Therapeutic 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. 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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  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Pages : 200 pages
  • ISBN : 1908818107
  • Rating : 4/5 from 21 reviews
CLICK HERE TO GET THIS BOOKTherapeutic Protein Drug Products

Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
  • Author : Brian K Meyer
  • Publisher : Elsevier
  • Release : 02 January 2012
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.

Particles in Therapeutic Protein Formulations

Particles in Therapeutic Protein Formulations
  • Author : Pinaki Basu
  • Publisher : Unknown Publisher
  • Release : 19 October 2021
GET THIS BOOKParticles in Therapeutic Protein Formulations

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. Despite efforts to maintain high product quality, the formation of unwanted particles is occasionally observed in therapeutic protein formulations in siliconized prefilled syringes. During the last few years, interest in

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development
  • Author : Linda O. Narhi
  • Publisher : Springer Science & Business Media
  • Release : 26 February 2013
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

Therapeutic Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David C. James
  • Publisher : Humana Press
  • Release : 02 December 2014
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 : 01 May 2016
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."

Therapeutic Proteins

Therapeutic Proteins
  • Author : Roland Kontermann
  • Publisher : John Wiley & Sons
  • Release : 31 January 2012
GET THIS BOOKTherapeutic Proteins

For this ready reference, the internationally renowned authority in the field, Roland Kontermann, has assembled a team of outstanding contributors from industry and academia to convey the worldwide knowledge on modifying therapeutic proteins in order to optimize their pharmacological potential. The result is a comprehensive work covering all approaches and aspects of the topic in one handy volume, making this indispensable reading for companies and research institutions working on the development of biopharmaceuticals.

Protein Therapeutics

Protein Therapeutics
  • Author : Zuben E. Sauna,Chava Kimchi-Sarfaty
  • Publisher : Springer
  • Release : 19 July 2017
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 Proteins

Therapeutic Proteins
  • Author : C. Mark Smales,David C. James
  • Publisher : Humana Press
  • Release : 15 August 2005
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

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins
  • Author : Wei Wang,Christopher J. Roberts
  • Publisher : John Wiley & Sons
  • Release : 28 December 2010
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

Peptide Therapeutics

Peptide Therapeutics
  • Author : Ved Srivastava
  • Publisher : Royal Society of Chemistry
  • Release : 28 August 2019
GET THIS BOOKPeptide Therapeutics

Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis.

Peptide and Protein Delivery

Peptide and Protein Delivery
  • Author : Chris Van Der Walle
  • Publisher : Academic Press
  • Release : 12 May 2011
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

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines
  • Author : Dushyant Varshney,Manmohan Singh
  • Publisher : Springer
  • Release : 19 May 2015
GET THIS BOOKLyophilized Biologics and Vaccines

This book provides a detailed account of the most recent developments, challenges and solutions to seamlessly advance and launch a lyophilized biologics or vaccine product, based on diverse modalities, ranging from antibodies (e.g., monoclonal, fused), complex biologics (e.g., antibody drug conjugate, PEGylated proteins), and vaccines (e.g., recombinant-protein based). The authors adeptly guide the reader through all crucial aspects, from biophysical and chemical stability considerations of proteins, analytical methods, advances in controlled ice nucleation and quality-by-design approaches, alternate

Biological Drug Products

Biological Drug Products
  • Author : Wei Wang,Manmohan Singh
  • Publisher : John Wiley & Sons
  • Release : 29 August 2013
GET THIS BOOKBiological Drug Products

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 a single resource that sets forth the fundamentalsas well as tested and proven development strategies for biologicaldrugs. Moreover, the book prepares readers for the challenges thattypically arise during drug development,

Rare Diseases and Orphan Products

Rare Diseases and Orphan Products
  • Author : Institute of Medicine,Board on Health Sciences Policy,Committee on Accelerating Rare Diseases Research and Orphan Product Development
  • Publisher : National Academies Press
  • Release : 03 April 2011
GET THIS BOOKRare Diseases and Orphan Products

Rare diseases collectively affect millions of Americans of all ages, but developing drugs and medical devices to prevent, diagnose, and treat these conditions is challenging. The Institute of Medicine (IOM) recommends implementing an integrated national strategy to promote rare diseases research and product development.

Characterization of Protein Therapeutics using Mass Spectrometry

Characterization of Protein Therapeutics using Mass Spectrometry
  • Author : Guodong Chen
  • Publisher : Springer Science & Business Media
  • Release : 08 July 2014
GET THIS BOOKCharacterization of Protein Therapeutics using Mass Spectrometry

This book highlights current approaches and future trends in the use of mass spectrometry to characterize protein therapies. As one of the most frequently utilized analytical techniques in pharmaceutical research and development, mass spectrometry has been widely used in the characterization of protein therapeutics due to its analytical sensitivity, selectivity, and specificity. This book begins with an overview of mass spectrometry techniques as related to the analysis of protein therapeutics, structural identification strategies, quantitative approaches, followed by studies involving characterization