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

Produk Detail:

  • 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

Biosimilar Drug Product Development
  • 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.

Challenges in Protein Product Development

Challenges in Protein Product Development
  • Author : Nicholas W. Warne,Hanns-Christian Mahler
  • Publisher : Springer
  • Release : 20 June 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

Hydrogen Exchange Mass Spectrometry of Proteins

Hydrogen Exchange Mass Spectrometry of Proteins
  • 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

Mass Spectrometry in Biopharmaceutical Analysis

Mass Spectrometry in Biopharmaceutical Analysis
  • Author : Igor A. Kaltashov,Guanbo Wang,Shunhai Wang
  • Publisher : Walter de Gruyter GmbH & Co KG
  • Release : 22 November 2021
GET THIS BOOKMass Spectrometry in Biopharmaceutical Analysis

Biopharmaceuticals are a unique class of compounds due to their extreme structural complexity. The current text puts together a variety of the state‐of‐the art approaches that use mass spectrometry to evaluate various aspects of biopharmaceutical products ranging from monitoring stress‐related structural changes to their quantitation in pharmacokinetic studies.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • 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

Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
  • 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

Development of Biopharmaceutical Drug-Device Products

Development of Biopharmaceutical Drug-Device Products
  • Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
  • 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

Therapeutic Proteins

Therapeutic Proteins
  • Author : Vladimir Voynov,Justin A. Caravella
  • Publisher : Humana Press
  • Release : 01 May 2016
GET THIS BOOKTherapeutic Proteins

Emphasizing the newest developments in the field, this volume presents detailed methodswith added emphasison therapeutic protein discovery. It features key tips and valuable implementation advice to ensure successful results."

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins
  • Author : Wei Wang,Christopher J. Roberts
  • Publisher : John Wiley & Sons
  • Release : 28 December 2010
GET THIS BOOKAggregation of Therapeutic Proteins

This book gives pharmaceutical scientists an up-to-date resource on protein aggregation and its consequences, and available methods to control or slow down the aggregation process. While significant progress has been made in the past decade, the current understanding of protein aggregation and its consequences is still immature. Prevention or even moderate inhibition of protein aggregation has been mostly experimental. The knowledge in this book can greatly help pharmaceutical scientists in the development of therapeutic proteins, and also instigate further scientific

Nanopharmaceuticals: Principles and Applications Vol. 3

Nanopharmaceuticals: Principles and Applications Vol. 3
  • Author : Vinod Kumar Yata,Shivendu Ranjan,Nandita Dasgupta,Eric Lichtfouse
  • Publisher : Springer Nature
  • Release : 19 August 2020
GET THIS BOOKNanopharmaceuticals: Principles and Applications Vol. 3

This book is the third volume on this subject and focuses on the recent advances of nanopharmaceuticals in cancer, dental, dermal and drug delivery applications and presents their safety, toxicity and therapeutic efficacy. The book also includes the transport phenomenon of nanomaterials and important pathways for drug delivery applications. It goes on to explain the toxicity of nanoparticles to different physiological systems and methods used to assess this for different organ systems using examples of in vivo systems.

Analytical Ultracentrifugation

Analytical Ultracentrifugation
  • Author : James L. Cole
  • Publisher : Academic Press
  • Release : 01 October 2015
GET THIS BOOKAnalytical Ultracentrifugation

Analytical Ultracentrifugation, the latest volume in Methods in Enzymology, focuses on analytical ultracentrifugation. The scope of this technique has greatly expanded in recent years due to advances in instrumentation, algorithms and software. This volume describes the latest innovations in the field and in the applications of analytical ultracentrifugation in the analysis of macromolecules, macromolecular assemblies, and biopharmaceuticals. Timely contribution that describes a rapidly changing field Leading researchers in the field Broad coverage: instrumentation, basic theory, data analysis, and applications

Drug Metabolism, Pharmacokinetics and Bioanalysis

Drug Metabolism, Pharmacokinetics and Bioanalysis
  • Author : Hye Suk Lee,Kwang-Hyeon Liu
  • Publisher : MDPI
  • Release : 12 June 2019
GET THIS BOOKDrug Metabolism, Pharmacokinetics and Bioanalysis

Drug metabolism/pharmacokinetics and drug interaction studies have been extensively carried out in order to secure the druggability and safety of new chemical entities throughout the development of new drugs. Recently, drug metabolism and transport by phase II drug metabolizing enzymes and drug transporters, respectively, as well as phase I drug metabolizing enzymes, have been studied. A combination of biochemical advances in the function and regulation of drug metabolizing enzymes and automated analytical technologies are revolutionizing drug metabolism research. There

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
  • Author : John Geigert
  • Publisher : Springer Science & Business Media
  • Release : 06 December 2012
GET THIS BOOKThe Challenge of CMC Regulatory Compliance for Biopharmaceuticals

"The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would

Advances in Chitin/Chitosan Characterization and Applications

Advances in Chitin/Chitosan Characterization and Applications
  • Author : Marguerite Rinaudo,Francisco M. Goycoolea
  • Publisher : MDPI
  • Release : 23 April 2019
GET THIS BOOKAdvances in Chitin/Chitosan Characterization and Applications

Functional advanced biopolymers have received far less attention than renewable biomass (cellulose, rubber, etc.) used for energy production. Among the most advanced biopolymers known is chitosan. The term chitosan refers to a family of polysaccharides obtained by partial de-N-acetylation from chitin, one of the most abundant renewable resources in the biosphere. Chitosan has been firmly established as having unique material properties as well as biological activities. Either in its native form or as a chemical derivative, chitosan is amenable to