Biophysical Characterization of Proteins in Developing Biopharmaceuticals
Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author: Damian J. Houde

Publisher: Newnes

Published: 2014-09-05

Total Pages: 427

ISBN-13: 0444595902

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals is concerned with 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 takes the reader on a journey on how to best achieve this goal using the key relevant and practical methods commonly employed in the biopharmaceutical industry today as well as up and coming promising methods that are now gaining increasing attention. As a general resource guide this book has been written with the intent to help today’s industrial scientists working in the biopharmaceutical industry or the scientists of tomorrow who are planning a career in this industry on how to successfully implement these biophysical methodologies. In so doing a keen focus is placed on understanding the capability of these methodologies in terms of what information they can deliver. Aspects of how to best acquire this biophysical information on these very complex drug molecules, while avoiding potential pitfalls, in order to make concise, well informed productive decisions about their development are key points that are also covered. Presents the reader with a clear understanding of the real world issues and challenges in using these methods. Highlights the capabilities and limitations of each method. Discusses how to best analyze the data generated from these methods. Points out what one needs to look for to avoid making faulty conclusions and mistakes. In total it provides a check list or road map that empowers the industrial scientists as to what they need to be concerned with in order to effectively do their part in successfully developing these new drugs in an efficient and cost effective manner.

Biophysics for Therapeutic Protein Development
Biophysics for Therapeutic Protein Development

Author: Linda O. Narhi

Publisher: Springer Science & Business Media

Published: 2013-02-26

Total Pages: 299

ISBN-13: 1461443164

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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 the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.

Physical Methods to Characterize Pharmaceutical Proteins
Physical Methods to Characterize Pharmaceutical Proteins

Author: James N. Herron

Publisher: Boom Koninklijke Uitgevers

Published: 1995-09-30

Total Pages: 398

ISBN-13: 9780306450266

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This collection of state-of-the-art research describes the most frequently used techniques for structural analysis of proteins. Chapters focus on the impressive progress that has been made in the development of these techniques and identify future trends and research needs. Papers feature several spectroscopic techniques-including fluorescence spectroscopy, circular dichroism, and infrared spectroscopy.

Biophysical Methods for Biotherapeutics
Biophysical Methods for Biotherapeutics

Author: Tapan K. Das

Publisher: John Wiley & Sons

Published: 2014-04-28

Total Pages: 380

ISBN-13: 0470938439

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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.

Purification and Characterization of Therapeutic Protein
Purification and Characterization of Therapeutic Protein

Author: L. Premraj

Publisher: Independent Author

Published: 2023-04-10

Total Pages: 0

ISBN-13: 9781805281573

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The research paper titled "Purification and Characterization of Therapeutic Protein" authored by L. Premraj explores the purification and structural characterization of a therapeutic protein obtained from the haemolymph of the marine crab Grapsus albolineatus Milbert 1812. The paper highlights the importance of protein purification and structural characterization in the development of biotherapeutics and biopharmaceuticals. Protein purification is a critical step in the development of biotherapeutics and biopharmaceuticals. In this study, the authors have utilized various techniques such as chromatography, electrophoresis, and mass spectrometry for the purification and structural characterization of the therapeutic protein obtained from the haemolymph of the marine crab Grapsus albolineatus. The purified protein was characterized using various techniques, including amino acid sequencing, post-translational modification analysis, and biophysical and biochemical analyses. The molecular weight, glycosylation, protein folding, and conformational analysis of the protein were also studied. The results of the characterization showed that the protein has high biological activity and binding affinity, making it suitable for drug development. The study also highlights the importance of formulation development, quality control, batch-to-batch consistency, and stability analysis in the development of biotherapeutics and biopharmaceuticals. The therapeutic efficacy, pharmacokinetics, pharmacodynamics, immunogenicity, and toxicity evaluation of the protein were also studied in preclinical and clinical trials. Moreover, the research emphasizes the importance of regulatory compliance and good manufacturing practices in the bioprocessing and downstream processing of the protein. The study also explores the use of protein engineering and recombinant protein technology for the development of biotherapeutics and biopharmaceuticals. In conclusion, this research paper provides valuable insights into the purification and characterization of a therapeutic protein obtained from the haemolymph of the marine crab Grapsus albolineatus. The study highlights the importance of protein purification and structural characterization in the development of biotherapeutics and biopharmaceuticals. The findings of this study will contribute to the development of novel and effective drugs for the benefit of society

Biophysical Characterization of Proteins in Developing Biopharmaceuticals
Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author: Damian J. Houde

Publisher: Elsevier

Published: 2019-11-13

Total Pages: 586

ISBN-13: 0444641742

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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

Author: Feroz Jameel

Publisher: John Wiley & Sons

Published: 2010-07-13

Total Pages: 986

ISBN-13: 0470595876

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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.

Biosimilar Drug Product Development
Biosimilar Drug Product Development

Author: Laszlo Endrenyi

Publisher: CRC Press

Published: 2017-02-24

Total Pages: 379

ISBN-13: 1351646184

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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.