Biophysical Characterization Of Proteins In Developing Biopharmaceuticals

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals

Damian J. Houde,Steven A. Berkowitz
Biophysical Characterization of Proteins in Developing Biopharmaceuticals Book PDF

Author : Damian J. Houde,Steven A. Berkowitz
Publisher : Elsevier
Page : 586 pages
File Size : 51,8 Mb
Release : 2019-11-13
Category : Medical
ISBN : 9780444641748

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Biophysical Characterization of Proteins in Developing Biopharmaceuticals by Damian J. Houde,Steven A. Berkowitz Pdf

Biophysical Characterization of Proteins in Developing Biopharmaceuticals, Second Edition, presents the latest on the analysis and characterization of the higher-order structure (HOS) or conformation of protein based drugs. Starting from the very basics of protein structure, this book explains the best way to achieve this goal using key methods commonly employed in the biopharmaceutical industry. This book will help today’s industrial scientists plan a career in this industry and successfully implement these biophysical methodologies. This updated edition has been fully revised, with new chapters focusing on the use of chromatography and electrophoresis and the biophysical characterization of very large biopharmaceuticals. In addition, best practices of applying statistical analysis to biophysical characterization data is included, along with practical issues associated with the concept of a biopharmaceutical’s developability and the technical decision-making process needed when dealing with biophysical characterization data. Presents basic protein characterization methods and tools applicable to (bio)pharmaceutical research and development Highlights the capabilities and limitations of each technique Discusses the underlining science of each tool Empowers industrial biophysical chemists by providing a roadmap for applying biophysical tools Outlines the needs for new characterization and analytical tools in the biopharmaceutical industry

Biophysics for Therapeutic Protein Development

Linda O. Narhi
Biophysics for Therapeutic Protein Development Book PDF

Author : Linda O. Narhi
Publisher : Springer Science & Business Media
Page : 299 pages
File Size : 42,8 Mb
Release : 2013-02-26
Category : Medical
ISBN : 9781461443162

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Biophysics for Therapeutic Protein Development by Linda O. Narhi Pdf

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.

Biophysical Methods for Biotherapeutics

Tapan K. Das
Biophysical Methods for Biotherapeutics Book PDF

Author : Tapan K. Das
Publisher : John Wiley & Sons
Page : 376 pages
File Size : 40,5 Mb
Release : 2014-02-27
Category : Medical
ISBN : 9781118354681

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Biophysical Methods for Biotherapeutics by Tapan K. Das Pdf

With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development. • Helps formulation and analytical scientists in pharma and biotech better understand and use biophysical methods • Chapters organized according to the sequential nature of the drug development process • Helps formulation, analytical, and bioanalytical scientists in pharma and biotech better understand and usestrengths and limitations of biophysical methods • Explains how to use biophysical methods, the information obtained, and what needs to be presented in a regulatory filing, assess impact on quality and immunogenicity • With a focus on practical applications of biophysical techniques, this book links fundamental biophysics to the process of biopharmaceutical development.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Feroz Jameel,Susan Hershenson
Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals Book PDF

Author : Feroz Jameel,Susan Hershenson
Publisher : John Wiley & Sons
Page : 986 pages
File Size : 52,6 Mb
Release : 2010-07-13
Category : Science
ISBN : 9780470595879

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Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals by Feroz Jameel,Susan Hershenson Pdf

A real-world guide to the production and manufacturing of biopharmaceuticals While much has been written about the science of biopharmaceuticals, there is a need for practical, up-to-date information on key issues at all stages of developing and manufacturing commercially viable biopharmaceutical drug products. This book helps fill the gap in the field, examining all areas of biopharmaceuticals manufacturing, from development and formulation to production and packaging. Written by a group of experts from industry and academia, the book focuses on real-world methods for maintaining product integrity throughout the commercialization process, clearly explaining the fundamentals and essential pathways for all development stages. Coverage includes: Research and early development phase appropriate approaches for ensuring product stability Development of commercially viable formulations for liquid and lyophilized dosage forms Optimal storage, packaging, and shipping methods Case studies relating to therapeutic monoclonal antibodies, recombinant proteins, and plasma fractions Useful analysis of successful and failed products Formulation and Process Development Strategies for Manufacturing Biopharma-ceuticals is an essential resource for scientists and engineers in the pharmaceutical and biotech industries, for government and regulatory agencies, and for anyone with an interest in the latest developments in the field.

Physical Methods to Characterize Pharmaceutical Proteins

James N. Herron,Wim Jiskoot,Daan J.A. Crommelin
Physical Methods to Characterize Pharmaceutical Proteins Book PDF

Author : James N. Herron,Wim Jiskoot,Daan J.A. Crommelin
Publisher : Springer
Page : 362 pages
File Size : 54,6 Mb
Release : 2013-06-06
Category : Medical
ISBN : 1489910816

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Physical Methods to Characterize Pharmaceutical Proteins by James N. Herron,Wim Jiskoot,Daan J.A. Crommelin Pdf

Proteins are still gaining importance in the pharmaceutical world, where they are used to improve our arsenal of therapeutic drugs and vaccines and as diagnostic tools. Proteins are different from "traditional" low-molecular-weight drugs. As a group, they exhibit a number of biopharmaceutical and formulation problems. These problems have drawn considerable interest from both industrial and aca demic environments, forcing pharmaceutical scientists to explore a domain previ ously examined only by peptide and protein chemists. Biopharmaceutical aspects of proteins, e.g., low oral bioavailability, have been extensively investigated. Although all possible conventional routes of ad ministration have been examined for proteins, no real, generally applicable alter native to parenteral administration in order to achieve systemic effects has yet been discovered. Several of these biopharmaceutical options have been discussed in Volume 4 of this series, Biological Barriers to Protein Delivery. Proteins are composed of many amino acids, several of which are notorious for their chemical instability. Rational design of formulations that optimize the native structure and/or bioactivity of a protein is therefore of great importance when long shelf life is required, as it is for pharmaceutical products. This issue has also been examined in two prior volumes of this series: Volume 2: Stability of Protein Pharmaceuticals (Part A) and Volume 5: Stability and Characterization of Protein and Peptide Drugs.

Biosimilar Drug Product Development

Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow
Biosimilar Drug Product Development Book PDF

Author : Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow
Publisher : CRC Press
Page : 379 pages
File Size : 45,7 Mb
Release : 2017-02-24
Category : Medical
ISBN : 9781351646185

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Biosimilar Drug Product Development by Laszlo Endrenyi,Dr. Paul Declerck,Shein-Chung Chow Pdf

When a biological drug patent expires, alternative biosimilar products are developed. The development of biosimilar products is complicated and involves numerous considerations and steps. The assessment of biosimilarity and interchangeability is also complicated and difficult. Biosimilar Drug Product Development presents current issues for the development of biosimilars and gives detailed reviews of its various stages and contributing factors as well as relevant regulatory pathways and pre- and post-approval issues.

Challenges in Protein Product Development

Nicholas W. Warne,Hanns-Christian Mahler
Challenges in Protein Product Development Book PDF

Author : Nicholas W. Warne,Hanns-Christian Mahler
Publisher : Springer
Page : 599 pages
File Size : 50,6 Mb
Release : 2018-06-20
Category : Medical
ISBN : 9783319906034

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Challenges in Protein Product Development by Nicholas W. Warne,Hanns-Christian Mahler Pdf

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 or by the demands placed on the product by stability, manufacturing and preclinical or clinical expectations, as well as the evolving regulatory expectations and landscape. Further, there have been new findings that require close assessment, as for example those related to excipient quality, processing, viscosity and device compatibility and administration, solubility and opalescence and container-closure selection. The literature varies widely in its discussion of these critical elements and consensus does not exist. This topic is receiving a great deal of attention within the biotechnology industry as well as with academic researchers and regulatory agencies globally. Therefore, this book is of interest for business leaders, researchers, formulation and process development scientists, analytical scientists, QA and QC officers, regulatory staff, manufacturing leaders and regulators active in the pharmaceutical and biotech industry, and expert reviewers in regulatory agencies.

State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization

John E. Schiel,Darryl L. Davis,Oleg V. Borisov,Oleg Borisov
State Of the Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2 Biopharmaceutical Characterization Book PDF

Author : John E. Schiel,Darryl L. Davis,Oleg V. Borisov,Oleg Borisov
Publisher : ACS Symposium
Page : 0 pages
File Size : 54,6 Mb
Release : 2016-06-24
Category : Medical
ISBN : 0841230293

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State-Of-the-Art and Emerging Technologies for Therapeutic Monoclonal Antibody Characterization Volume 2. Biopharmaceutical Characterization by John E. Schiel,Darryl L. Davis,Oleg V. Borisov,Oleg Borisov Pdf

"Distributed in print by Oxford University Press."

Hydrogen Exchange Mass Spectrometry of Proteins

David D. Weis
Hydrogen Exchange Mass Spectrometry of Proteins Book PDF

Author : David D. Weis
Publisher : John Wiley & Sons
Page : 376 pages
File Size : 44,8 Mb
Release : 2016-01-12
Category : Science
ISBN : 9781118703731

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Hydrogen Exchange Mass Spectrometry of Proteins by David D. Weis Pdf

Hydrogen exchange mass spectrometry is widely recognized for its ability to probe the structure and dynamics of proteins. The application of this technique is becoming widespread due to its versatility for providing structural information about challenging biological macromolecules such as antibodies, flexible proteins and glycoproteins. Although the technique has been around for 25 years, this is the first definitive book devoted entirely to the topic. Hydrogen Exchange Mass Spectrometry of Proteins: Fundamentals, Methods and Applications brings into one comprehensive volume the theory, instrumentation and applications of Hydrogen Exchange Mass Spectrometry (HX-MS) - a technique relevant to bioanalytical chemistry, protein science and pharmaceuticals. The book provides a solid foundation in the basics of the technique and data interpretation to inform readers of current research in the method, and provides illustrative examples of its use in bio- and pharmaceutical chemistry and biophysics In-depth chapters on the fundamental theory of hydrogen exchange, and tutorial chapters on measurement and data analysis provide the essential background for those ready to adopt HX-MS. Expert users may advance their current understanding through chapters on methods including membrane protein analysis, alternative proteases, millisecond hydrogen exchange, top-down mass spectrometry, histidine exchange and method validation. All readers can explore the diversity of HX-MS applications in areas such as ligand binding, membrane proteins, drug discovery, therapeutic protein formulation, biocomparability, and intrinsically disordered proteins.

Biologics, Biosimilars, and Biobetters

Iqbal Ramzan
Biologics Biosimilars and Biobetters Book PDF

Author : Iqbal Ramzan
Publisher : John Wiley & Sons
Page : 328 pages
File Size : 49,9 Mb
Release : 2021-02-03
Category : Medical
ISBN : 9781119564652

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Biologics, Biosimilars, and Biobetters by Iqbal Ramzan Pdf

A comprehensive primer and reference, this book provides pharmacists and health practitioners the relevant science and policy concepts behind biologics, biosimilars, and biobetters from a practical and clinical perspective. Explains what pharmacists need to discuss the equivalence, efficacy, safety, and risks of biosimilars with physicians, health practitioners, and patients about Guides regulators on pragmatic approaches to dealing with these drugs in the context of rapidly evolving scientific and clinical evidence Balances scientific information on complex drugs with practical information, such as a checklist for pharmacists

Analytical Characterization of Biotherapeutics

Jennie R. Lill,Wendy Sandoval
Analytical Characterization of Biotherapeutics Book PDF

Author : Jennie R. Lill,Wendy Sandoval
Publisher : John Wiley & Sons
Page : 368 pages
File Size : 52,5 Mb
Release : 2017-07-10
Category : Science
ISBN : 9781119384427

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Analytical Characterization of Biotherapeutics by Jennie R. Lill,Wendy Sandoval Pdf

The definitive guide to the myriad analytical techniques available to scientists involved in biotherapeutics research Analytical Characterization of Biotherapeutics covers all current and emerging analytical tools and techniques used for the characterization of therapeutic proteins and antigen reagents. From basic recombinant antigen and antibody characterization, to complex analyses for increasingly complex molecular designs, the book explores the history of the analysis techniques and offers valuable insights into the most important emerging analytical solutions. In addition, it frames critical questions warranting attention in the design and delivery of a therapeutic protein, exposes analytical challenges that may occur when characterizing these molecules, and presents a number of tested solutions. The first single-volume guide of its kind, Analytical Characterization of Biotherapeutics brings together contributions from scientists at the leading edge of biotherapeutics research and manufacturing. Key topics covered in-depth include the structural characterization of recombinant proteins and antibodies, antibody de novo sequencing, characterization of antibody drug conjugates, characterization of bi-specific or other hybrid molecules, characterization of manufacturing host-cell contaminant proteins, analytical tools for biologics molecular assessment, and more. Each chapter is written by a recognized expert or experts in their field who discuss current and cutting edge approaches to fully characterizing biotherapeutic proteins and antigen reagents Covers the full range of characterization strategies for large molecule based therapeutics Provides an up-to-date account of the latest approaches used for large molecule characterization Chapters cover the background needed to understand the challenges at hand, solutions to characterize these large molecules, and a summary of emerging options for analytical characterization Analytical Characterization of Biotherapeutics is an up-to-date resource for analytical scientists, biologists, and mass spectrometrists involved in the analysis of biomolecules, as well as scientists employed in the pharmaceuticals and biotechnology industries. Graduate students in biology and analytical science, and their instructors will find it to be fascinating and instructive supplementary reading.

Development of Biopharmaceutical Drug-Device Products

Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Development of Biopharmaceutical Drug Device Products Book PDF

Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
Publisher : Springer Nature
Page : 888 pages
File Size : 41,7 Mb
Release : 2020-03-13
Category : Medical
ISBN : 9783030314156

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Development of Biopharmaceutical Drug-Device Products by Feroz Jameel,John W. Skoug,Robert R. Nesbitt Pdf

The biotechnology/biopharmaceutical sector has tremendously grown which led to the invention of engineered antibodies such as Antibody Drug Conjugates (ADCs), Bispecific T-cell engager (BITES), Dual Variable Domain (DVD) antibodies, and fusion proteins that are currently being used as therapeutic agents for immunology, oncology and other disease conditions. Regulatory agencies have raised the bar for the development and manufacture of antibody-based products, expecting to see the use of Quality by Design (QbD) elements demonstrating an in-depth understanding of product and process based on sound science. Drug delivery systems have become an increasingly important part of the therapy and most biopharmaceuticals for self-administration are being marketed as combination products. A survey of the market indicates that there is a strong need for a new book that will provide “one stop shopping” for the latest information and knowledge of the scientific and engineering advances made over the last few years in the area of biopharmaceutical product development. The new book entitled Development of Biopharmaceutical Drug Device Products is a reference text for scientists and engineers in the biopharmaceutical industry, academia or regulatory agencies. With insightful chapters from experts in the field, this new book reviews first principles, covers recent technological advancements and provides case studies and regulatory strategies relating to the development and manufacture of antibody-based products. It covers topics such as the importance of early preformulation studies during drug discovery to influence molecular selection for development, formulation strategies for new modalities, and the analytical techniques used to characterize them. It also addresses important considerations for later stage development such as the development of robust formulations and processes, including process engineering and modeling of manufacturing unit operations, the design of analytical comparability studies, and characterization of primary containers (pre-filled syringes and vials).Finally, the latter half of the book reviews key considerations to ensure the development and approval of a patient-centered delivery system design. This involves the evolving regulatory framework with perspectives from both the US and EU industry experts, the role of international standards, design control/risk management, human factors and its importance in the product development and regulatory approval process, as well as review of the risk-based approach to bridging between devices used in clinical trials and the to-be-marketed device. Finally, case studies are provided throughout.The typical readership would have biology and/or engineering degrees and would include researchers, scientific leaders, industry specialists and technology developers working in the biopharmaceutical field.

Biotechnology and Biopharmaceuticals

Anonim
Biotechnology and Biopharmaceuticals Book PDF

Author : Anonim
Publisher : John Wiley & Sons
Page : 744 pages
File Size : 44,8 Mb
Release : 2013-12-16
Category : Science
ISBN : 9781118179796

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Biotechnology and Biopharmaceuticals by Anonim Pdf

Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Drying Technologies for Biotechnology and Pharmaceutical Applications

Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Drying Technologies for Biotechnology and Pharmaceutical Applications Book PDF

Author : Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros
Publisher : John Wiley & Sons
Page : 394 pages
File Size : 50,9 Mb
Release : 2020-06-02
Category : Medical
ISBN : 9783527341122

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Drying Technologies for Biotechnology and Pharmaceutical Applications by Satoshi Ohtake,Ken-ichi Izutsu,David Lechuga-Ballesteros Pdf

A comprehensive source of information about modern drying technologies that uniquely focus on the processing of pharmaceuticals and biologicals Drying technologies are an indispensable production step in the pharmaceutical industry and the knowledge of drying technologies and applications is absolutely essential for current drug product development. This book focuses on the application of various drying technologies to the processing of pharmaceuticals and biologicals. It offers a complete overview of innovative as well as standard drying technologies, and addresses the issues of why drying is required and what the critical considerations are for implementing this process operation during drug product development. Drying Technologies for Biotechnology and Pharmaceutical Applications discusses the state-of-the-art of established drying technologies like freeze- and spray- drying and highlights limitations that need to be overcome to achieve the future state of pharmaceutical manufacturing. The book also describes promising next generation drying technologies, which are currently used in fields outside of pharmaceuticals, and how they can be implemented and adapted for future use in the pharmaceutical industry. In addition, it deals with the generation of synergistic effects (e.g. by applying process analytical technology) and provides an outlook toward future developments. -Presents a full technical overview of well established standard drying methods alongside various other drying technologies, possible improvements, limitations, synergies, and future directions -Outlines different drying technologies from an application-oriented point of view and with consideration of real world challenges in the field of drug product development -Edited by renowned experts from the pharmaceutical industry and assembled by leading experts from industry and academia Drying Technologies for Biotechnology and Pharmaceutical Applications is an important book for pharma engineers, process engineers, chemical engineers, and others who work in related industries.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

John Geigert
The Challenge of CMC Regulatory Compliance for Biopharmaceuticals Book PDF

Author : John Geigert
Publisher : Springer
Page : 426 pages
File Size : 54,7 Mb
Release : 2019-05-08
Category : Medical
ISBN : 9783030137540

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The Challenge of CMC Regulatory Compliance for Biopharmaceuticals by John Geigert Pdf

Biopharmaceuticals (i.e., biological medicines sourced from genetically-engineered living systems) for treatment of human diseases have become a significant percentage of the pharmaceutical industry. And not just the recombinant DNA-derived proteins and monoclonal antibodies (both from the innovators and biosimilars); but now, an increasing awareness of the importance of gene therapy and genetically engineered cellular medicinal products. These biopharmaceuticals are being developed by many companies whose Chemistry, Manufacturing & Control (CMC) teams have varying degrees of familiarity or experience with the CMC strategy and regulatory compliance requirements for these challenging products. Companies clearly plan out the strategy for their clinical study plans, but frequently, the development of a strategy for CMC is an afterthought. Coupled with the complexity of the biopharmaceutical manufacturing processes and products, and this can be a recipe for disaster. The third edition of this book provides insights and practical guidance for the CMC teams to develop an acceptable cost-effective, risk-based CMC regulatory compliance strategy for all biopharmaceuticals (recombinant proteins, monoclonal antibodies, genetically engineered viruses and genetically engineered human cells) from early clinical stage development through market approval. The third edition of this book provides added coverage for the biosimilars, antibody drug conjugates (ADCs), bispecific antibodies, genetically engineered viruses, and genetically engineered cells. This third edition of the book also addresses the heightened pressure on CMC regulatory compliance timelines due to the introduction of expedited clinical pathways moving the clinical development closer to a seamless phase process (e.g., FDA Breakthrough Therapy designation, CBER Regenerative Medicine Advanced Therapy (RMAT) designation, EMA Priority Medicines (PRIME) designation). The Challenge of CMC Regulatory Compliance for Biopharmaceuticals is essential, practical information for all pharmaceutical development scientists, Manufacturing and Quality Unit staff, Regulatory Affairs personnel, and senior management involved in the manufacture of biopharmaceuticals.