Analysis of Aggregates and Particles in Protein Pharmaceuticals

Author: Hanns-Christian Mahler
Publisher: John Wiley & Sons
ISBN: 1118150562
Format: PDF
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This book describes how to address the analysis of aggregates and particles in protein pharmaceuticals, provides a comprehensive overview of current methods and integrated approaches used to quantify and characterize aggregates and particles, and discusses regulatory requirements. Analytical methods covered in the book include separation, light scattering, microscopy, and spectroscopy.

Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Author: Damian J. Houde
Publisher: Newnes
ISBN: 0444595902
Format: PDF, ePub
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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.

Challenges in Protein Product Development

Author: Nicholas W. Warne
Publisher: Springer
ISBN: 3319906038
Format: PDF, Mobi
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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 or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

Methods for Structural Analysis of Protein Pharmaceuticals

Author: Wim Jiskoot
Publisher: Springer Science & Business Media
ISBN: 9780971176720
Format: PDF
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Protein pharmaceuticals form a fast-growing category in the arsenal of drugs. This book explores the nature of different analytical techniques and the way in which they are related to pharmaceutical proteins. In addition to serving the analytical chemist, this book is needed by the formulation scientist who is responsible for design and formulation of a pharmaceutical protein that can be monitored during production and over time.

Biophysics for Therapeutic Protein Development

Author: Linda O. Narhi
Publisher: Springer Science & Business Media
ISBN: 1461443164
Format: PDF, ePub
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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.

Advances in Hydrogen Sulfide Research and Application 2011 Edition

Author:
Publisher: ScholarlyEditions
ISBN: 1464927669
Format: PDF, ePub, Mobi
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Advances in Hydrogen Sulfide Research and Application: 2011 Edition is a ScholarlyBrief™ that delivers timely, authoritative, comprehensive, and specialized information about Hydrogen Sulfide in a concise format. The editors have built Advances in Hydrogen Sulfide Research and Application: 2011 Edition on the vast information databases of ScholarlyNews.™ You can expect the information about Hydrogen Sulfide in this eBook to be deeper than what you can access anywhere else, as well as consistently reliable, authoritative, informed, and relevant. The content of Advances in Hydrogen Sulfide Research and Application: 2011 Edition has been produced by the world’s leading scientists, engineers, analysts, research institutions, and companies. All of the content is from peer-reviewed sources, and all of it is written, assembled, and edited by the editors at ScholarlyEditions™ and available exclusively from us. You now have a source you can cite with authority, confidence, and credibility. More information is available at http://www.ScholarlyEditions.com/.

Aggregation of Therapeutic Proteins

Author: Wei Wang
Publisher: John Wiley & Sons
ISBN: 9781118043585
Format: PDF
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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 investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.

Continuous Processing in Pharmaceutical Manufacturing

Author: Ganapathy Subramanian
Publisher: John Wiley & Sons
ISBN: 3527673709
Format: PDF, ePub, Mobi
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With contributions from biotechnologists and bioengineers, this ready reference describes the state of the art in industrial biopharmaceutical production, with a strong focus on continuous processes. Recent advances in single-use technology as well as application guidelines for all types of biopharmaceutical products, from vaccines to antibodies, and from bacterial to insect to mammalian cells are covered. The efficiency, robustness, and quality control of continuous production processes for biopharmaceuticals are reviewed and compared to traditional batch processes for a range of different production systems.

Novel Therapeutics from Modern Biotechnology

Author: Dale L. Oxender
Publisher: Springer
ISBN:
Format: PDF, Docs
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While addressing the particular problems associated with several classes of biotechnology products, this book also demonstrates that the principles are the same as in the development of small new chemical entities. It begins by studying FDA regulatory expectations for biotech products, before moving on to discuss general issues common to each class of biotech drug, such as proteins, peptides, and nucleic acids. The text deals with specific biotech drugs that have successfully made it into clinical trials, and each review is written by a renowned expert in the relevant fields.