High Throughput Formulation Development of Biopharmaceuticals

• Author : Vladimir I. Razinkov,Gerd Kleemann
• Publisher : Woodhead Publishing
• Release Date : 2016-09-29
• Total pages : 132
• ISBN : 190881876X

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Summary : 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 ...

• Author : Feroz Jameel,Susan Hershenson
• Publisher : John Wiley & Sons
• Release Date : 2010-07-13
• Total pages : 976
• ISBN : 190881876X

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Summary : 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 ...

• Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
• Publisher : Springer Nature
• Release Date : 2020-03-13
• Total pages : 893
• ISBN : 190881876X

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Summary : 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 ...

• Author : Damian J. Houde,Steven A. Berkowitz
• Publisher : Elsevier
• Release Date : 2019-11-13
• Total pages : 586
• ISBN : 190881876X

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Summary : Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly ...

• Author : Ajay K. Banga
• Publisher : CRC Press
• Release Date : 2005-09-14
• Total pages : 376
• ISBN : 190881876X

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Summary : Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact ...

• Author : Geoffrey D Tovey
• Publisher : Royal Society of Chemistry
• Release Date : 2018-06-25
• Total pages : 409
• ISBN : 190881876X

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Summary : Formulation is a key step in the drug design process, where the active drug is combined with other substances that maximise the therapeutic potential, safety and stability of the final medicinal product. Modern formulation science deals with biologics as well as small molecules. Regulatory and quality demands, in addition to ...

• Author : Nicholas W. Warne,Hanns-Christian Mahler
• Publisher : Springer
• Release Date : 2018-06-20
• Total pages : 599
• ISBN : 190881876X

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Summary : 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 ...

• Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
• Publisher : Springer
• Release Date : 2015-04-01
• Total pages : 710
• ISBN : 190881876X

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Summary : 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 ...

• Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
• Publisher : John Wiley & Sons
• Release Date : 2020-02-03
• Total pages : 400
• ISBN : 190881876X

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Summary : 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 ...

• Author : Sandeep Nema,John D. Ludwig
• Publisher : CRC Press
• Release Date : 2019-07-19
• Total pages : 1125
• ISBN : 190881876X

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Summary : Parenteral Medications is an authoritative, comprehensive reference work on the formulation and manufacturing of parenteral dosage forms, effectively balancing theoretical considerations with practical aspects of their development. Previously published as a three-volume set, all volumes have been combined into one comprehensive publication that addresses the plethora of changes in the ...

• Author : Ana Catarina Silva,João Nuno Moreira,José Manuel Sousa Lobo,Hugo Almeida
• Publisher : Springer Nature
• Release Date : 2020-02-06
• Total pages : 400
• ISBN : 190881876X

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Summary : This book offers an authoritative review of biopharmaceuticals and their clinical relevance. Biopharmaceuticals have been showing high therapeutic potential by means of biological and biosimilar medicines, particularly for the treatment of cancer, chronic diseases (e.g. diabetes, Crohn's disease, psoriasis and rheumatoid arthritis), neurodegenerative disorders (e.g. multiple sclerosis), and ...

• Author : Lars Hovgaard,Sven Frokjaer,Marco van de Weert
• Publisher : CRC Press
• Release Date : 2012-11-14
• Total pages : 392
• ISBN : 190881876X

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Summary : The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therap...

• Author : Gunter Jagschies,Eva Lindskog,Karol Lacki,Parrish M. Galliher
• Publisher : Elsevier
• Release Date : 2018-01-18
• Total pages : 1308
• ISBN : 190881876X

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Summary : Biopharmaceutical Processing: Development, Design, and Implementation of Manufacturing Processes covers bioprocessing from cell line development to bulk drug substances. The methods and strategies described are essential learning for every scientist, engineer or manager in the biopharmaceutical and vaccines industry. The integrity of the bioprocess ultimately determines the quality of the ...

• Author : Tapan K. Das
• Publisher : Wiley
• Release Date : 2014-04-28
• Total pages : 376
• ISBN : 190881876X

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Summary : With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, ...

• Author : Sarfaraz K. Niazi
• Publisher : CRC Press
• Release Date : 2019-04-26
• Total pages : 544
• ISBN : 190881876X

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Summary : Preformulation studies are the physical, chemical, and biological studies needed to characterize a drug substance for enabling the proper design of a drug product, whereas the effectiveness of a drug product is determined during the formulation studies phase. Though the two disciplines overlap in practice, each is a significantly distinct ...