Therapeutic Protein Drug Products

Written By Brian K Meyer
Therapeutic Protein Drug Products
  • Publsiher : Elsevier
  • Release : 02 January 2012
  • ISBN : 1908818107
  • Pages : 200 pages
  • Rating : 4/5 from 21 reviews
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Read or download book entitled Therapeutic Protein Drug Products written by Brian K Meyer which was release on 02 January 2012, this book published by Elsevier. Available in PDF, EPUB and Kindle Format. Book excerpt: Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, Ph, container type and route of administration. The laboratory formulation sections focus on the most common buffers, excipients, and Ph ranges that are commonly tested in addition to systematic approaches. A brief section on biophysical and analytical analysis is also provided. Properties of therapeutic protein formulations are described and include opalescence, phase separation, color, and subvisible particles. An emphasis is placed on material and process testing to ensure success during manufacturing. The drug product manufacturing process, which includes the process of compounding to filling, is also covered. Methods of delivery in the clinic are addressed, as well as delivery strategies. Finally, a perspective on the regulatory requirements for therapeutic protein formulations is discussed. Provides a list and description of commercially available therapeutic drug products and their formulations A comprehensive and practical overview of protein formulation in the laboratory, manufacturing, and the clinic Discusses recent topics including high protein concentration, phase separation, opalescence, and subvisible particles

Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release Date : 2012-01-02
  • Total pages : 200
  • ISBN : 1908818107
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Summary : Therapeutic protein drug products provides a comprehensive overview of therapeutic protein drug products, with an emphasis on formulation beginning in the laboratory, followed by manufacturing and administration in the clinic. A list of many commercial therapeutic drug products are described and include the product name, dosages, active concentration, buffer, excipients, ...

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development
  • Author : Linda O. Narhi
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-02-26
  • Total pages : 293
  • ISBN : 1908818107
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Summary : 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 ...

Therapeutic Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David C. James
  • Publisher : Humana Press
  • Release Date : 2014-12-02
  • Total pages : 482
  • ISBN : 1908818107
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Summary : With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process ...

Particles in Therapeutic Protein Formulations

Particles in Therapeutic Protein Formulations
  • Author : Pinaki Basu
  • Publisher : Unknown
  • Release Date : 2014
  • Total pages : 108
  • ISBN : 1908818107
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Summary : Therapeutic protein drug products are used in the treatment and mitigation of human diseases for which no or very few alternative therapies are available e.g. Factor VIII, insulin, erythropoietin, interferon alpha, bevacizumab, etanercept etc. Siliconized prefilled syringes are often utilized as a primary container for therapeutic protein drug products. ...

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins
  • Author : Wei Wang,Christopher J. Roberts
  • Publisher : John Wiley & Sons
  • Release Date : 2010-12-28
  • Total pages : 484
  • ISBN : 1908818107
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Summary : 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 ...

Therapeutic Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David C. James
  • Publisher : Humana Press
  • Release Date : 2005-08-15
  • Total pages : 482
  • ISBN : 1908818107
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Summary : With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process ...

Therapeutic Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David Cameron James
  • Publisher : Springer Science & Business Media
  • Release Date : 2005
  • Total pages : 482
  • ISBN : 1908818107
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Summary : This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, formulation and viral inactivation who cover all aspects of protein drug production downstream of the discovery stage. Protocols for the production of therapeutic proteins using a variety of sources are covered. including bacterial and yeast ...

Handbook of Biogeneric Therapeutic Proteins

Handbook of Biogeneric Therapeutic Proteins
  • Author : Sarfaraz K. Niazi
  • Publisher : CRC Press
  • Release Date : 2002-08-15
  • Total pages : 584
  • ISBN : 1908818107
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Summary : More than 20 billion dollars worth of biopharmaceuticals are scheduled to go off-patent by 2006. Given the strong political impetus and the development of technological tools that can answer the questions regulatory authorities may raise, it is inevitable that the FDA and EMEA will allow biogeneric or biosimilar products. Even with all ...

Biological Drug Products

Biological Drug Products
  • Author : Wei Wang,Manmohan Singh
  • Publisher : John Wiley & Sons
  • Release Date : 2013-08-29
  • Total pages : 744
  • ISBN : 1908818107
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Summary : Tested and proven solutions to the challenges of biologicaldrug product development Biological drug products play a central role in combating humandiseases; however, developing new successful biological drugspresents many challenges, including labor intensive productionprocesses, tighter regulatory controls, and increased marketcompetition. This book reviews the current state of the science,offering readers ...

Protein Instability at Interfaces During Drug Product Development

Protein Instability at Interfaces During Drug Product Development
  • Author : Jinjiang Li,Mary E. Krause,Raymond Tu
  • Publisher : Springer Nature
  • Release Date : 2021-02-12
  • Total pages : 338
  • ISBN : 1908818107
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Summary : Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature ...

Continuous Biopharmaceutical Processes

Continuous Biopharmaceutical Processes
  • Author : David Pfister,Lucrèce Nicoud,Massimo Morbidelli
  • Publisher : Cambridge University Press
  • Release Date : 2018-10-31
  • Total pages : 212
  • ISBN : 1908818107
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Summary : This innovative reference provides a coherent and critical view on the potential benefits of a transition from batch to continuous processes in the biopharmaceutical industry, with the main focus on chromatography. It also covers the key topics of protein stability and protein conjugation, addressing the chemical reaction and purification aspects ...

Challenges in Protein Product Development

Challenges in Protein Product Development
  • Author : Nicholas W. Warne,Hanns-Christian Mahler
  • Publisher : Springer
  • Release Date : 2018-07-22
  • Total pages : 599
  • ISBN : 1908818107
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Summary : 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 ...

Analytical Ultracentrifugation

Analytical Ultracentrifugation
  • Author : Susumu Uchiyama,Fumio Arisaka,Walter F. Stafford,Tom Laue
  • Publisher : Springer
  • Release Date : 2016-05-13
  • Total pages : 532
  • ISBN : 1908818107
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Summary : This book introduces analytical ultracentrifugation (AUC) as a whole, covering essential theoretical and practical aspects as well as its applications in both biological and non-biological systems. Comprehensive characterizations of macromolecules in a solution are now routinely required not only for understanding the solution system but also for producing a solution ...

Pharmaceutical Formulation Development of Peptides and Proteins Second Edition

Pharmaceutical Formulation Development of Peptides and Proteins  Second Edition
  • Author : Lars Hovgaard,Sven Frokjaer,Marco van de Weert
  • Publisher : CRC Press
  • Release Date : 2012-11-14
  • Total pages : 392
  • ISBN : 1908818107
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Summary : The rapid advances in recombinant DNA technology and the increasing availability of peptides and proteins with therapeutic potential are a challenge for pharmaceutical scientists who have to formulate these compounds as drug products. Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition discusses the development of therapeutic peptides and proteins, ...

Therapeutic Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David C. James
  • Publisher : Humana
  • Release Date : 2005-08-15
  • Total pages : 482
  • ISBN : 1908818107
GET BOOK

Summary : With the recent completion of the sequencing of the human genome, it is widely anticipated that the number of potential new protein drugs and targets will escalate at an even greater rate than that observed in recent years. However, identification of a potential target is only part of the process ...