Therapeutic Protein Drug Products

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Read or download book entitled Therapeutic Protein Drug Products written by Brian K Meyer and published by Elsevier in PDF, EPUB and Kindle Format. Click Get This Book button to download or read online books. Join over 650.000 happy Readers and READ as many books as you like. We cannot guarantee that Therapeutic Protein Drug Products book is available in the library.

  • Publisher : Elsevier
  • Release : 02 January 2012
  • ISBN : 9781908818102
  • Page : 200 pages
  • Rating : 4.5/5 from 103 voters

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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

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Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release Date : 2012-01-02
  • ISBN : 9781908818102
GET THIS BOOKTherapeutic Protein Drug Products

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.

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins
  • Author : Wei Wang,Christopher J. Roberts
  • Publisher : John Wiley & Sons
  • Release Date : 2010-12-28
  • ISBN : 1118043588
GET THIS BOOKAggregation of Therapeutic Proteins

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

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
  • ISBN : 9781439853887
GET THIS BOOKPharmaceutical Formulation Development of Peptides and Proteins, Second Edition

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, from the production of active compounds via basic pre-formulation and formulation to the registration of the final product. Providing integrated solutions, this book discusses: The synthesis of peptides and the

Therapeutic Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David C. James
  • Publisher : Humana Press
  • Release Date : 2014-12-02
  • ISBN : 1627038485
GET THIS BOOKTherapeutic Proteins

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 in developing these new next generation protein-based “drugs” that are increasingly being used to treat human disease. Once a potential protein drug has been identified, the next rate-limiting step on

Therapeutic Proteins

Therapeutic Proteins
  • Author : Vladimir Voynov,Justin A. Caravella
  • Publisher : Humana Press
  • Release Date : 2016-05-01
  • ISBN : 1493959492
GET THIS BOOKTherapeutic Proteins

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."

Monoclonal Antibodies

Monoclonal Antibodies
  • Author : Steven Shire
  • Publisher : Woodhead Publishing
  • Release Date : 2015-04-24
  • ISBN : 9780081002971
GET THIS BOOKMonoclonal Antibodies

Monoclonal antibodies (MAbs) are currently the major class of protein bio therapeutic being developed by biotechnology and pharmaceutical companies. Monoclonal Antibodies discusses the challenges and issues revolving around development of a monoclonal antibody produced by recombinant DNA technology into a therapeutic agent.This book covers downstream processing which includes design of processes to manufacture the formulation, formulation design, fill and finish into closure systems and routes of administration. The characterization of the final drug product is covered where the use

Protein Therapeutics, 2 Volume Set

Protein Therapeutics, 2 Volume Set
  • Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
  • Publisher : John Wiley & Sons
  • Release Date : 2017-12-04
  • ISBN : 9783527340866
GET THIS BOOKProtein Therapeutics, 2 Volume Set

In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins

ADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins
  • Author : Honghui Zhou,Frank-Peter Theil
  • Publisher : John Wiley & Sons
  • Release Date : 2015-10-26
  • ISBN : 9781118898802
GET THIS BOOKADME and Translational Pharmacokinetics / Pharmacodynamics of Therapeutic Proteins

With an emphasis on the fundamental and practical aspects of ADME for therapeutic proteins, this book helps readers strategize, plan and implement translational research for biologic drugs. • Details cutting-edge ADME (absorption, distribution, metabolism and excretion) and PKPD (pharmacokinetic / pharmacodynamics) modeling for biologic drugs • Combines theoretical with practical aspects of ADME in biologic drug discovery and development and compares innovator biologics with biosimilar biologics and small molecules with biologics, giving a lessons-learned perspective • Includes case studies about leveraging ADME to improve

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development
  • Author : Linda O. Narhi
  • Publisher : Springer Science & Business Media
  • Release Date : 2012-10-03
  • ISBN : 1489992464
GET THIS BOOKBiophysics for Therapeutic Protein Development

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

Challenges in Protein Product Development

Challenges in Protein Product Development
  • Author : Nicholas W. Warne,Hanns-Christian Mahler
  • Publisher : Springer
  • Release Date : 2018-06-20
  • ISBN : 9783319906034
GET THIS BOOKChallenges in Protein Product Development

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

Protein Therapeutics

Protein Therapeutics
  • Author : Zuben E. Sauna,Chava Kimchi-Sarfaty
  • Publisher : Springer
  • Release Date : 2017-07-19
  • ISBN : 9783319418186
GET THIS BOOKProtein Therapeutics

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 experience of drug research is uniquely beneficial to the field of medicinal chemistry. Drug research requires interdisciplinary team-work at the interface between chemistry, biology and medicine. Therefore, the topic-related series

Therapeutic Antibody Engineering

Therapeutic Antibody Engineering
  • Author : William R Strohl,Lila M Strohl
  • Publisher : Elsevier
  • Release Date : 2012-10-16
  • ISBN : 9781908818096
GET THIS BOOKTherapeutic Antibody Engineering

The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental

Peptide and Protein Delivery

Peptide and Protein Delivery
  • Author : Chris Van Der Walle
  • Publisher : Academic Press
  • Release Date : 2011-05-12
  • ISBN : 0123849365
GET THIS BOOKPeptide and Protein Delivery

The growing area of peptide and protein therapeutics research is of paramount importance to medical application and advancement. A needed reference for entry level researchers and researchers working in interdisciplinary / collaborative projects, Peptide and Protein Delivery addresses the current and emerging routes for delivery of therapeutics. Covering cerebral delivery, pulmonary delivery, transdermal delivery, intestinal delivery, ocular delivery, parenteral delivery, and nasal delivery, this resource offers an overview of the main routes in therapeutics. Researchers across biochemistry, pharmaceutical, molecular biology, cell

Protein Therapeutics

Protein Therapeutics
  • Author : Tristan Vaughan,Jane Osbourn,Bahija Jallal
  • Publisher : John Wiley & Sons
  • Release Date : 2017-07-28
  • ISBN : 9783527699131
GET THIS BOOKProtein Therapeutics

In this practice-oriented two volume handbook, professionals from some of the largest biopharmaceutical companies and top academic researchers address the key concepts and challenges in the development of protein pharmaceuticals for medicinal chemists and drug developers of all trades. Following an introduction tracing the rapid development of the protein therapeutics market over the last decade, all currently used therapeutic protein scaffolds are surveyed, from human and non-human antibodies to antibody mimetics, bispecific antibodies and antibody-drug conjugates. This ready reference then

Pharmaceutical Biotechnology

Pharmaceutical Biotechnology
  • Author : Gary Walsh
  • Publisher : John Wiley & Sons
  • Release Date : 2013-04-25
  • ISBN : 9781118685754
GET THIS BOOKPharmaceutical Biotechnology

Pharmaceutical Biotechnology offers students taking Pharmacy and related Medical and Pharmaceutical courses a comprehensive introduction to the fast-moving area of biopharmaceuticals. With a particular focus on the subject taken from a pharmaceutical perspective, initial chapters offer a broad introduction to protein science and recombinant DNA technology- key areas that underpin the whole subject. Subsequent chapters focus upon the development, production and analysis of these substances. Finally the book moves on to explore the science, biotechnology and medical applications of specific