Skip to main content

Surfactants In Biopharmaceutical Development

In Order to Read Online or Download Surfactants In Biopharmaceutical Development Full eBooks in PDF, EPUB, Tuebl and Mobi you need to create a Free account. Get any books you like and read everywhere you want. Fast Download Speed ~ Commercial & Ad Free. We cannot guarantee that every book is in the library!

Surfactants in Biopharmaceutical Development

Surfactants in Biopharmaceutical Development Book
Author : Atanas V. Koulov,Satish Singh
Publisher : Academic Press
Release : 2021-03-01
ISBN : 0128125691
Language : En, Es, Fr & De

GET BOOK

Book Description :

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, drawing upon contributions from international experts across industry and academia Addresses the opportunities and challenges associated with surfactants in drug development and delivery Provides a defining resource for practitioners in the biopharmaceutical industry, regulators and academics Summarizes the latest knowledge of surfactants in biopharmaceutical development in one comprehensive volume

Fast Dynamic Surfactant Reduces Aggregation of Biologics

Fast Dynamic Surfactant Reduces Aggregation of Biologics Book
Author : Joshua S Katz
Publisher : Unknown
Release : 2017
ISBN : 0987650XXX
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Issues in Pharmacology Pharmacy Drug Research and Drug Innovation 2011 Edition

Issues in Pharmacology  Pharmacy  Drug Research  and Drug Innovation  2011 Edition Book
Author : Anonim
Publisher : ScholarlyEditions
Release : 2012-01-09
ISBN : 1464963428
Language : En, Es, Fr & De

GET BOOK

Book Description :

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 Book
Author : Nicholas W. Warne,Hanns-Christian Mahler
Publisher : Springer
Release : 2018-07-22
ISBN : 3319906038
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book
Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Release : 2010-08-09
ISBN : 0470118121
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Solid State Development and Processing of Pharmaceutical Molecules

Solid State Development and Processing of Pharmaceutical Molecules Book
Author : Michael Gruss
Publisher : John Wiley & Sons
Release : 2021-09-14
ISBN : 3527823069
Language : En, Es, Fr & De

GET BOOK

Book Description :

A guide to the latest industry principles for optimizing the production of solid state active pharmaceutical ingredients Solid State Development and Processing of Pharmaceutical Molecules is an authoritative guide that covers the entire pharmaceutical value chain. The authors—noted experts on the topic—examine the importance of the solid state form of chemical and biological drugs and review the development, production, quality control, formulation, and stability of medicines. The book explores the most recent trends in the digitization and automation of the pharmaceutical production processes that reflect the need for consistent high quality. It also includes information on relevant regulatory and intellectual property considerations. This resource is aimed at professionals in the pharmaceutical industry and offers an in-depth examination of the commercially relevant issues facing developers, producers and distributors of drug substances. This important book: Provides a guide for the effective development of solid drug forms Compares different characterization methods for solid state APIs Offers a resource for understanding efficient production methods for solid state forms of chemical and biological drugs Includes information on automation, process control, and machine learning as an integral part of the development and production workflows Covers in detail the regulatory and quality control aspects of drug development Written for medicinal chemists, pharmaceutical industry professionals, pharma engineers, solid state chemists, chemical engineers, Solid State Development and Processing of Pharmaceutical Molecules reviews information on the solid state of active pharmaceutical ingredients for their efficient development and production.

High Throughput Formulation Development of Biopharmaceuticals

High Throughput Formulation Development of Biopharmaceuticals Book
Author : Vladimir I. Razinkov,Gerd Kleemann
Publisher : Woodhead Publishing
Release : 2016-09-29
ISBN : 190881876X
Language : En, Es, Fr & De

GET BOOK

Book Description :

High Throughput Formulation Development of Biopharmaceuticals: Practical Guide to Methods and Applications provides the latest developments and information on the science of stable and safe drug product formulations, presenting a comprehensive review and detailed description of modern methodologies in the field of formulation development, a process starting with candidate and pre-formulation screening in its early development phase and then progressing to the refinement of robust formulations during commercialization in the later phases of development. The title covers topics such as experiment design, automation of sample preparation and measurements, high-throughput analytics, stress-inducing methods, statistical analysis of large amounts of formulation study data, emerging technologies, and the presentation of several case studies, along with a concluding summary. Presents applications of high-throughput methodologies to accelerate drug formulation development Provides the latest technologies in the field Includes key statistical approaches, such as design of experiment and multivariate data analysis Written by highly respected formulation development experts

Development and Manufacture of Protein Pharmaceuticals

Development and Manufacture of Protein Pharmaceuticals Book
Author : Steve L. Nail,Michael J. Akers
Publisher : Springer Science & Business Media
Release : 2012-12-06
ISBN : 1461505496
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications Book
Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publisher : John Wiley & Sons
Release : 2020-04-13
ISBN : 3527341129
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

New and Future Developments in Microbial Biotechnology and Bioengineering

New and Future Developments in Microbial Biotechnology and Bioengineering Book
Author : Alexandre Gomes Rodrigues
Publisher : Elsevier
Release : 2020-06-10
ISBN : 0444643028
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Surfactant Science and Technology

Surfactant Science and Technology Book
Author : Laurence S. Romsted
Publisher : CRC Press
Release : 2014-05-05
ISBN : 1439882959
Language : En, Es, Fr & De

GET BOOK

Book Description :

Surfactant research explores the forces responsible for surfactant assembly and the critical industrial, medical, and personal applications, including viscosity control, microelectronics, drug stabilization, drug delivery, cosmetics, enhanced oil recovery, and foods. Surfactant Science and Technology: Retrospects and Prospects, "a Festschrift in honor of Dr. Kash Mittal," provides a broad perspective with chapters contributed by leaders in the fields of surfactant-based physical, organic, and materials chemistries. Many of the authors participated in a special symposium in Melbourne, Australia, honoring Kash Mittal’s 100th edited book at the 18th Surfactants in Solution (SIS) meeting. Each chapter provides an overview of a specific research area, with discussions on past, present, and future directions. The book is divided into six parts. Part I reviews the evolution of theoretical models for surfactant self-assembly, and introduces a model for interpreting ion-specific effects on aggregate properties. Part II focuses on interactions of surfactant solutions with solid supports; uses contact angles to understand hydrophobic/hydrophilic changes in a lipid layer; uses surface tension to understand molecular arrangements at interfaces; reviews spreading phenomena; discusses pattern formation on solid surfaces; and applies tensiometry to probe flavor components of espresso. Part III discusses novel DNA-based materials, multifunctional poly(amino acid)s–based graft polymers for drug delivery, and polymeric surfactants for stabilizing suspensions and emulsions. Part IV introduces farm-based biosurfactants from natural products and "greener" biosurfactants from bacteria. Part V explores lyotropic liquid crystals and their applications in triggered drug release; microemulsion properties and controlled drug release; the role of hydrotopes in formulations and in enhancing solubilization in liquid crystals; the potential of ionic liquids to generate tunable and selective reaction media; and provides an overview of stimuli-responsive surfactants. Focusing on emulsions, Part VI reviews the design of emulsion properties for various commercial applications, the role of surfactants in the oil and gas industries, and surfactant mechanisms for soil removal via microemulsions and emulsification.

Handbook of Detergents 6 Volume Set

Handbook of Detergents   6 Volume Set Book
Author : Uri Zoller
Publisher : CRC Press
Release : 2008-11-23
ISBN : 1439832951
Language : En, Es, Fr & De

GET BOOK

Book Description :

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

Poorly Soluble Drugs

Poorly Soluble Drugs Book
Author : Gregory K. Webster,Robert G. Bell,J. Derek Jackson
Publisher : CRC Press
Release : 2017-01-06
ISBN : 1315340860
Language : En, Es, Fr & De

GET BOOK

Book Description :

This book is the first text to provide a comprehensive assessment of the application of fundamental principles of dissolution and drug release testing to poorly soluble compounds and formulations. Such drug products are, vis-à-vis their physical and chemical properties, inherently incompatible with aqueous dissolution. However, dissolution methods are required for product development and selection, as well as for the fulfillment of regulatory obligations with respect to biopharmaceutical assessment and product quality understanding. The percentage of poorly soluble drugs, defined in classes 2 and 4 of the Biopharmaceutics Classification System (BCS), has significantly increased in the modern pharmaceutical development pipeline. This book provides a thorough exposition of general method development strategies for such drugs, including instrumentation and media selection, the use of compendial and non-compendial techniques in product development, and phase-appropriate approaches to dissolution development. Emerging topics in the field of dissolution are also discussed, including biorelevant and biphasic dissolution, the use on enzymes in dissolution testing, dissolution of suspensions, and drug release of non-oral products. Of particular interest to the industrial pharmaceutical professional, a brief overview of the formulation and solubilization techniques employed in the development of BCS class 2 and 4 drugs to overcome solubility challenges is provided and is complemented by a collection of chapters that survey the approaches and considerations in developing dissolution methodologies for enabling drug delivery technologies, including nanosuspensions, lipid-based formulations, and stabilized amorphous drug formulations.

Preclinical Development Handbook

Preclinical Development Handbook Book
Author : Shayne Cox Gad
Publisher : John Wiley & Sons
Release : 2008-03-21
ISBN : 0470249021
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

Excipient Development for Pharmaceutical Biotechnology and Drug Delivery Systems

Excipient Development for Pharmaceutical  Biotechnology  and Drug Delivery Systems Book
Author : Ashok Katdare,Mahesh Chaubal
Publisher : CRC Press
Release : 2006-07-28
ISBN : 9781420004137
Language : En, Es, Fr & De

GET BOOK

Book Description :

To facilitate the development of novel drug delivery systems and biotechnology-oriented drugs, the need for new excipients to be developed and approved continues to increase. Excipient Development for Pharmaceutical, Biotechnology, and Drug Delivery Systems serves as a comprehensive source to improve understanding of excipients and forge new avenues for regulatory review and allowance to use. 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.

Ultrasonic Production of Nano emulsions for Bioactive Delivery in Drug and Food Applications

Ultrasonic Production of Nano emulsions for Bioactive Delivery in Drug and Food Applications Book
Author : Thomas Seak Hou Leong,Sivakumar Manickam,Gregory J. O. Martin,Wu Li,Muthupandian Ashokkumar
Publisher : Springer
Release : 2018-02-21
ISBN : 3319734911
Language : En, Es, Fr & De

GET BOOK

Book Description :

This SpringerBrief provides an overview of ultrasonic emulsification and an update on recent advances in developing stable emulsions for the creation of novel drugs and functional foods, with a focus on bioactive delivery in these products. Emulsification is the process of combining two or more immiscible liquids to form a semi-stable mixture. These two liquids generally consist of an organic (oil) phase and an aqueous (water) phase that is stabilized by the addition of an emulsifier. Most common emulsions are of the oil-in-water (O/W) type, but can also be of water-in-oil (W/O) or even multiple emulsion types (i.e. double emulsions) in the form of water-in-oil-in-water (W/O/W) or oil-in-water-in-oil (O/W/O) phases. The formation of an emulsion requires input of energy to distribute the disperse phase in the continuous phase in small-sized droplets that are able to resist instability. There is great interest in the use of ultrasound to produce emulsions, as it is able to do so relatively efficiently and effectively compared to existing techniques such as rotor stator, high-pressure homogenization and microfluidization. The interaction of ultrasound with the hydrocolloids and biopolymers that are often used to stabilize emulsions can offer advantages such as improved stability or greater control of formed droplet size distributions.

Development of Biopharmaceutical Drug Device Products

Development of Biopharmaceutical Drug Device Products Book
Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publisher : Springer Nature
Release : 2020-03-13
ISBN : 3030314154
Language : En, Es, Fr & De

GET BOOK

Book Description :

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development Book
Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
Publisher : Springer
Release : 2015-04-01
ISBN : 1493923161
Language : En, Es, Fr & De

GET BOOK

Book Description :

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.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Book
Author : John Geigert
Publisher : Springer Science & Business Media
Release : 2014-07-08
ISBN : 1461469163
Language : En, Es, Fr & De

GET BOOK

Book Description :

This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.)

Freeze Drying of Pharmaceutical Products

Freeze Drying of Pharmaceutical Products Book
Author : Davide Fissore,Roberto Pisano,Antonello Barresi
Publisher : CRC Press
Release : 2019-10-24
ISBN : 042966401X
Language : En, Es, Fr & De

GET BOOK

Book Description :

Freeze Drying of Pharmaceutical Products provides an overview of the most recent and cutting-edge developments and technologies in the field, focusing on formulation developments and process monitoring and considering new technologies for process development. This book contains case studies from freeze dryer manufacturers and pharmaceutical companies for readers in industry and academia. It was contributed to by lyophilization experts to create a detailed analysis of the subject matter, organically presenting recent advancements in freeze-drying research and technology. It discusses formulation design, process optimization and control, new PAT-monitoring tools, multivariate image analysis, process scale-down and development using small-scale freeze-dryers, use of CFD for equipment design, and development of continuous processes. This book is for industry professionals, including chemical engineers and pharmaceutical scientists.