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Therapeutic Protein Drug Products

Therapeutic Protein Drug Products
Practical Approaches to formulation in the Laboratory, Manufacturing, and the Clinic

by Brian K Meyer

  • Publisher : Elsevier
  • Release : 2012-01-02
  • Pages : 200
  • ISBN : 1908818107
  • Language : En, Es, Fr & De
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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

Therapeutic Proteins

Therapeutic Proteins
Methods and Protocols

by C. Mark Smales,David C. James

  • Publisher : Humana Press
  • Release : 2014-12-02
  • Pages : 482
  • ISBN : 9781627038485
  • Language : En, Es, Fr & De
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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 the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Biophysics for Therapeutic Protein Development

Biophysics for Therapeutic Protein Development
A Book

by Linda O. Narhi

  • Publisher : Springer Science & Business Media
  • Release : 2013-02-26
  • Pages : 293
  • ISBN : 1461443164
  • Language : En, Es, Fr & De
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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.

Particles in Therapeutic Protein Formulations

Particles in Therapeutic Protein Formulations
Relevance to Air-water and Silicone Oil-water Interfaces

by Pinaki Basu

  • Publisher : Unknown Publisher
  • Release : 2014
  • Pages : 108
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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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 sub-visible particles in therapeutic protein drug products has significantly increased due to its potential of eliciting an adverse immunogenic response. Consequently, evaluating the source and level of sub-visible particles in therapeutic protein drug products is important. In the studies that comprise my thesis, it was found that agitation of therapeutic protein formulations in the presence of siliconized beads accelerated the formation of sub-visible particles. Perturbation of the tertiary structure of therapeutic protein resulted from adsorption at the silicone oil-water interface. The addition of excipients, such as sucrose and sodium chloride, reduced tertiary structural changes. Lastly we found that rupturing the therapeutic protein layer at the air-water or silicone oil-water interface(s) accelerated the formation of sub-visible particles in therapeutic protein formulations. Overall, the work described in this thesis demonstrates that assessment of sub-visible particles in therapeutic protein formulations advances our understanding of therapeutic protein stability in the presence of silicone oil droplets/siliconized interfaces.

Therapeutic Proteins

Therapeutic Proteins
Methods and Protocols

by C. Mark Smales,David C. James

  • Publisher : Humana Press
  • Release : 2005-08-15
  • Pages : 482
  • ISBN : 9781588293909
  • Language : En, Es, Fr & De
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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 the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Lyophilized Biologics and Vaccines

Lyophilized Biologics and Vaccines
Modality-Based Approaches

by Dushyant Varshney,Manmohan Singh

  • Publisher : Springer
  • Release : 2015-05-19
  • Pages : 401
  • ISBN : 1493923838
  • Language : En, Es, Fr & De
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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 drying technology, to latest regulatory, packaging and technology transfer considerations to develop a stable, safe and effective therapeutic protein, vaccine and biotechnology products. Lyophilized Biologics and Vaccines: Modality-Based Approaches is composed of four sections with a total of 17 chapters. It serves as a reference to all critical assessments and steps from early pre-formulation stages to product launch: Provides recent understanding of heterogeneity of protein environment and selection of appropriate buffer for stabilization of lyophilized formulations Details the latest developments in instrumental analysis and controlled ice nucleation technology Explains in-depth lyophilized (or dehydrated) formulation strategies considering diverse modalities of biologics and vaccines, including plasmid DNA and lipid-based therapeutics Details an exhaustive update on quality-by-design and process analytical technology approaches, illustrated superbly by case studies and FDA perspective Provides the latest detailed account of alternate drying technologies including spray drying, bulk freeze-drying and crystallization, supported exceptionally by case studies Provides a step-by-step guide through critical considerations during process scale-up, technology transfer, packaging and drug delivery device selection, for a successful lyophilization process validation, regulatory submission and product launch Chapters are written by one or more world-renowned leading authorities from academia, industry or regulatory agencies, whose expertise cover lyophilization of the diverse modalities of biopharmaceuticals. Their contributions are based on the exhaustive review of literature coupled with excellent hands-on experiences in laboratory or GMP setup, making this an exceptional guide to all stages of lyophilized or dehydrated product development.

Therapeutic Proteins

Therapeutic Proteins
Methods and Protocols

by C. Mark Smales,David C. James

  • Publisher : Humana
  • Release : 2005-08-15
  • Pages : 482
  • ISBN : 9781588293909
  • Language : En, Es, Fr & De
GET BOOK

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 the road to development is the production of sufficient authentic material for testing, charact- ization, clinical trials, and so on. If a protein drug does actually make it through this lengthy and costly process, methodology that allows the production of the protein on a scale large enough to meet demand must be implemented. Furthermore, large-scale production must not compromise the authenticity of the final product. It is also nec- sary to have robust methods for the purification, characterization, viral inactivation and continued testing of the authenticity of the final protein product and to be able to formulate it in a manner that retains both its biological activity and lends itself to easy administration. Therapeutic Proteins: Methods and Protocols covers all aspects of protein drug production downstream of the discovery stage. This volume contains contributions from leaders in the field of therapeutic protein expression, purification, characterization, f- mulation, and viral inactivation.

Aggregation of Therapeutic Proteins

Aggregation of Therapeutic Proteins
A Book

by Wei Wang,Christopher J. Roberts

  • Publisher : John Wiley & Sons
  • Release : 2010-12-28
  • Pages : 484
  • ISBN : 9781118043585
  • Language : En, Es, Fr & De
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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.

Handbook of Biogeneric Therapeutic Proteins

Handbook of Biogeneric Therapeutic Proteins
Regulatory, Manufacturing, Testing, and Patent Issues

by Sarfaraz K. Niazi

  • Publisher : CRC Press
  • Release : 2002-08-15
  • Pages : 584
  • ISBN : 1000611329
  • Language : En, Es, Fr & De
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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 the regulato

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition

Pharmaceutical Formulation Development of Peptides and Proteins, Second Edition
A Book

by Lars Hovgaard,Sven Frokjaer,Marco van de Weert

  • Publisher : CRC Press
  • Release : 2012-11-14
  • Pages : 392
  • ISBN : 1439853886
  • Language : En, Es, Fr & De
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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 biotechnological production of proteins through recombinant DNA technology The physicochemical characteristics and stability of peptides and proteins The formulation of proteins as suspensions, solutions, and (mostly freeze-dried) solids The opportunities and challenges of non-parenteral delivery of peptides and proteins Risk factors, specifically the development of an unwanted immune response A simulation approach to describe the fate of peptides and proteins upon administration to a biological system The documentation required to register a protein-based drug Scientists in the pharmaceutical industry and academia as well as postgraduate students in pharmaceutical science will find this a valuable resource.

Challenges in Protein Product Development

Challenges in Protein Product Development
A Book

by Nicholas W. Warne,Hanns-Christian Mahler

  • Publisher : Springer
  • Release : 2018-07-22
  • Pages : 599
  • ISBN : 3319906038
  • Language : En, Es, Fr & De
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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.

Monoclonal Antibodies

Monoclonal Antibodies
Meeting the Challenges in Manufacturing, Formulation, Delivery and Stability of Final Drug Product

by Steven Shire

  • Publisher : Woodhead Publishing
  • Release : 2015-04-24
  • Pages : 224
  • ISBN : 0081002971
  • Language : En, Es, Fr & De
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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 of biophysical methods combined with genetic engineering is used to understand the solution properties of the formulation. The latter has become very important since many indications such as arthritis and asthma require the development of formulations for subcutaneous delivery (SC). The development of formulations for IV delivery is also important and comes with a different set of challenges. The challenges and strategies that can overcome these limitations are discussed in this book, starting with an introduction to these issues, followed by chapters detailing strategies to deal with them. Subsequent chapters explore the processing and storage of mAbs, development of delivery device technologies and conclude with a chapter on the future of mAbs in therapeutic remedies. Discusses the challenges to develop MAbs for intravenous (IV) and subcutaneous delivery (SC) Presents strategies to meet the challenges in development of MAbs for SC and IV administration Discusses the use of biophysical analytical tools coupled with MAb engineering to understand what governs MAb properties at high concentration

Therapeutic Proteins

Therapeutic Proteins
Methods and Protocols

by C. Mark Smales,David Cameron James

  • Publisher : Springer Science & Business Media
  • Release : 2005
  • Pages : 482
  • ISBN : 1592599222
  • Language : En, Es, Fr & De
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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.

Biological Drug Products

Biological Drug Products
Development and Strategies

by Wei Wang,Manmohan Singh

  • Publisher : John Wiley & Sons
  • Release : 2013-08-29
  • Pages : 744
  • ISBN : 1118695224
  • Language : En, Es, Fr & De
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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, offering straightforwardsolutions to improve their ability to pass through all theregulatory hurdles and deliver new drug products to the market. Biological Drug Products begins with generalconsiderations for the development of any biological drug productand then explores the strategies and challenges involved in thedevelopment of specific types of biologics. Divided into fiveparts, the book examines: Part 1: General Aspects Part 2: Proteins and Peptides Part 3: Vaccines Part 4: Novel Biologics Part 5: Product Administration/Delivery Each chapter has been prepared by one or more leading experts inbiological drug development. Contributions are based on acomprehensive review and analysis of the current literature as wellas the authors' first-hand experience developing and testing newdrugs. References at the end of each chapter serve as a gateway tooriginal research papers and reviews in the field. By incorporating lessons learned and future directions forresearch, Biological Drug Products enables pharmaceuticalscientists and students to improve their success rate in developingnew biologics to treat a broad range of human diseases.

Continuous Biopharmaceutical Processes

Continuous Biopharmaceutical Processes
Chromatography, Bioconjugation, and Protein Stability

by David Pfister,Lucrèce Nicoud,Massimo Morbidelli

  • Publisher : Cambridge University Press
  • Release : 2018-10-31
  • Pages : 129
  • ISBN : 1108349781
  • Language : En, Es, Fr & De
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This innovative reference provides a coherent and critical view on the potential benefits of a transition from batch to continuous processes in the biopharmaceutical industry, with the main focus on chromatography. It also covers the key topics of protein stability and protein conjugation, addressing the chemical reaction and purification aspects together with their integration. This book offers a fine balance between theoretical modelling and illustrative case studies, between fundamental concepts and applied examples from the academic and industrial literature. Scientists interested in the design of biopharmaceutical processes will find useful practical methodologies, in particular for single-column and multi-column chromatographic processes.

Biotechnology and Biopharmaceuticals

Biotechnology and Biopharmaceuticals
Transforming Proteins and Genes into Drugs

by Anonim

  • Publisher : John Wiley & Sons
  • Release : 2013-09-19
  • Pages : 744
  • ISBN : 1118659988
  • Language : En, Es, Fr & De
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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.

Protein Instability at Interfaces During Drug Product Development

Protein Instability at Interfaces During Drug Product Development
Fundamental Understanding, Evaluation, and Mitigation

by Jinjiang Li,Mary E. Krause,Raymond Tu

  • Publisher : Springer Nature
  • Release : 2021-02-12
  • Pages : 338
  • ISBN : 3030571777
  • Language : En, Es, Fr & De
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Proteins are exposed to various interfacial stresses during drug product development. They are subjected to air-liquid, liquid-solid, and, sometimes, liquid-liquid interfaces throughout the development cycle-from manufacturing of drug substances to storage and drug delivery. Unlike small molecule drugs, proteins are typically unstable at interfaces where, on adsorption, they often denature and form aggregates, resulting in loss of efficacy and potential immunogenicity. This book covers both the fundamental aspects of proteins at interfaces and the quantification of interfacial behaviors of proteins. Importantly, this book introduces the industrial aspects of protein instabilities at interfaces, including the processes that introduce new interfaces, evaluation of interfacial instabilities, and mitigation strategies. The audience that this book targets encompasses scientists in the pharmaceutical and biotech industry, as well as faculty and students from academia in the surface science, pharmaceutical, and medicinal chemistry areas.

Subvisible Particles in Therapeutic Protein Products and Potential Biological Consequences

Subvisible Particles in Therapeutic Protein Products and Potential Biological Consequences
A Book

by Neha Pardeshi

  • Publisher : Unknown Publisher
  • Release : 2016
  • Pages : 117
  • ISBN : 9876543210XXX
  • Language : En, Es, Fr & De
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Therapeutic proteins offer treatment options for a variety of chronic medical conditions including cancer, diabetes, rheumatoid arthritis etc. However, all therapeutic proteins have an inherent potential to cause immune responses. Moreover, product quality attributes like protein aggregates even in low concentration are implicated in eliciting an immune response. Specifically proteinaceous particles in the size range of few nm-μm even in significant concentrations represent less than 0.1% of the total protein in solution. These particles can form during any stage of drug product development from purification, storage, fill-finish operations to even delivery to patients. Hence it’s a challenge to keep the concentration of particles in solution at a minimum. Presently particles in the size range of 2-100 μm are routinely monitored. In this work, we have evaluated particles smaller than 2 μm for their contribution to the formation of larger micron sized particles upon exposure of the protein to various pharmaceutically relevant stress conditions. Thereafter we determined particle concentrations that may inadvertently be delivered to patients, during an IV infusion of a therapeutic protein and further evaluated the factors contributing to these particles. Lastly, we examined the biological consequences of administering these particles during IV infusion of therapeutic proteins. Towards this we monitored the activation of various processes of the innate and adaptive immune system such as cytokine release in whole blood, activation of the toll-like receptors, upregulation of dendritic cells and T cell proliferation in response to particle enriched or particle free fractions of IV solution of infliximab – a therapeutic antibody prescribed for numerous indications including Crohn’s disease and rheumatoid arthritis.

Stability and Characterization of Protein and Peptide Drugs

Stability and Characterization of Protein and Peptide Drugs
Case Histories

by Rodney Pearlman,Y. John Wang

  • Publisher : Springer Science & Business Media
  • Release : 2013-06-29
  • Pages : 353
  • ISBN : 1489912363
  • Language : En, Es, Fr & De
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This is the first volume to make available specific case histories of therapeutic proteins and peptides that have been marketed or are currently under clinical testing. The editors have selected a wide range of molecules derived from monoclonal antibodies, recombinant DNA, and natural and chemical sources to provide formulation scientists with practical examples of the deveopment of pharmaceutical products.

Analytical Ultracentrifugation

Analytical Ultracentrifugation
Instrumentation, Software, and Applications

by Susumu Uchiyama,Fumio Arisaka,Walter F. Stafford,Tom Laue

  • Publisher : Springer
  • Release : 2016-05-13
  • Pages : 532
  • ISBN : 443155985X
  • Language : En, Es, Fr & De
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This book introduces analytical ultracentrifugation (AUC) as a whole, covering essential theoretical and practical aspects as well as its applications in both biological and non-biological systems. Comprehensive characterizations of macromolecules in a solution are now routinely required not only for understanding the solution system but also for producing a solution with better properties. Analytical ultracentrifugation is one of most powerful and reliable techniques for studying the biophysical behavior of solutes in solution. In the last few years, there have been steady advances made in hardware, software, and applications for AUC. This book provides chapters that cover everything essential for beginners to the most advanced users and also offer updated knowledge of the field on advances in hardware, software, and applications. Recent development of hardware described in this book covers new detection systems that give added dimensions to AUC. Examples of data analysis with essential theoretical explanations for advanced and recently updated software are also introduced. Besides AUC of biological systems including membrane proteins and biopharmaceuticals, AUC applications for non-biological questions are included. AUC studies under non-ideal conditions such as highly concentrated solutions and solutions with high salt concentration are also included. The contributors to this book are leading researchers in the fields of solution biophysics and physical chemistry who extensively employ AUC analysis for their research. From this published work, one can gain new and comprehensive knowledge of recent AUC analysis.