Therapeutic Proteins

Therapeutic Proteins

Once a potential protein drug has been identified, the next rate-limiting step on
the road to development is the production of sufficient ... Therapeutic Proteins:
Methods and Protocols covers all aspects of protein drug production downstream
 ...

Author: C. Mark Smales

Publisher: Springer Science & Business Media

ISBN: 9781592599226

Category: Medical

Page: 482

View: 860

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 expression systems, insect and mammalian cells. Therapeutic Proteins: Methods and Protocols will prove an invaluable resourse to all those working in the field of therapeutic protein production.
Categories: Medical

Production of Therapeutic Proteins in Plants

Production of Therapeutic Proteins in Plants

Nonetheless, plant expression systems can potentially produce hundreds of
kilograms per year of a purified protein ... THERAPEUTIC PROTEINS Antibodies
Passive immunizations using monoclonal antibodies are the ANR Publication
8078 ...

Author:

Publisher: UCANR Publications

ISBN: 9781601072542

Category:

Page:

View: 839

Categories:

Novel Therapeutic Proteins

Novel Therapeutic Proteins

Proteins Selected Case Studies Edited by Klaus Dembowsky and Peter Stadler
WILEY-VCH Weinheim - New York - 'chester Brisbane - Singapore - nto This
Page Intentionally Left Blank Selected Case Studies Edited by Novel Therapeutic
 ...

Author: Klaus Dembowsky

Publisher: John Wiley & Sons

ISBN: 9783527613038

Category: Science

Page: 382

View: 118

This book describes medical applications of recombinant proteins and monoclonal antibodies, some of which have already been on the market for several years while others have only recently been launched. It also highlights the manufacturing processes for individual products, the strategies that were taken by companies in the clinical development, and the hurdles that were encountered in clinical trials and had to be overcome before approval by regulatory authorities. Finally, this book illustrates strategies to modify and improve the pharmacodynamic and pharmacokinetic properties of naturally occurring proteins thus paving the way for a new era in biotechnology. Foreword written by Jürgen Drews.
Categories: Science

Therapeutic Proteins

Therapeutic Proteins

Roland E. Kontermann 1.1 Therapeutic Proteins With roughly 200 biologics
approved for therapeutic applications and more than 600 under clinical
development [1], biotechnology products cover an increased proportion of all
therapeutic ...

Author: Roland Kontermann

Publisher: John Wiley & Sons

ISBN: 9783527644780

Category: Science

Page: 372

View: 174

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.
Categories: Science

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins

RAHUL S. RAJAN, TIANSHENG LI, and TSUTOMU ARAKAWA 9.1
INTRODUCTION Protein aggregation is a complex degradation ... diseases has
been an intense area of research,4–6 with the ultimate goal of developing a
therapeutic drug.

Author: Wei Wang

Publisher: John Wiley & Sons

ISBN: 1118043588

Category: Medical

Page: 484

View: 465

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 investigations in this area. This book fills such a need by providing an overview on the causes, consequences, characterization, and control of the aggregation of therapeutic proteins.
Categories: Medical

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases

Quantitative Pharmacology and Individualized Therapy Strategies in Development of Therapeutic Proteins for Immune Mediated Inflammatory Diseases

In addition, personalized medicine represents a new treatment paradigm for
therapeutic proteins, and more than 20% of all new molecular entities approved
by FDA in 2016 were classified as personalized medicines and rely on DNA-
based ...

Author: Honghui Zhou

Publisher: Wiley

ISBN: 9781119289197

Category: Medical

Page: 496

View: 864

Thorough Overview Identifies and Addresses Critical Gaps in the Treatment of Several Chronic Diseases With increasing numbers of patients suffering from Immune-Mediated Inflammatory Diseases (IMIDs), and with the increasing reliance on biopharmaceuticals to treat them, it is imperative that researchers and medical practitioners have a thorough understanding of the absorption, distribution, metabolism and excretion (ADME) of therapeutic proteins as well as translational pharmacokinetic/pharmacodynamic (PK/PD) modeling for them. This comprehensive volume answers that need to be addressed. Featuring eighteen chapters from world-renowned experts and opinion leaders in pharmacology, translational medicine and immunology, editors Honghui Zhou and Diane Mould have curated a much-needed collection of research on the advanced applications of pharmacometrics and systems pharmacology to the development of biotherapeutics and individualized treatment strategies for the treatment of IMIDs. Authors discuss the pathophysiology of autoimmune diseases in addition to both theoretical and practical aspects of quantitative pharmacology for therapeutic proteins, current translational medicine research methodologies and novel thinking in treatment paradigm strategies for IMIDs. Other notable features include: • Contributions from well-known authors representing leading academic research centers, specialized contract research organizations and pharmaceutical industries whose pipelines include therapeutic proteins • Chapters on a wide range of topics (e.g., pathophysiology of autoimmune diseases, biomarkers in ulcerative colitis, model-based meta-analysis use in the development of therapeutic proteins) • Case studies of applying quantitative pharmacology approaches to guiding therapeutic protein drug development in IMIDs such as psoriasis, inflammatory bowel disease, multiple sclerosis and lupus Zhou and Mould’s timely contribution to the critical study of biopharmaceuticals is a valuable resource for any academic and industry researcher working in pharmacokinetics, pharmacology, biochemistry, or biotechnology as well as the many clinicians seeking the safest and most effective treatments for patients dealing with chronic immune disorders.
Categories: Medical

Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches

Considerations for Ensuring Safety and Efficacy of Vaccines and Therapeutic Proteins Manufactured by Using Platform Approaches

... components of manufacturing that aim to reduce both development time and
risk of vaccines and therapeutic proteins (e.g., monoclonal antibodies) targeted at
specific agents within a few months after these agents are identified. This is ...

Author: National Research Council

Publisher: National Academies Press

ISBN: 9780309153218

Category: Medical

Page: 38

View: 128

A major goal of the US Department of Defense (DOD) Transformational Medical Technologies Initiative (TMTI) is to develop countermeasures that will protect military personnel against bioweapons, including specific infectious-disease agents and toxins. An explicit TMTI objective is to respond quickly to such threats by producing an appropriate amount of an effective countermeasure--currently defined as enough material to treat or vaccinate 3 million personnel--within 12 months of identification of a specific threat. DOD officials call for TMTI programs to be up and running by 2014. The National Academies hosted a workshop which brought together scientists from academe, government, and the biotechnology industry to identify and discuss challenges and ideas related to the TMTI's vision of developing countermeasures within a few months after an agent is identified. The workshop focused on manufacturing processes and specifically on the development of "manufacturing platforms"--repeatable components of manufacturing that reduce both development time and risk. An underlying assumption was that demonstrating that integrated platforms can reliably produce safe and efficacious countermeasures might shorten the regulatory approval process. The workshop is summarized in this book.
Categories: Medical

Mammary Gland Transgenesis Therapeutic Protein Production

Mammary Gland Transgenesis  Therapeutic Protein Production

Therapeutic. Proteins. William H. Velander, James W. Knight and Francis C.
Gwazdauskas Sourcing Issues for Therapeutic Proteins While transgenesis in
livestock can be used to improve animal productivity, we here review the salient ...

Author: Fidel O. Castro

Publisher: Springer Science & Business Media

ISBN: 3540637125

Category: Science

Page: 222

View: 933

This book presents the latest in mammary gland transgenesis, the exploitation of transgenic technology for the production of therapeutic proteins by routine or conventional methods. Following a section with an overview of all relevant methodologies, readers will find relevant information on the regulation of milk gene expression and bioreactor species such as cattle, rabbits and pigs.
Categories: Science

Challenges in the Pharmacokinetics of Therapeutic Proteins

Challenges in the Pharmacokinetics of Therapeutic Proteins

In summary, the findings in this dissertation have pointed out the weakness of the classical bioavailability estimation for protein drugs that undergo TMDD and have determined the factors that should be considered for dose adjustments of ...

Author: Wararat Limothai

Publisher:

ISBN: OCLC:1066115919

Category:

Page:

View: 633

In summary, the findings in this dissertation have pointed out the weakness of the classical bioavailability estimation for protein drugs that undergo TMDD and have determined the factors that should be considered for dose adjustments of therapeutic mAbs in different-aged populations.
Categories:

Therapeutic Protein Drug Products

Therapeutic Protein Drug Products

Previously, Dr Meyer's team was responsible for formulating therapeutic proteins
in pre-clinical development. Prior to joining MRL, Dr Meyer was a Process
Scientist in Vaccine Technology and Engineering, Merck Manufacturing Division.

Author: Brian K Meyer

Publisher: Elsevier

ISBN: 9781908818102

Category: Medical

Page: 200

View: 889

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
Categories: Medical

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development

Introduction. Linda 0. Narhi The last few decades have seen the evolution of
protein therapeutics, from a few drugs isolated from natural sources (such as
insulin) to numerous engineered molecules that are designed to target specific
diseases ...

Author: Linda O. Narhi

Publisher: Springer Science & Business Media

ISBN: 9781461443162

Category: Medical

Page: 293

View: 566

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 the focus is on identifying targets, and screening for potential drug product candidates, through expression and purification, large scale production, formulation development, lot-to-lot comparability studies, and commercial support including investigations.
Categories: Medical

Purification and Analysis of Recombinant Proteins

Purification and Analysis of Recombinant Proteins

2 Purification and Production of Therapeutic Grade Proteins Vipin K. Garg , *
Maureen A. C. Costello , and Barbara A. Czuba ? Bio - Response , Inc. Hayward ,
California 1. INTRODUCTION Purified proteins are being increasingly used for ...

Author: SEETHARAM

Publisher: CRC Press

ISBN: 0824782771

Category: Medical

Page: 344

View: 845

Covering both new and traditional topics in the purification and analysis of recombinant proteins, this volume demonstrates how to overcome problems in protein research and presents practical methods used in protein work, explaining their theoretical bases. The collection also explores innovative co
Categories: Medical

Biological Barriers to Protein Delivery

Biological Barriers to Protein Delivery

HEPATIC CLEARANCE OF THERAPEUTIC PROTEINS AND OLIGOPEPTIDES :
AN INTEGRATION OF CONCEPTS 6.1 . Chemical and Physiological Factors
Many potential therapeutic proteins are either under investigation or have been ...

Author: Kenneth L. Audus

Publisher: Springer Science & Business Media

ISBN: 0306443686

Category: Medical

Page: 495

View: 805

In response to the tremendous increase in the number of protein and peptide drugs, this treatise critically reviews transport and metabolism mechanisms relating to the delivery of endogenous and recombinant proteins to mammalian organs, tissues, and cells. It will promote fruitful collaboration among academic and industrial scientists in the fields of pharmacology, cell biology, biochemistry, physiology, and immunology.
Categories: Medical

Therapeutic Peptides and Proteins

Therapeutic Peptides and Proteins

At the time of writing, the American biotechnology and pharmaceutical industry
has more than two dozen biotechnology-derived therapeutic proteins on the
market, while several hundred are in various stages of human clinical trials or at
the ...

Author: Ajay K. Banga

Publisher: CRC Press

ISBN: 9781420039832

Category: Medical

Page: 376

View: 545

Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up
Categories: Medical

Misbehaving Proteins

Misbehaving Proteins

Therapeutic. Proteins. Implications. for. Product. Development. Mary E. M.
Cromwell,1,2 Chantal Felten,1 Heather Flores,1 Jun Liu,1 and Steven J. Shire1
Protein aggregation is typically thought of as a denaturation process that results
in the ...

Author: Regina Murphy

Publisher: Springer Science & Business Media

ISBN: 9780387360638

Category: Science

Page: 354

View: 901

This text provides an up-to-date collection of theoretical and experimental studies into protein folding, misfolding, aggregation, and stability. Additionally, issues faced during the development of protein products are illustrated. It contains an introductory chapter for readers new to the protein folding field. The book provides a thorough and clear discussion of computational approaches to understanding and modeling protein aggregation.
Categories: Science

Drug Drug Interactions for Therapeutic Biologics

Drug Drug Interactions for Therapeutic Biologics

As for all other drugs, any effect of therapeutic proteins on the metabolism of
other (victim) drugs needs to be tested and quantified. The main mechanisms of
interaction for small molecules on CYPs are enzyme inhibition by direct
interaction ...

Author: Honghui Zhou

Publisher: John Wiley & Sons

ISBN: 9781118630211

Category: Medical

Page: 378

View: 727

Strategize, plan, and execute comprehensive drug-druginteraction assessments for therapeutic biologics Offering both theory and practical guidance, this book fullyexplores drug-drug interaction assessments for therapeuticbiologics during the drug development process. It draws togetherand analyzes all the latest findings and practices in order topresent our current understanding of the topic and point the way tonew research. Case studies and examples, coupled with expertadvice, enable readers to better understand the complex mechanismsof biologic drug-drug interactions. Drug-Drug Interactions for Therapeutic Biologics featurescontributions from leading international experts in all areas oftherapeutic biologics drug development and drug-drug interactions.The authors' contributions reflect a thorough review and analysisof the literature as well as their own firsthand laboratoryexperience. Coverage includes such essential topics as: Drug-drug interaction risks in combination with small moleculesand other biologics Pharmacokinetic and pharmacodynamic drug-drug interactions In vitro methods for drug-drug interaction assessment andprediction Risk-based strategies for evaluating biologic drug-druginteractions Strategies to minimize drug-drug interaction risk and mitigatetoxic interactions Key regulations governing drug-drug interaction assessments fortherapeutic biologics. Drug-Drug Interactions for Therapeutic Biologics isrecommended for pharmaceutical and biotechnology scientists,clinical pharmacologists, medicinal chemists, and toxicologists. Byenabling these readers to understand how therapeutic biologics mayinteract with other drugs, the book will help them develop safer,more effective therapeutic biologics.
Categories: Medical

Basic Biotechnology

Basic Biotechnology

20.3 Therapeutic proteins Proteins are part of numerous traditional medicines ,
such as snake and bee venom and enzyme preparations but , in most cases ,
these are illdefined mixtures . Furthermore , naturally occurring proteins obtained
 ...

Author: Colin Ratledge

Publisher: Cambridge University Press

ISBN: 0521779170

Category: Medical

Page: 568

View: 258

Biotechnology: what it is, how it's used, and how you do it!
Categories: Medical

Molecular Biology of Protein Folding

Molecular Biology of Protein Folding

Proteins are highly specific and often potent, providing advantage over small
organic molecule as therapeutic agents. It is not surprising that the number of
proteintherapeutic drugs is increasing. Recombinant‐DNA technology has
allowed ...

Author: P. Michael Conn

Publisher: Academic Press

ISBN: 0080923380

Category: Science

Page: 288

View: 331

The importance of protein folding has been recognized for many years. It is the underlying etiology in a large number of human diseases and it appears to be a novel method for cellular regulation of the expression of newly translated proteins. These volumes (Parts A & B) address this important topic. As a volume in Progress in Nucleic Acid Research and Molecular Biology, this book provides the latest information on the expanding research being conducted on protein folding. *Follow the new editor-in-chief, P. Michael Conn, as he introduces this first thematic volume in the series – an in-depth aid to researchers who are looking for the best techniques and tools for understanding the complexities of protein folding *Understand the advantages of protein folding over other therapeutic approaches and see how protein folding plays a critical role in the development of diseases such as Alzheimer’s and diabetes *Decipher the rules of protein folding through compelling and timely reviews combined with chapters written by international authors in engineering, biochemistry, physics and computer science
Categories: Science

Production of Plasma Proteins for Therapeutic Use

Production of Plasma Proteins for Therapeutic Use

Evidence of efficacy of cryoprecipitation, PEG precipitation, and cold ethanol
precipitation procedures to remove PrP has been demonstrated in several
diverse human plasma therapeutic protein manufacturing processes [71–73].
Evidence of ...

Author: Joseph Bertolini

Publisher: John Wiley & Sons

ISBN: 9781118356791

Category: Medical

Page: 512

View: 830

Sets forth the state of the science and technology in plasma protein production With contributions from an international team of eighty leading experts and pioneers in the field, Production of Plasma Proteins for Therapeutic Use presents a comprehensive overview of the current state of knowledge about the function, use, and production of blood plasma proteins. In addition to details of the operational requirements for the production of plasma derivatives, the book describes the biology, development, research, manufacture, and clinical indications of essentially all plasma proteins with established clinical use or therapeutic potential. Production of Plasma Proteins for Therapeutic Use covers the key aspects of the plasma fractionation industry in five sections: Section 1: Introduction to Plasma Fractionation initially describes the history of transfusion and then covers the emergence of plasma collection and fractionation from its earliest days to the present time, with the commercial and not-for-profit sectors developing into a multi-billion dollar industry. Section 2: Plasma Proteins for Therapeutic Use contains 24 chapters dedicated to specific plasma proteins, including coagulation factors, albumin, immunoglobulin, and a comprehensive range of other plasma-derived proteins with therapeutic indications. Each chapter discusses the physiology, biochemistry, mechanism of action, and manufacture of each plasma protein including viral safety issues and clinical uses. Section 3: Pathogen Safety of Plasma Products examines issues and procedures for enhancing viral safety and reducing the risk of transmissible spongiform encephalopathy transmission. Section 4: The Pharmaceutical Environment Applied to Plasma Fractionation details the requirements and activities associated with plasma collection, quality assurance, compliance with regulatory requirements, provision of medical affairs support, and the manufacture of plasma products. Section 5: The Market for Plasma Products and the Economics of Fractionation reviews the commercial environment and economics of the plasma fractionation industry including future trends, highlighting regions such as Asia, which have the potential to exert a major influence on the plasma fractionation industry in the twenty-first century.
Categories: Medical

Transgenic Microalgae as Green Cell Factories

Transgenic Microalgae as Green Cell Factories

Recombinant proteins expressed in algae have the potential to provide novel
and safe treatment of disease and infection where current, high-cost drugs are
the only option, or worse, where therapeutic drugs are not available due to their ...

Author: Rosa León

Publisher: Springer Science & Business Media

ISBN: 9780387755328

Category: Science

Page: 131

View: 614

Microalgae have been largely commercialized as food and feed additives, and their potential as a source of high-added value compounds is well known. Yet, only a few species of microalgae have been genetically transformed with efficiency. A better understanding of the mechanisms that control the regulation of gene expression in eukaryotes is therefore needed. In this book a group of outstanding researchers working on different areas of microalgae biotechnology offer a global vision of the genetic manipulation of microalgae and their applications.
Categories: Science