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 : /5 from reviews
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Download or read book entitled Therapeutic Protein Drug Products by author: Brian K Meyer which was release on 02 January 2012 and published by Elsevier with total page 200 pages . This book available in PDF, EPUB and Kindle Format. 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 ...

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 ...

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 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 ...

Protein Therapeutics

Protein Therapeutics
  • Author : Zuben E. Sauna,Chava Kimchi-Sarfaty
  • Publisher : Springer
  • Release Date : 2017-07-19
  • Total pages : 182
  • ISBN : 1908818107
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Summary : Medicinal chemistry is both science and art. The science of medicinal chemistry offers mankind one of its best hopes for improving the quality of life. The art of medicinal chemistry continues to challenge its practitioners with the need for both intuition and experience to discover new drugs. Hence sharing the ...

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 ...

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

Pharmaceutical Formulation Development of Peptides and Proteins
  • 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 therap...

Therapeutic Proteins

Therapeutic Proteins
  • Author : Vladimir Voynov,Justin A. Caravella
  • Publisher : Humana Press
  • Release Date : 2016-05-01
  • Total pages : 516
  • ISBN : 1908818107
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Summary : Emphasizing the newest developments in the field, this volume presents detailed methodswith added emphasison therapeutic protein discovery. It features key tips and valuable implementation advice to ensure successful results."...

Biobetters

Biobetters
  • Author : Amy Rosenberg,Barthélemy Demeule
  • Publisher : Springer
  • Release Date : 2015-08-21
  • Total pages : 378
  • ISBN : 1908818107
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Summary : “Biobetters: Protein Engineering to Approach the Curative” discusses the optimization of protein therapeutic products for treatment of human diseases. It is based on the fact that though numerous important therapeutic protein products have been developed for life threatening and chronic diseases that possess acceptable safety and efficacy profiles, these products ...

Pharmaceutical Biotechnology

Pharmaceutical Biotechnology
  • Author : Daan J. A. Crommelin,Robert D. Sindelar,Bernd Meibohm
  • Publisher : Springer Science & Business Media
  • Release Date : 2013-10-22
  • Total pages : 544
  • ISBN : 1908818107
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Summary : This introductory text explains both the basic science and the applications of biotechnology-derived pharmaceuticals, with special emphasis on their clinical use. It serves as a complete one-stop source for undergraduate/graduate pharmacists, pharmaceutical science students, and for those in the pharmaceutical industry. The Fourth Edition will completely update the previous ...

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 ...

Food Drug Cosmetic Law Reporter

Food  Drug  Cosmetic Law Reporter
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 1963
  • Total pages : 212
  • ISBN : 1908818107
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Summary : Read online Food Drug Cosmetic Law Reporter written by , published by which was released on 1963. Download full Food Drug Cosmetic Law Reporter Books now! Available in PDF, ePub and Kindle....

American Biotechnology Laboratory

American Biotechnology Laboratory
  • Author : Anonim
  • Publisher : Unknown
  • Release Date : 2006
  • Total pages : 212
  • ISBN : 1908818107
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Summary : Read online American Biotechnology Laboratory written by , published by which was released on 2006. Download full American Biotechnology Laboratory Books now! Available in PDF, ePub and Kindle....