Surfactants In Biopharmaceutical Development

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

Nonionic Surfactants, Sugar-Based Surfactants, Alkylpolyglucosides, Protein Formulations

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.

Surfactants play an essential role in our daily lives. Their form of usage varies from detergents and cleaning agents through disinfectants and solubilisers up to industrial applications such as paints, oil recovery, anti-corrosion protective coatings, etc. A special distinct class of surfactants is represented by a double-chain, double-head form of surfactant molecules, which are called gemini surfactants. Gemini surfactants show physicochemical and aggregation properties which are superior to those of conventional, single-chain surfactants. From the perspective of applications, an important group of gemini surfactants is represented by cationic gemini surfactants. They have found numerous applications in the various fields such as solubilisation, textile coating, organic and polymer synthesis, electrochemistry, paper industry, etc. One of the most developing areas of cationic gemini surfactants application is the field of pharmaceutical applications. Interaction of cationic surfactants with the oppositely charged cell membrane has been known for a long time. Cationic gemini surfactants turned out to be very efficient bactericidal and antimicrobial agents. Moreover, recent development in this field indicates a cancerostatic effect of cationic geminis through a selective interaction of cationic gemini molecules with cancer cells. Another revolutionary field of cationic gemini surfactants application is their interaction with an oppositely charged electrolyte such as DNA. The interaction of DNA with various positively charged systems such as cationic surfactants, polymers and lipids is of great importance with respect to gene transmission through a biological cell membrane to achieve a therapeutic effect in a cell nucleus. The ambition of this monograph is to provide a complex view of synthesis, structure-aggregation, properties-biological activity relationship and recent applications of cationic gemini surfactants in the pharmaceutical field. Individual chapters in the monograph discuss the synthetic preparation of cationic surfactants, the effect of the structure of these compounds on their physical and physicochemical properties, particularly their aggregation properties and associated phenomena. A significant part of this publication is devoted to gemini surfactants, a relatively new class of surfactants whose special and surprising properties increasingly continue to draw the attention of the research community. The final part of the monograph is oriented on the use of cationic surfactants in biomedicine and pharmaceutical applications, where a special emphasis is put on their antimicrobial and antineoplastic activities. Finally, cationic surfactants as potent non-viral gene delivery vehicles are analysed and evaluated. The monograph is intended to serve as a guide for scientists and students in the field of pharmaceutical research and chemistry of colloids and surfactants.

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.