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, ...

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 ...

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 ...

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 C. James
  • Publisher : Humana
  • 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 ...

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 ...

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, ...

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 ...

Therapeutic Protein and Peptide Formulation and Delivery

Therapeutic Protein and Peptide Formulation and Delivery
  • Author : Zahra Shahrokh,American Chemical Society. Division of Biochemical Technology
  • Publisher : Amer Chemical Society
  • Release Date : 1997
  • Total pages : 228
  • ISBN : 1908818107
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Summary : This volume reviews protein stability and the analytical and biophysical characterization of proteins. It emphasizes drug delivery approaches, especially local delivery through the skin. Including both academic and industrial perspectives from such companies as Genentech, Amgen, and Merck, the book also discusses novel drug delivery polymers and the development of ...

American Journal of Hospital Pharmacy

American Journal of Hospital Pharmacy
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1989-07
  • Total pages : 212
  • ISBN : 1908818107
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Summary : Download or read online American Journal of Hospital Pharmacy written by , published by which was released on 1989-07. Get American Journal of Hospital Pharmacy Books now! Available in PDF, ePub and Kindle....

ASM News

ASM News
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1991
  • Total pages : 212
  • ISBN : 1908818107
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Summary : Download or read online ASM News written by , published by which was released on 1991. Get ASM News Books now! Available in PDF, ePub and Kindle....

Subvisible Particles in Therapeutic Protein Products and Potential Biological Consequences

Subvisible Particles in Therapeutic Protein Products and Potential Biological Consequences
  • Author : Neha Pardeshi
  • Publisher : Unknown
  • Release Date : 2016
  • Total pages : 117
  • ISBN : 1908818107
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Summary : Therapeutic proteins offer treatment options for a variety of chronic medical conditions including cancer, diabetes, rheumatoid arthritis etc. However, all therapeutic proteins have an inherent potential to cause immune responses. Moreover, product quality attributes like protein aggregates even in low concentration are implicated in eliciting an immune response. Specifically proteinaceous ...

Inhalation Delivery of Therapeutic Peptides and Proteins

Inhalation Delivery of Therapeutic Peptides and Proteins
  • Author : Akwete Adjei
  • Publisher : CRC Press
  • Release Date : 1997-07-08
  • Total pages : 952
  • ISBN : 1908818107
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Summary : This exhaustive reference-the first book of its kind to describe in detail the functionality of the human respiratory tract and its impact on both local and systemic delivery of biotherapeutic and macromolecular drug systems-offers comprehensive analyses of peptide and protein drug delivery through the lung. Summarizes over 130 patents granted worldwide ...