total Pages: 4229

ISBN-13: 1464963428

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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

Challenges in Protein Product Development PDF

Author: Nicholas W. Warne

Publisher: Springer

Published: 2018-06-20

Total Pages: 599

ISBN-13: 3319906038

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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.

New and Future Developments in Microbial Biotechnology and Bioengineering

New and Future Developments in Microbial Biotechnology and Bioengineering PDF

Author: Alexandre Gomes Rodrigues

Publisher: Elsevier

Published: 2020-06-10

Total Pages: 376

ISBN-13: 0444643028

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New and Future Developments in Microbial Biotechnology and Bioengineering: Microbial Biomolecules: Properties, Relevance and Their Translational Applications presents a concise review on microbial biotechnology, along with impacts and recent results from research centers, small companies and large enterprises. The book brings the most relevant information on how we can use resources - in this case from microorganisms - and technology to develop solutions in fields like biofuels, food, cosmetics and medicine. It covers case studies of start-ups in the field and explains how scientists have moved their ideas into profitable bio-based products that are necessary for our current living standards. In addition, the book describes strategic governmental programs designed to exploit biomass in a sustainable way, along with detailed information on research in several high-impact, worldwide laboratories. It gives concrete examples of ongoing research from molecules to methods, such as L-asparaginase, extremophiles, new diagnostics tools and the analytical methods that have raised the quality of the data obtained, thereby boosting the so-called bioeconomy. Comprises a unique source of information on the various applications of microbial biomolecules Provides resourceful material for new ideas and strong rational/application-oriented stories Discusses biotech companies in various areas (biofuel, food, medicine, etc.) who are actively using microbial biomolecules Outlines scientific discoveries and their translation into profitable products Gives an insight perspective of institutional and governmental strategic research programs aiming to preserve, explore and generate benefits from microbial biomolecules

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