Biophysical Characterization of Proteins in Developing Biopharmaceuticals

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 employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

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  • Author : Damian J. Houde
  • Publisher : Elsevier
  • Pages : 586 pages
  • ISBN : 0444641742
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKBiophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
  • Author : Damian J. Houde,Steven A. Berkowitz
  • Publisher : Elsevier
  • Release : 13 November 2019
GET THIS BOOKBiophysical Characterization of Proteins in Developing Biopharmaceuticals

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 employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been

Biosimilar Drug Product Development

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  • Author : Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow
  • Publisher : CRC Press
  • Release : 24 February 2017
GET THIS BOOKBiosimilar Drug Product Development

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

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  • Author : David D. Weis
  • Publisher : John Wiley & Sons
  • Release : 12 January 2016
GET THIS BOOKHydrogen Exchange Mass Spectrometry of Proteins

Hydrogen exchange mass spectrometry is widely recognized for its ability to probe the structure and dynamics of proteins. The application of this technique is becoming widespread due to its versatility for providing structural information about challenging biological macromolecules such as antibodies, flexible proteins and glycoproteins. Although the technique has been around for 25 years, this is the first definitive book devoted entirely to the topic. Hydrogen Exchange Mass Spectrometry of Proteins: Fundamentals, Methods and Applications brings into one comprehensive volume the

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  • Author : Ved Srivastava
  • Publisher : Royal Society of Chemistry
  • Release : 16 August 2019
GET THIS BOOKPeptide Therapeutics

Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis.

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  • Author : Linda O. Narhi
  • Publisher : Springer Science & Business Media
  • Release : 26 February 2013
GET THIS BOOKBiophysics for Therapeutic Protein Development

This book can be used to provide insight into this important application of biophysics for those who are planning a career in protein therapeutic development, and for those outside this area who are interested in understanding it better. The initial chapters describe the underlying theory, and strengths and weaknesses of the different techniques commonly used during therapeutic development. The majority of the chapters discuss the applications of these techniques, including case studies, across the product lifecycle from early discovery, where

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  • Publisher : Springer Nature
  • Release : 13 March 2020
GET THIS BOOKDevelopment of Biopharmaceutical Drug-Device Products

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

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  • Author : Tapan K. Das
  • Publisher : Wiley
  • Release : 28 April 2014
GET THIS BOOKBiophysical Methods for Biotherapeutics

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, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be

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  • Author : Susumu Uchiyama,Fumio Arisaka,Walter F. Stafford,Tom Laue
  • Publisher : Springer
  • Release : 13 May 2016
GET THIS BOOKAnalytical Ultracentrifugation

This book introduces analytical ultracentrifugation (AUC) as a whole, covering essential theoretical and practical aspects as well as its applications in both biological and non-biological systems. Comprehensive characterizations of macromolecules in a solution are now routinely required not only for understanding the solution system but also for producing a solution with better properties. Analytical ultracentrifugation is one of most powerful and reliable techniques for studying the biophysical behavior of solutes in solution. In the last few years, there have been

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  • Author : Daan J. A. Crommelin,Robert D. Sindelar,Bernd Meibohm
  • Publisher : Springer
  • Release : 13 April 2019
GET THIS BOOKPharmaceutical Biotechnology

This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fifth Edition completely updates the previous edition, and also includes additional coverage on the newer approaches such as oligonucleotides, siRNA, gene therapy and nanotech and enzyme replacement therapy.

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  • Author : Nicholas W. Warne,Hanns-Christian Mahler
  • Publisher : Springer
  • Release : 22 July 2018
GET THIS BOOKChallenges in Protein Product Development

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

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  • Author : Feroz Jameel,Susan Hershenson
  • Publisher : John Wiley & Sons
  • Release : 13 July 2010
GET THIS BOOKFormulation and Process Development Strategies for Manufacturing Biopharmaceuticals

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

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  • Author : Jean-Paul Renaud
  • Publisher : John Wiley & Sons
  • Release : 09 January 2020
GET THIS BOOKStructural Biology in Drug Discovery

With the most comprehensive and up-to-date overview of structure-based drug discovery covering both experimental and computational approaches, Structural Biology in Drug Discovery: Methods, Techniques, and Practices describes principles, methods, applications, and emerging paradigms of structural biology as a tool for more efficient drug development. Coverage includes successful examples, academic and industry insights, novel concepts, and advances in a rapidly evolving field. The combined chapters, by authors writing from the frontlines of structural biology and drug discovery, give readers a valuable