• Home
  • Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
  • Author : Damian J. Houde
  • Publsiher : Elsevier
  • Release : 13 November 2019
  • ISBN : 0444641742
  • Pages : 586 pages
  • Rating : 4/5 from 21 ratings
GET THIS BOOKBiophysical Characterization of Proteins in Developing Biopharmaceuticals

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 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


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

Book Biophysical Characterization of Proteins in Developing Biopharmaceuticals PDF Download/ Read Online


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.

Book Biosimilar Drug Product Development PDF Download/ Read Online


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

Book Challenges in Protein Product Development PDF Download/ Read Online


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

Book Hydrogen Exchange Mass Spectrometry of Proteins PDF Download/ Read Online


Analytical Characterization of Biotherapeutics

Analytical Characterization of Biotherapeutics
  • Author : Jennie R. Lill,Wendy Sandoval
  • Publisher : John Wiley & Sons
  • Release : 14 August 2017
GET THIS BOOKAnalytical Characterization of Biotherapeutics

The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting

Book Analytical Characterization of Biotherapeutics PDF Download/ Read Online


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.

Book Mass Spectrometry in Biopharmaceutical Analysis PDF Download/ Read Online


Frontiers in Clinical Drug Research - Dementia: Volume 1

Frontiers in Clinical Drug Research - Dementia: Volume 1
  • Author : Atta-ur-Rahman
  • Publisher : Bentham Science Publishers
  • Release : 02 June 2020
GET THIS BOOKFrontiers in Clinical Drug Research - Dementia: Volume 1

Frontiers in Clinical Drug Research - Dementia is a book series which presents comprehensive reviews about research on Dementia, - the loss of brain function associated with Alzheimer’s disease and other related medical conditions. The disease affects the parts of the brain that deal with memory, thought, and language. Chapters in each volume focus on drug research with special emphasis on clinical trials, research on drugs in advanced stages of development and cure for dementia and related disorders. This

Book Frontiers in Clinical Drug Research - Dementia: Volume 1 PDF Download/ Read Online


Vaccinology and Methods in Vaccine Research

Vaccinology and Methods in Vaccine Research
  • Author : Rebecca Ashfield,Angus Nnamdi Oli,Charles Esimone,Linda Onyeka Anagu
  • Publisher : Academic Press
  • Release : 23 March 2022
GET THIS BOOKVaccinology and Methods in Vaccine Research

Vaccinology and Methods in Vaccine Research is a combination of cutting-edge methodologies, experimental approaches and literature reviews. The book covers all aspects of vaccine development, including basic immunology (focusing on the stimulation of adaptive immunity, which is required for vaccine efficacy), approaches to vaccine design and target validation, vaccine biomanufacturer and clinical development. Existing vaccinology resources are theoretical reference books, whereas this book provides a practical handbook for use in the research lab and classroom by those working in vaccinology

Book Vaccinology and Methods in Vaccine Research PDF Download/ Read Online


Analytical Techniques in the Pharmaceutical Sciences

Analytical Techniques in the Pharmaceutical Sciences
  • Author : Anette Müllertz,Yvonne Perrie,Thomas Rades
  • Publisher : Springer
  • Release : 30 August 2016
GET THIS BOOKAnalytical Techniques in the Pharmaceutical Sciences

The aim of this book is to present a range of analytical methods that can be used in formulation design and development and focus on how these systems can be applied to understand formulation components and the dosage form these build. To effectively design and exploit drug delivery systems, the underlying characteristic of a dosage form must be understood--from the characteristics of the individual formulation components, to how they act and interact within the formulation, and finally, to how this

Book Analytical Techniques in the Pharmaceutical Sciences PDF Download/ Read Online


Handbook of Analytical Quality by Design

Handbook of Analytical Quality by Design
  • Author : Sarwar Beg,Md Saquib Hasnain,Mahfoozur Rahman,Waleed H. Almalki
  • Publisher : Academic Press
  • Release : 09 January 2021
GET THIS BOOKHandbook of Analytical Quality by Design

Handbook of Analytical Quality by Design addresses the steps involved in analytical method development and validation in an effort to avoid quality crises in later stages. The AQbD approach significantly enhances method performance and robustness which are crucial during inter-laboratory studies and also affect the analytical lifecycle of the developed method. Sections cover sample preparation problems and the usefulness of the QbD concept involving Quality Risk Management (QRM), Design of Experiments (DoE) and Multivariate (MVT) Statistical Approaches to solve by

Book Handbook of Analytical Quality by Design PDF Download/ Read Online


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

Book Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals PDF Download/ Read Online


Biophysical Methods for Biotherapeutics

Biophysical Methods for Biotherapeutics
  • Author : Tapan K. Das
  • Publisher : John Wiley & Sons
  • Release : 27 February 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

Book Biophysical Methods for Biotherapeutics PDF Download/ Read Online


Quality by Design for Biopharmaceutical Drug Product Development

Quality by Design for Biopharmaceutical Drug Product Development
  • Author : Feroz Jameel,Susan Hershenson,Mansoor A. Khan,Sheryl Martin-Moe
  • Publisher : Springer
  • Release : 01 April 2015
GET THIS BOOKQuality by Design for Biopharmaceutical Drug Product Development

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

Book Quality by Design for Biopharmaceutical Drug Product Development PDF Download/ Read Online


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

Book Development of Biopharmaceutical Drug-Device Products PDF Download/ Read Online


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

Book Biophysical Methods for Biotherapeutics PDF Download/ Read Online