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Formulation of Monoclonal Antibody Therapies

Formulation of Monoclonal Antibody Therapies
  • Author : Amal Ali Elkordy
  • Publisher :Unknown
  • Release Date :2021-10-15
  • Total pages :245
  • ISBN : 0128233656
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Summary : Formulation of Monoclonal Antibody Therapies: From Lab to Market covers a wide range of topics about therapeutic monoclonal antibodies (mAbs) with a focus on formulation aspects. Therapeutic monoclonal antibodies are used for treatment of chronic diseases. It brings together a comprehensive knowledge in one accessible volume. Starting with foundational information on monoclonal antibodies, the book then discusses the importance of biopharmaceutical products, monoclonal antibodies and biosimilars in treatment of chronic diseases, pharmaceutical aspects of mAbs, and how it can be administered. The industrial point of view and the clinical application of mAbs including in oncology, general medicine, rheumatology, hematology, dermatology, gastrointestinal tract, metabolic diseases and dentistry. Formulation of Monoclonal Antibody Therapies: From Lab to Market is essential reading for researchers in biotechnology and biopharmaceutical fields, academics and pharmaceutical industrial scientists, and university students in pharmaceutical and biopharmaceutical sciences. Covers details of recent advances in using mAbs Examines how to overcome the challenges for formulations of therapeutic mAbs Includes liposomal forms of mAbs

Monoclonal Antibodies

Monoclonal Antibodies
  • Author : Steven Shire
  • Publisher :Unknown
  • Release Date :2015-04-24
  • Total pages :224
  • ISBN : 9780081002971
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Summary : 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

Development of Biopharmaceutical Drug-Device Products

Development of Biopharmaceutical Drug-Device Products
  • Author : Feroz Jameel,John W. Skoug,Robert R. Nesbitt
  • Publisher :Unknown
  • Release Date :2020-03-13
  • Total pages :893
  • ISBN : 9783030314156
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Summary : 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.

Therapeutic Monoclonal Antibodies

Therapeutic Monoclonal Antibodies
  • Author : Zhiqiang An
  • Publisher :Unknown
  • Release Date :2011-09-20
  • Total pages :896
  • ISBN : 9781118210260
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Summary : 70-chapter authoritative reference that covers therapeutic monoclonal antibody discovery, development, and clinical applications while incorporating principles, experimental data, and methodologies. First book to address the discovery and development of antibody therapeutics in their entirety. Most chapters contain experimental data to illustrate the principles described in them. Authors provide detailed methodologies that readers can take away with them and use in their own laboratories.

Current Trends in Monoclonal Antibody Development and Manufacturing

Current Trends in Monoclonal Antibody Development and Manufacturing
  • Author : Steven J. Shire,Wayne Gombotz,Karoline Bechtold-Peters,James Andya
  • Publisher :Unknown
  • Release Date :2009-11-11
  • Total pages :354
  • ISBN : 038776643X
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Summary : Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies

Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies
  • Author : Manmohan Singh,Maya Salnikova
  • Publisher :Unknown
  • Release Date :2014-12-30
  • Total pages :520
  • ISBN : 9780124166615
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Summary : Novel Approaches and Strategies for Biologics, Vaccines and Cancer Therapies takes a look at the current strategies, successes and challenges involved with the development of novel formulations of biologics, vaccines and cancer therapy. This thorough reference on the latest trends in the development of diverse modalities will appeal to a broad community of scientists, students and clinicians. Written by leading authors across academia and industry, this book covers important topics such as unique drug delivery devices, non-parenteral delivery trends, novel approaches to the treatment of cancer, immunotherapy and more. It includes real-world cases and examples which highlight formulations with therapeutic proteins, monoclonal antibodies, peptides and biobetters, as well as cases on novel vaccines formulations including evolving pathogens, novel modalities of vaccines, universal vaccines. This book is a thorough and useful resource on the development of novel biologics, vaccines and cancer therapies. Provides strategies for the development of safe and efficacious novel formulations for various modalities of biologics, vaccines and for cancer therapy Highlights novel cases from current clinical trials as well as marketed products Reviews overall successes and challenges in the development of novel formulations, including new molecular targets for the treatment of diseases, design of target-specific therapies, regulatory considerations, individualized therapies

Formulation, Characterization, and Stability of Protein Drugs

Formulation, Characterization, and Stability of Protein Drugs
  • Author : Rodney Pearlman,Y. John Wang
  • Publisher :Unknown
  • Release Date :1996-10-31
  • Total pages :432
  • ISBN : 0306453320
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Summary : Leading scientists offer detailed profiles of ten protein drugs currently in development. The case histories of these important new compounds are described from the perspective of their formulation, characterization, and stability. This ready reference also features recent data and an abundance of previously unpublished information. The in-depth coverage includes a highly useful compendium of degradation sites occurring in over 70 proteins. An invaluable aid in the rapid identification of potential `hot spots' in proteins, this accessible compilation allows for inspection of the protein's primary structure and preparation of a hydroflex plot.

Formulation and Delivery of Proteins and Peptides

Formulation and Delivery of Proteins and Peptides
  • Author : Jeffrey L. Cleland,Robert S. Langer
  • Publisher :Unknown
  • Release Date :1994
  • Total pages :364
  • ISBN : UOM:39015032964028
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Summary : Developed from a symposium sponsored by the Division of Biochemical Technology at the 205th National Meeting of the American Chemical Society, Denver, Colorado, March 28-April 2, 1993.

Challenges in Protein Product Development

Challenges in Protein Product Development
  • Author : Nicholas W. Warne,Hanns-Christian Mahler
  • Publisher :Unknown
  • Release Date :2018-07-22
  • Total pages :599
  • ISBN : 9783319906034
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Summary : 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
  • Author : Christian Klein
  • Publisher :Unknown
  • Release Date :2018-04-27
  • Total pages :238
  • ISBN : 9783038428756
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Summary : This book is a printed edition of the Special Issue "Monoclonal Antibodies" that was published in Antibodies

Biomedical Index to PHS-supported Research

Biomedical Index to PHS-supported Research
  • Author : Anonim
  • Publisher :Unknown
  • Release Date :1990
  • Total pages :229
  • ISBN : IND:30000090515440
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Summary :

Current Trends in Monoclonal Antibody Development and Manufacturing

Current Trends in Monoclonal Antibody Development and Manufacturing
  • Author : Steven J. Shire,Wayne Gombotz,Karoline Bechtold-Peters,James Andya
  • Publisher :Unknown
  • Release Date :2009-11-11
  • Total pages :354
  • ISBN : 038776643X
GET BOOK HERE

Summary : Monoclonal antibodies represent one of the fastest growing areas of new drug development within the pharmaceutical industry. Several blockbuster products have been approved over the past several years including Rituxan, Remicade, Avastin, Humira, and Herceptin. In addition, over 300 new drugs are currently in clinical trials. With both large, established biotechnology companies and small start-ups involved in the development of this important class of molecules, monoclonal antibodies products will become increasingly prevalent over the next decade. Recently the regulatory review of monoclonal antibodies has been moved from Center for Biologics and Research to the Center for Drug Evaluation and Research (CDER) division of the US Food and Drug Administration. It is anticipated that CDER will expect a certain minimal amount of data to be provided as more of these products move through the regulatory pipeline. Current Trends in Monoclonal Antibody Development and Manufacturing will provide readers with an understanding of what is currently being done in the industry to develop, manufacture, and release monoclonal antibody products and what will be required for a successful regulatory submission.

Antibody-Drug Conjugates

Antibody-Drug Conjugates
  • Author : Kenneth J. Olivier, Jr.,Sara A. Hurvitz
  • Publisher :Unknown
  • Release Date :2016-11-14
  • Total pages :560
  • ISBN : 9781119060802
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Summary : Providing practical and proven solutions for antibody-drug conjugate (ADC) drug discovery success in oncology, this book helps readers improve the drug safety and therapeutic efficacy of ADCs to kill targeted tumor cells. • Discusses the basics, drug delivery strategies, pharmacology and toxicology, and regulatory approval strategies • Covers the conduct and design of oncology clinical trials and the use of ADCs for tumor imaging • Includes case studies of ADCs in oncology drug development • Features contributions from highly-regarded experts on the frontlines of ADC research and development

Fermentation Processes

Fermentation Processes
  • Author : Angela Jozala
  • Publisher :Unknown
  • Release Date :2017-02-08
  • Total pages :312
  • ISBN : 9789535129271
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Summary : Fermentation is a theme widely useful for food, feed and biofuel production. Indeed each of these areas, food industry, animal nutrition and energy production, has considerable presence in the global market. Fermentation process also has relevant applications on medical and pharmaceutical areas, such as antibiotics production. The present book, Fermentation Processes, reflects that wide value of fermentation in related areas. It holds a total of 14 chapters over diverse areas of fermentation research.

Therapeutic Fc-Fusion Proteins

Therapeutic Fc-Fusion Proteins
  • Author : Steven M. Chamow,Thomas Ryll,Henry B. Lowman,Deborah Farson
  • Publisher :Unknown
  • Release Date :2013-12-18
  • Total pages :400
  • ISBN : 9783527675289
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Summary : Edited by three pioneers in the field, each with longstanding experience in the biotech industry, and a skilled scientific writer, this is the first book to cover every step in the development and production of immunoglobulin Fc-fusion proteins as therapeutics for human disease: from choosing the right molecular design, to pre-clinical characterization of the purified product, through to batch optimization and quality control for large-scale cGMP production. The whole of the second part is devoted to case studies of Fc-fusion proteins that are now commercially successful products. In this section, the authors, several of whom were personally involved in clinical development of the products themselves, detail the product?s background and give insight into issues that were faced and how these issues were overcome during clinical development. This section also includes a chapter on promising new developments for the future. An invaluable resource for professionals already working on Fc-fusion proteins and an excellent and thorough introduction for physicians, researchers, and students entering the field.

Antibody Methods and Protocols

Antibody Methods and Protocols
  • Author : Gabriele Proetzel,Hilmar Ebersbach
  • Publisher :Unknown
  • Release Date :2012-06-24
  • Total pages :325
  • ISBN : 1617799300
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Summary : The rapidly growing field of antibody research is the result of many advancing technologies allowing current developments to take advantage of molecular engineering to create tailor-made antibodies. Antibody Methods and Protocols attempts to provide insight into the generation of antibodies using in vitro and in vivo approaches, as well as technical aspects for screening, analysis, and modification of antibodies and antibody fragments. The detailed volume is focused on basic protocols for isolating antibodies and, at the same time, it selects a range of specific areas with the aim of providing guides for the overall process of antibody isolation and characterization as well as protocols for enhancing classical antibodies and antibody fragments. Written in the highly successful Methods in Molecular BiologyTM series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible laboratory protocols, and tips on troubleshooting and avoiding known pitfalls. Authoritative and easy to use, Antibody Methods and Protocols provides a broad and useful background to support ongoing efforts by novices and experts alike and encourages the development of new imaginative approaches to this vital area of study.

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals

Formulation and Process Development Strategies for Manufacturing Biopharmaceuticals
  • Author : Feroz Jameel,Susan Hershenson
  • Publisher :Unknown
  • Release Date :2010-07-13
  • Total pages :976
  • ISBN : 9780470595879
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Summary : 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.

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals

The Challenge of CMC Regulatory Compliance for Biopharmaceuticals
  • Author : John Geigert
  • Publisher :Unknown
  • Release Date :2012-12-06
  • Total pages :350
  • ISBN : 9781441991317
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Summary : "The greater our knowledge increases, the more our ignorance unfolds. " U. S. President John F. Kennedy, speech, Rice University, September 12, 1962 My primary purpose for writing this book was much more than to provide another information source on Chemistry, Manufacturing & Controls (CMC) that would rapidly become out of date. My primary purpose was to provide insight and practical suggestions into a common sense business approach to manage the CMC regulatory compliance requirements for biopharmaceuticals. Such a common sense business approach would need (1) to be applicable for all types of biopharmaceutical products both present and future, (2) to address the needs of a biopharmaceutical manufacturer from the beginning to the end of the clinical development stages and including post market approval, and (3) to be adaptable to the constantly changing CMC regulatory compliance requirements and guidance. Trying to accomplish this task was a humbling experience for this author! In Chapter 1, the CMC regulatory process is explained, the breadth of products included under the umbrella ofbiopharmaceuticals are identified, and the track record for the pharmaceutical and biopharmaceutical industry in meeting CMC regulatory compliance is discussed. In Chapter 2, while there are many CMC commonalities between biopharmaceuticals and chemically-synthesized pharmaceuticals, the significant differences in the way the regulatory agencies handle them are examined and the reasons for why such differences are necessary is discussed. Also, the importance of CMC FDA is stressed.

Peptide and Protein Delivery

Peptide and Protein Delivery
  • Author : Chris Van Der Walle
  • Publisher :Unknown
  • Release Date :2011-05-12
  • Total pages :380
  • ISBN : 0123849365
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Summary : 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 biology, immunology, chemistry and biotechnology fields will find this publication invaluable for peptide and protein laboratory research. Discusses the most recent data, ideas and concepts Presents case studies and an industrial perspective Details information from the molecular level to bioprocessing Thought provoking, for the novice to the specialist Timely, for today's biopharmaceuticals market

Biosimilars of Monoclonal Antibodies

Biosimilars of Monoclonal Antibodies
  • Author : Cheng Liu,K. John Morrow, Jr.
  • Publisher :Unknown
  • Release Date :2016-12-12
  • Total pages :704
  • ISBN : 9781118940631
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Summary : Addressing a significant need by describing the science and process involved to develop biosimilars of monoclonal antibody (mAb) drugs, this book covers all aspects of biosimilar development: preclinical, clinical, regulatory, manufacturing. • Guides readers through the complex landscape involved with developing biosimilar versions of monoclonal antibody (mAb) drugs • Features flow charts, tables, and figures that clearly illustrate processes and makes the book comprehensible and accessible • Includes a review of FDA-approved mAb drugs as a quick reference to facts and useful information • Examines new technologies and strategies for improving biosimilar mAbs

Antibody-Drug Conjugates

Antibody-Drug Conjugates
  • Author : Jeffrey Wang,Wei-Chiang Shen,Jennica L. Zaro
  • Publisher :Unknown
  • Release Date :2015-03-05
  • Total pages :252
  • ISBN : 9783319130811
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Summary : This authoritative volume provides a holistic picture of antibody-drug conjugates (ADCs). Fourteen comprehensive chapters are divided into six sections including an introduction to ADCs, the ADC construct, development issues, landscape, IP and pharmacoeconomics, case studies, and the future of the field. The book examines everything from the selection of the antibody, the drug, and the linker to a discussion of developmental issues such as formulations, bio-analysis, pharmacokinetic-pharmacodynamic relationships, and toxicological and regulatory challenges. It also explores pharmacoecomonics and intellectual properties, including recently issued patents and the cost analysis of drug therapy. Case studies are presented for the three ADCs that have received FDA approval: gemtuzumab ozogamicin (Mylotarg®), Brentuximab vedotin (Adcetris®), and ado-trastuzumab emtansine (Kadcyla®), as well as an ADC in late-stage clinical trials, glembatumumab vedotin (CDX-011). Finally, the volume presents a perspective by the editors on the future directions of ADC development and clinical applications. Antibody-Drug Conjugates is a practical and systematic resource for scientists, professors, and students interested in expanding their knowledge of cutting-edge research in this exciting field.