Studies on Stable Formulations for a Hydrophobic Cytokine

Studies on Stable Formulations for a Hydrophobic Cytokine PDF Author: Andrea Hawe
Publisher: Cuvillier Verlag
ISBN: 3867270414
Category :
Languages : en
Pages : 199

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Book Description


Studies on Stable Formulations for a Hydrophobic Cytokine

Studies on Stable Formulations for a Hydrophobic Cytokine PDF Author: Andrea Hawe
Publisher: Cuvillier Verlag
ISBN: 3736920415
Category : Science
Languages : en
Pages : 199

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Book Description


Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications PDF Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527341129
Category : Medical
Languages : en
Pages : 394

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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.

Freeze Drying of Pharmaceutical Products

Freeze Drying of Pharmaceutical Products PDF Author: Davide Fissore
Publisher: CRC Press
ISBN: 042966401X
Category : Medical
Languages : en
Pages : 212

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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.

High-Throughput Formulation Development of Biopharmaceuticals

High-Throughput Formulation Development of Biopharmaceuticals PDF Author: Vladimir I. Razinkov
Publisher: Woodhead Publishing
ISBN: 190881876X
Category : Medical
Languages : en
Pages : 133

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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

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals PDF Author: Feroz Jameel
Publisher: John Wiley & Sons
ISBN: 0470118121
Category : Science
Languages : en
Pages : 978

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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.

Analysis of Aggregates and Particles in Protein Pharmaceuticals

Analysis of Aggregates and Particles in Protein Pharmaceuticals PDF Author: Hanns-Christian Mahler
Publisher: John Wiley & Sons
ISBN: 0470497181
Category : Medical
Languages : en
Pages : 480

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Book Description
This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.

Approaches to the Conformational Analysis of Biopharmaceuticals

Approaches to the Conformational Analysis of Biopharmaceuticals PDF Author: Roger L. Lundblad
Publisher: CRC Press
ISBN: 1439807817
Category : Medical
Languages : en
Pages : 370

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Book Description
The activity of many biopharmaceutical polymers is dependent on conformation, and the next several years will see increased interest in the conformational analysis of these polymers resulting from the development of biosimilar or "follow-on" biological products. While a wide variety of approaches to analysis exists, finding the most viable ones wou

Drying Technologies for Biotechnology and Pharmaceutical Applications

Drying Technologies for Biotechnology and Pharmaceutical Applications PDF Author: Satoshi Ohtake
Publisher: John Wiley & Sons
ISBN: 3527802118
Category : Medical
Languages : en
Pages : 366

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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.

Applied Physical Pharmacy, Third Edition

Applied Physical Pharmacy, Third Edition PDF Author: Mansoor Amiji
Publisher: McGraw Hill Professional
ISBN: 1260452220
Category : Medical
Languages : en
Pages : 284

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Book Description
A complete practice-oriented introduction to physical pharmacy Written to clearly and simply explain how drugs work, this textbook explores the fundamental physicochemical attributes and processes important for understanding how a drug is transformed into a usable product that is administered to a patient to reach its pharmacological target, and then exists the body. Applied Physical Pharmacy, Third Edition begins with a review of the key biopharmaceutics concepts of drug liberation, absorption, distribution, metabolism, and excretion. These concepts, and others, set the framework for the subsequent chapters that describe physicochemical properties and process related to the fate of the drug. Other physical pharmacy topics important to drug formulation are discussed in the chapters that follow, which describe dispersal systems, interfacial phenomena, and rheology. The textbook concludes with an overview of the principles of kinetics that are important for understanding the rates at which many of the processes discussed in previous chapters occur. Chapters in this Third Edition retain the acclaimed learning aids of previous editions, including Learning Objectives, Practice Problems, Key Points, and Clinical Questions. In order to be of greater value to the pharmacy student, more clinical questions have been added, and many tables have been updated with more current products and excipients.