Biophysical Characterization of Proteins in Developing Biopharmaceuticals - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biophysical Characterization of Proteins in Developing Biopharmaceuticals write by Damian J. Houde. This book was released on 2019-11-13. Biophysical Characterization of Proteins in Developing Biopharmaceuticals available in PDF, EPUB and Kindle. 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
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals write by Feroz Jameel. This book was released on 2010-07-13. Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals available in PDF, EPUB and Kindle. 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.
Biophysical Methods for Biotherapeutics
Biophysical Methods for Biotherapeutics - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biophysical Methods for Biotherapeutics write by Tapan K. Das. This book was released on 2014-02-27. Biophysical Methods for Biotherapeutics available in PDF, EPUB and Kindle. 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 presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.
Physical Methods to Characterize Pharmaceutical Proteins
Physical Methods to Characterize Pharmaceutical Proteins - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Physical Methods to Characterize Pharmaceutical Proteins write by James N. Herron. This book was released on 2013-06-06. Physical Methods to Characterize Pharmaceutical Proteins available in PDF, EPUB and Kindle. Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs.
Biosimilar Drug Product Development
Biosimilar Drug Product Development - read free eBook in online reader or directly download on the web page. Select files or add your book in reader. Download and read online ebook Biosimilar Drug Product Development write by Laszlo Endrenyi. This book was released on 2017-02-24. Biosimilar Drug Product Development available in PDF, EPUB and Kindle. 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.
