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| benlysta fda approval history: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert, 2014-07-08 This book highlights the challenges facing quality assurance/quality control (QA/QC) in today's biopharmaceutical environment and presents the strategic importance and value generated by QA/QC for their involvement in control of manufacturing. It will put into perspective the need for a graded approach to QA/QC from early clinical trials through market approval. Since the first edition published in 2004, there have been more than 50 new regulatory guidances released by the Food and Drug Administration (FDA), European Medicines Agency (EMA) and ICH that affect the CMC regulatory compliance of biopharmaceuticals; also the application of biosimilars has been developed in Europe and is under development in the USA. The revised update will be broadened to include not only biopharmaceuticals (biotech drugs) but also other biologics (vaccines, cell therapy, plasma-derived proteins, etc.) |
| benlysta fda approval history: The Lupus Encyclopedia Donald E. Thomas Jr., 2023-09-05 Now completely updated! The best-selling, most comprehensive guide to lupus, its complications, and management. Lupus is an autoimmune disease that can attack any body organ. It is three times more common in the United States today than it was in the 1980s, so there is an increased need for accurate, practical information on this potentially devastating disease. Lupus expert and clinician Donald E. Thomas, Jr., MD, provides all the helpful information patients need so they can understand and treat this disease. Highlighting amazing advancements in the diagnosis and treatment of lupus, this edition includes new and expanded information on: • The latest FDA-approved medications • How lupus affects different body parts • Advanced labs that improve lupus diagnosis and treatment • The role of the microbiome and anti-inflammatory diets • Updated recommendations for those who are pregnant or breastfeeding • Childhood-onset lupus • The interaction between COVID-19 and lupus • Non-drug treatments, complementary medicine, and medical cannabis The gold standard since it was first published and carefully reviewed by experts in the field, the latest edition of The Lupus Encyclopedia is essential for patients, health care providers, and families. Bonus content on insurance issues and information about working with lupus and disability is also available online. Endorsed by The Lupus Foundation of America Contributors: Jemima Albayda, MD; Divya Angra, MD; Alan N. Baer, MD; Sasha Bernatsky, MD, PhD; George Bertsias, MD, PhD; Ashira D. Blazer, MD; Ian Bruce, MD; Jill Buyon, MD; Yashaar Chaichian, MD; Maria Chou, MD; Sharon Christie, Esq; Angelique N. Collamer, MD; Ashté Collins, MD; Caitlin O. Cruz, MD; Mark M. Cruz, MD; Dana DiRenzo, MD; Jess D. Edison, MD; Titilola Falasinnu, PhD; Andrea Fava, MD; Cheri Frey, MD; Neda F. Gould, PhD; Nishant Gupta, MD; Sarthak Gupta, MD; Sarfaraz Hasni, MD; David Hunt, MD; Mariana J. Kaplan, MD; Alfred Kim, MD; Deborah Lyu Kim, DO; Rukmini Konatalapalli, MD; Fotios Koumpouras, MD; Vasileios C. Kyttaris, MD; Jerik Leung, MPH; Hector A. Medina, MD; Timothy Niewold, MD; Julie Nusbaum, MD; Ginette Okoye, MD; Sarah L. Patterson, MD; Ziv Paz, MD; Darryn Potosky, MD; Rachel C. Robbins, MD; Neha S. Shah, MD; Matthew A. Sherman, MD; Yevgeniy Sheyn, MD; Julia F. Simard, ScD; Jonathan Solomon, MD; Rodger Stitt, MD; George Stojan, MD; Sangeeta Sule, MD; Barbara Taylor, CPPM, CRHC; George Tsokos, MD; Ian Ward, MD; Emma Weeding, MD; Arthur Weinstein, MD; Sean A. Whelton, MD |
| benlysta fda approval history: The Lupus Book Daniel J. Wallace, 2013 Lupus, a disease of the immune system, can be quite deadly, claiming the lives of thousands of patients yearly. Dr. Daniel J. Wallace is one of the world's leading authorities on this disorder, an eminent clinician who has treated over 3000 lupus patients, the largest such practice in America. His The Lupus Book, originally published in 1995, immediately established itself as the most readable and helpful book on the disease. Now Dr. Wallace has once again completely revised The Lupus Book, incorporating a wealth of new information. This Fifth Edition discusses new drug information and newly discovered information about the pathology of the disease--all laid out in user-friendly language that any patient could understand. In particular, Wallace discusses the first drug for Lupus to be approved by the FDA--belimumab (Benlysta)--as well as other drugs in clinical trials. Readers will also discover fully updated sections on the science of lupus and breakthroughs in research. And as in past editions, the book provides absolutely lucid answers to such questions as: What causes lupus? How and where is the body affected? Can a woman with lupus have a baby? And how can one manage this disease? Indeed, Dr. Wallace has distilled his extensive experience, providing the most up-to-date information on causes, prevention, cure, exercise, diet, and many other important topics. There is also a glossary of terms and an appendix of lupus resource materials compiled by the Lupus Foundation of America. Over a million Americans have lupus. The new Fifth Edition offers these patients and their families an abundance of reliable, up-to-date information that will help them manage the disease and live a happier life. |
| benlysta fda approval history: Guide for Aviation Medical Examiners , 1992 |
| benlysta fda approval history: The Lupus Encyclopedia Donald E. Thomas Jr., 2014-06-23 Systemic lupus erythematosus is an autoimmune disease that can affect any system and organ in the body. This compendium provides detailed explanations of every body system potentially affected by the disease, along with practical advice about coping. |
| benlysta fda approval history: Immunologic Concepts in Transfusion Medicine Robert W Maitta, 2019-08-27 Immunological Concepts in Transfusion Medicine provides a thorough discussion of the immune aspects of blood component transfusion, with in-depth information on the intricacies of immune responses to blood components and the immune processes that may be initiated in response to blood exposure. Written to increase knowledge and awareness of immune challenges such as alloimmunization and transfusion-related acute lung injury, this title bridges current basic scientific discoveries and the potential effects seen in blood recipients. - Complies the knowledge and expertise of Dr. Robert Maitta, an expert in immune responses and antibody function/structure studies. - Helps clinicians in the daily practice of caring for patients in need of transfusion support, as well as physicians in training when considering utilizing blood transfusions in a limited scope or in the setting of massive transfusion. - Includes an immunology primer as an introduction to in-depth chapters covering allergic immune reactions to blood components, transfusion-related immunomodulation, fetal and neonatal alloimmune thrombocytopenia and neonatal neuthropenia, complications of haploidentical and mismatched HSC transplantation, chimeric antibody receptor therapies, and much more. - Consolidates today's available information on this timely topic into a single, convenient resource. |
| benlysta fda approval history: Comprehensive Toxicology , 2017-12-01 Comprehensive Toxicology, Third Edition, Fifteen Volume Set discusses chemical effects on biological systems, with a focus on understanding the mechanisms by which chemicals induce adverse health effects. Organized by organ system, this comprehensive reference work addresses the toxicological effects of chemicals on the immune system, the hematopoietic system, cardiovascular system, respiratory system, hepatic toxicology, renal toxicology, gastrointestinal toxicology, reproductive and endocrine toxicology, neuro and behavioral toxicology, developmental toxicology and carcinogenesis, also including critical sections that cover the general principles of toxicology, cellular and molecular toxicology, biotransformation and toxicology testing and evaluation. Each section is examined in state-of-the-art chapters written by domain experts, providing key information to support the investigations of researchers across the medical, veterinary, food, environment and chemical research industries, and national and international regulatory agencies. Thoroughly revised and expanded to 15 volumes that include the latest advances in research, and uniquely organized by organ system for ease of reference and diagnosis, this new edition is an essential reference for researchers of toxicology. Organized to cover both the fundamental principles of toxicology and unique aspects of major organ systems Thoroughly revised to include the latest advances in the toxicological effects of chemicals on the immune system Features additional coverage throughout and a new volume on toxicology of the hematopoietic system Presents in-depth, comprehensive coverage from an international author base of domain experts |
| benlysta fda approval history: Biosimilarity Sarfaraz K. Niazi, 2018-10-03 Summary: The focus of this book is on how the U.S. FDA will approve biosimilar drugs, as learned from recent approvals by the FDA. Understanding the limitations of the statutory limits and non-inferiority testing are presented as tools to obviate patient trials and minimize testing of immunogenicity. An in-depth scientific, mathematical and statistical view of the tools required to establish biosimilarity of biological drugs of different complexity -- a must for every developer of biosimilars. Features: First comprehensive analysis based on new guidelines and approval packages of several biosimilars Presents the first approach to challenge FDA in reducing or eliminating any testing in patients. Provides a comprehensive understanding of the U.S. statutory requirements vis-a-vis the regulatory guidelines Provides model CQA and Analytical Similarity testing protocols for cytokines and monoclonal antibodies Allow creation of a fast-to-market pathway to develop biosimilars |
| benlysta fda approval history: Pharmacology of Immunotherapeutic Drugs Clinton B. Mathias, Jeremy P. McAleer, Doreen E. Szollosi, 2019-10-18 Medicine has entered a golden age in which therapeutic agents are becoming widely available due to advances in basic science and technology. As such, many drugs have been developed that target inflammatory processes and/or the immune system. This book is intended for health professionals examining the modulation of inflammation by immunotherapeutic drugs. The immune system fills the primordial role of host defense and resistance to infections with pathogenic microorganisms. Several hematopoietic-derived cells constituting the innate and adaptive immune systems cooperate to provide barriers for microbial colonization and/or promote pathogen destruction within the host. Conversely, many immune cells are also involved in the pathogenesis and propagation of chronic inflammatory diseases. The beginning of this book details various components of the immune system including the cell types, lymphoid tissues, soluble cytokines and surface molecules that are essential for host defense. Breakdowns in immune tolerance, or dysregulated immune responses to antigens derived from self tissues or innocuous sources, can lead to the development of autoimmunity or chronic inflammatory diseases. Pathophysiologic roles for the immune system are detailed in corresponding chapters on autoimmunity, epithelial surfaces (lungs, skin, intestine), and transplantation, with special emphasis placed on immunotherapeutic drug targets. The last section of the book focuses on treatments that stimulate our immune system to specifically target and fight infectious diseases and cancer. In each chapter, the medications used to treat various diseases/conditions in terms of their mechanism of action and other pharmacologic properties are detailed. Chapters begin with a table showing drug names and classifications. The importance of basic science and clinical trials cannot be understated in the context of drug development. As such, the discovery of certain medications that had a lasting impact in medicine and pharmacy are highlighted in chapter subsections named “Bench to Bedside.” Several clinical applications of immunotherapeutic drugs are described within end-of -chapter case studies including practice questions. The Pharmacology of Immunotherapeutic Drugs is a reference for immunologists and clinicians (medical doctors, pharmacists, nurses) examining the modulation of inflammatory processes by a variety of medications targeting the cells and mediators of our immune system. |
| benlysta fda approval history: Lehne's Pharmacology for Nursing Care E-Book Jacqueline Burchum, Laura Rosenthal, 2018-03-27 With a clear explanation of drug prototypes and how they work, Lehne's Pharmacology for Nursing Care, 10th Edition gives you the background you need to understand drugs currently on the market, and those not yet released. This perennial favorite of students and teachers simplifies complex concepts while distinguishing need-to-know content from the material that’s merely nice to know. The 10th edition includes updated drug content to reflect the very latest FDA approvals, withdrawals, and therapeutic uses, as well as corresponding updated nursing content. It also includes an updated prototype drugs section, summarizing their major uses, and an updated table detailing care throughout the lifespan of the patient. Additionally, each chapter ends with a nursing implications summary to help you fully understand the material and apply it to clinical nursing practice. Prototype Drugs features serve as a quick-reference learning aid so you can apply your understanding to related drugs currently on the market as well as drugs that will be released in the future. UNIQUE! Engaging writing style with clear explanations makes difficult pharmacology concepts easy to grasp and even enjoyable to learn. Nursing implications of drug therapy are integrated throughout the text to reinforce the integral relationship between drug therapy and nursing care. UPDATED Special Interest Topic boxes focus on currently trending issues in pharmacology, eliminating out-of-date content. Large print highlights essential, need-to-know information, and small print indicates nice-to-know information. QSEN focus includes Patient-Centered Care Across the Life Span features highlighting safe and appropriate patient care during different phases of life. Safety Alert features emphasize the QSEN competency relating to patient safety. Student-friendly features make learning easier with concise drug summary tables, chapter outlines, key points, and a visual guide to the prototype drugs in each class. Concise drug summary tables present detailed information for individual drugs, including drug class, generic and trade names, dosages, routes, and indications. Selected Canadian drug names are indicated with a maple-leaf icon throughout the text. Separate Bioterrorism chapter discusses the clinical manifestations and treatment of biological weapon attacks. NEW! Thoroughly updated drug content reflects the very latest FDA drug approvals, withdrawals, and therapeutic uses, as well as corresponding updated nursing content NEW! Additional images included to accompany difficult concepts. NEW! Inclusion of more student practice questions provide additional help for learning the material. |
| benlysta fda approval history: Immunopharmacology Manzoor M. Khan, 2008-12-19 During the past decades, with the introduction of the recombinant DNA, hybridoma and transgenic technologies there has been an exponential evolution in understanding the pathogenesis, diagnosis and treatment of a large number of human diseases. The technologies are evident with the development of cytokines and monoclonal antibodies as therapeutic agents and the techniques used in gene therapy. Immunopharmacology is that area of biomedical sciences where immunology, pharmacology and pathology overlap. It concerns the pharmacological approach to the immune response in physiological as well as pathological events. This goals and objectives of this textbook are to emphasize the developments in immunology and pharmacology as they relate to the modulation of immune response. The information includes the pharmacology of cytokines, monoclonal antibodies, mechanism of action of immune-suppressive agents and their relevance in tissue transplantation, therapeutic strategies for the treatment of AIDS and the techniques employed in gene therapy. The book is intended for health care professional students and graduate students in pharmacology and immunology. |
| benlysta fda approval history: The Challenge of CMC Regulatory Compliance for Biopharmaceuticals John Geigert, 2019-05-08 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. |
| benlysta fda approval history: Safety of Biologics Therapy Brian A. Baldo, 2016-08-12 This long overdue title provides a comprehensive, up-to-date, state-of-the art review of approved biologic therapies, with coverage of mechanisms of action, Indications for therapy, immunogenicity and a detailed examination of adverse effects and safety of the many and diverse therapeutic agents presented in a total of 13 chapters. It is predicted that by 2016, biologics will make up half of the world's 20 top-selling drugs and by 2018, biologic medicine sales will account for almost half of the world's 100 biggest selling drugs. Recombinant proteins dominate the growing list of the more than 200 approved biotherapeutic agents with targeted antibodies, fusion proteins and receptors; cytokines; hormones; enzymes; proteins involved in blood-clotting, homeostasis and thrombosis; vaccines; botulinum neurotoxins; and, more recently, biosimilar preparations, comprising the majority of approved biologics. Written with clinicians, other health care professionals, and researchers in mind, Safety of Biologics Therapy examines, in a single volume, the full range of issues surrounding the safety of approved biologic therapies. A good understanding of the risks and safety issues of modern biologics therapy is increasingly being demanded of all those connected with their development, handling, prescribing, administration and subsequent patient management. In addition to being of great value to clinicians in all branches of medicine, and to nurses, pharmacists and researchers, this book will prove invaluable for students taking undergraduate and graduate courses in the above disciplines and in the biomedical sciences. |
| benlysta fda approval history: MoneyBall Medicine Harry Glorikian, Malorye Allison Branca, 2017-11-20 How can a smartwatch help patients with diabetes manage their disease? Why can’t patients find out prices for surgeries and other procedures before they happen? How can researchers speed up the decade-long process of drug development? How will Precision Medicine impact patient care outside of cancer? What can doctors, hospitals, and health systems do to ensure they are maximizing high-value care? How can healthcare entrepreneurs find success in this data-driven market? A revolution is transforming the $10 trillion healthcare landscape, promising greater transparency, improved efficiency, and new ways of delivering care. This new landscape presents tremendous opportunity for those who are ready to embrace the data-driven reality. Having the right data and knowing how to use it will be the key to success in the healthcare market in the future. We are already starting to see the impacts in drug development, precision medicine, and how patients with rare diseases are diagnosed and treated. Startups are launched every week to fill an unmet need and address the current problems in the healthcare system. Digital devices and artificial intelligence are helping doctors do their jobs faster and with more accuracy. MoneyBall Medicine: Thriving in the New Data-Driven Healthcare Market, which includes interviews with dozens of healthcare leaders, describes the business challenges and opportunities arising for those working in one of the most vibrant sectors of the world’s economy. Doctors, hospital administrators, health information technology directors, and entrepreneurs need to adapt to the changes effecting healthcare today in order to succeed in the new, cost-conscious and value-based environment of the future. The authors map out many of the changes taking place, describe how they are impacting everyone from patients to researchers to insurers, and outline some predictions for the healthcare industry in the years to come. |
| benlysta fda approval history: Immunotherapy – A Novel Facet of Modern Therapeutics Sujata P. Sawarkar, Vandana S. Nikam, Shariq Syed, 2020-12-16 This book illustrates the significance and relevance of immunotherapy in modern-day therapeutics. Focusing on the application of immunotherapy in oncology, neurodegenerative and autoimmune diseases, it discusses the drug delivery systems, and pre-clinical and clinical methodologies for immunotherapy-based drugs. It also comprehensively reviews various aspects of immunotherapy, such as regulatory affairs, quality control, safety, and pharmacovigilance. Further, the book discusses the in vitro validation of therapeutic strategies prior to patient application and management of immunotherapy-related side effects and presents case studies demonstrating the design and development (pre-clinical to clinical) of immunotherapy for various diseases. It also describes various design considerations and the scale-up synthesis of immunotherapeutics and screening methods. Lastly, it explores the important aspect of cost-effectiveness and rational immunotherapy strategies. |
| benlysta fda approval history: Therapeutic Antibody Engineering William R Strohl, Lila M Strohl, 2012-10-16 The field of antibody engineering has become a vital and integral part of making new, improved next generation therapeutic monoclonal antibodies, of which there are currently more than 300 in clinical trials across several therapeutic areas. Therapeutic antibody engineering examines all aspects of engineering monoclonal antibodies and analyses the effect that various genetic engineering approaches will have on future candidates. Chapters in the first part of the book provide an introduction to monoclonal antibodies, their discovery and development and the fundamental technologies used in their production. Following chapters cover a number of specific issues relating to different aspects of antibody engineering, including variable chain engineering, targets and mechanisms of action, classes of antibody and the use of antibody fragments, among many other topics. The last part of the book examines development issues, the interaction of human IgGs with non-human systems, and cell line development, before a conclusion looking at future issues affecting the field of therapeutic antibody engineering. - Goes beyond the standard engineering issues covered by most books and delves into structure-function relationships - Integration of knowledge across all areas of antibody engineering, development, and marketing - Discusses how current and future genetic engineering of cell lines will pave the way for much higher productivity |
| benlysta fda approval history: Monoclonal Antibody Production National Research Council, Institute for Laboratory Animal Research, Committee on Methods of Producing Monoclonal Antibodies, 1999-05-06 The American Anti-Vivisection Society (AAVS) petitioned the National Institutes of Health (NIH) on April 23, 1997, to prohibit the use of animals in the production of mAb. On September 18, 1997, NIH declined to prohibit the use of mice in mAb production, stating that the ascites method of mAb production is scientifically appropriate for some research projects and cannot be replaced. On March 26, 1998, AAVS submitted a second petition, stating that NIH failed to provide valid scientific reasons for not supporting a proposed ban. The office of the NIH director asked the National Research Council to conduct a study of methods of producing mAb. In response to that request, the Research Council appointed the Committee on Methods of Producing Monoclonal Antibodies, to act on behalf of the Institute for Laboratory Animal Research of the Commission on Life Sciences, to conduct the study. The 11 expert members of the committee had extensive experience in biomedical research, laboratory animal medicine, animal welfare, pain research, and patient advocacy (Appendix B). The committee was asked to determine whether there was a scientific necessity for the mouse ascites method; if so, whether the method caused pain or distress; and, if so, what could be done to minimize the pain or distress. The committee was also asked to comment on available in vitro methods; to suggest what acceptable scientific rationale, if any, there was for using the mouse ascites method; and to identify regulatory requirements for the continued use of the mouse ascites method. The committee held an open data-gathering meeting during which its members summarized data bearing on those questions. A 1-day workshop (Appendix A) was attended by 34 participants, 14 of whom made formal presentations. A second meeting was held to finalize the report. The present report was written on the basis of information in the literature and information presented at the meeting and the workshop. |
| benlysta fda approval history: Bioelectronic Medicine Valentin A. Pavlov, 2019 Cold Spring Harbor perspectives in medicine. |
| benlysta fda approval history: Therapeutic Fc-Fusion Proteins Steven M. Chamow, Thomas Ryll, Henry B. Lowman, Deborah Farson, 2013-12-18 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. |
| benlysta fda approval history: Lyophilized Biologics and Vaccines Dushyant Varshney, Manmohan Singh, 2015-05-19 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. |
| benlysta fda approval history: Antibody Glycosylation Marija Pezer, 2021-10-22 This book summarizes recent advances in antibody glycosylation research. Covering major topics relevant for immunoglobulin glycosylation - analytical methods, biosynthesis and regulation, modulation of effector functions - it provides new perspectives for research and development in the field of therapeutic antibodies, biomarkers, vaccinations, and immunotherapy. Glycans attached to both variable and constant regions of antibodies are known to affect the antibody conformation, stability, and effector functions. Although it focuses on immunoglobulin G (IgG), the most explored antibody in this context, and unravels the natural phenomena resulting from the mixture of IgG glycovariants present in the human body, the book also discusses other classes of human immunoglobulins, as well as immunoglobulins produced in other species and production systems. Further, it reviews the glycoanalytical methods applied to antibodies and addresses a range of less commonly explored topics, such as automatization and bioinformatics aspects of high-throughput antibody glycosylation analysis. Lastly, the book highlights application areas ranging from the ones already benefitting from antibody glycoengineering (such as monoclonal antibody production), to those still in the research stages (such as exploration of antibody glycosylation as a clinical or biological age biomarker), and the potential use of antibody glycosylation in the optimization of vaccine production and immunization protocols. Summarizing the current knowledge on the broad topic of antibody glycosylation and its therapeutic and biomarker potential, this book will appeal to a wide biomedical readership in academia and industry alike. Chapter 4 is available open access under a Creative Commons Attribution 4.0 International License via link.springer.com. |
| benlysta fda approval history: Microbes Prakash S. Bisen, Mousumi Debnath, G. B. Prasad, 2012-06-22 An accessible introduction to the world of microbes—from basic microbe biology through industrial applications Microbes affect our lives in a variety of ways—playing an important role in our health, food, agriculture, and environment. While some microbes are beneficial, others are pathogenic or opportunistic. Microbes: Concepts and Applications describes basic microbe biology and identification and shows not only how they operate in the subfields of medicine, biotechnology, environmental science, bioengineering, agriculture, and food science, but how they can be harnessed as a resource. It provides readers with a solid grasp of etiologic agents, pathogenic processes, epidemiology, and the role of microbes as therapeutic agents. Placing a major emphasis on omics technology, the book covers recent developments in the arena of microbes and discusses their role in industry and agriculture, as well as in related fields such as immunology, cell biology, and molecular biology. It offers complete discussions of the major bacterial, viral, fungal, and parasitic pathogens; includes information on emerging infectious diseases, antibiotic resistance, and bioterrorism; and talks about the future challenges in microbiology. The most complete treatment of microbial biology available, Microbes features eye-opening chapters on: Human and Microbial World Gene Technology: Application and Techniques Molecular Diagnostic and Medical Microbiology Identification and Classification of Microbes Diversity of Microorganisms Microbes in Agriculture Microbes as a Tool for Industry and Research Complete with charts and figures, this book is an invaluable textbook for university teachers, students, researchers, and people everywhere who care about microorganisms. |
| benlysta fda approval history: NanoBioMedicine Shailendra K. Saxena, S. M. Paul Khurana, 2020-02-03 This book provides a comprehensive overview of the recent trends in various Nanotechnology-based therapeutics and challenges associated with its development. Nanobiotechnology is an interdisciplinary research that has wide applications in the various fields of biomedical research. The book discusses the various facets of the application of Nanotechnology in drug delivery, clinical diagnostics, Nanomedicine and treatment of infectious and chronic diseases. The book also highlights the recent advancements on important devices and applications that are based on Nanotechnology in medicine and brief the regulatory and ethical issues related to nanomedical devices. It also reviews the toxicological profile of various nanomaterials and emphasizes the need for safe nanomaterials for clinical use. Finally, the book discusses the recent developments of potential commercial applications of Nanotechnology. |
| benlysta fda approval history: Adverse Reactions to Biologics L. Puig, W. Gulliver, 2017-11-07 In many areas of medicine physicians still face the great challenge of finding therapies that will meet the patients’ needs. In dermatology the challenge has arisen on multiple fronts through advances in the understanding of the immunopathogenesis of many inflammatory and malignant cutaneous disorders. Breakthroughs, combined with significant developments in targeted immunotherapy, have resulted in improved outcomes as these newer therapies are being used for both approved indications and as off-label therapies for various chronic inflammatory skin disorders and many forms of skin cancer. In the expectation that by truly understanding the safety profile of these targeted therapies patients’ outcomes will be significantly improved, this book offers insights into topics such as adverse reactions, infectious complications and the perioperative use of biologics in psoriasis, immunogenicity of biologic therapies, paradoxical reactions, safety of biologics used to treat autoimmune bullous diseases and primary cutaneous lymphomas, adverse reactions and skin manifestations of therapies targeting melanoma and non-melanoma skin cancer and other neoplastic diseases. Eminent researchers with extensive clinical experience have contributed to this publication, providing an in-depth overview of the latest knowledge in this field. |
| benlysta fda approval history: Textbook of Pediatric Rheumatology Ross E. Petty, 2005 Clinical reference designed to aid in the care of children with rheumatic diseases. Offers guidelines for interpreting the signs, symptoms and laboratory abnormalities that accompany these disorders. Includes numerous halftone illustrations and tables, radiographs, and other figures. |
| benlysta fda approval history: Clinical Pharmacy Education, Practice and Research Dixon Thomas, 2018-11-23 Clinical Pharmacy Education, Practice and Research offers readers a solid foundation in clinical pharmacy and related sciences through contributions by 83 leading experts in the field from 25 countries. This book stresses educational approaches that empower pharmacists with patient care and research competencies. The learning objectives and writing style of the book focus on clarifying the concepts comprehensively for a pharmacist, from regular patient counseling to pharmacogenomics practice. It covers all interesting topics a pharmacist should know. This book serves as a basis to standardize and coordinate learning to practice, explaining basics and using self-learning strategies through online resources or other advanced texts. With an educational approach, it guides pharmacy students and pharmacists to learn quickly and apply. Clinical Pharmacy Education, Practice and Research provides an essential foundation for pharmacy students and pharmacists globally. - Covers the core information needed for pharmacy practice courses - Includes multiple case studies and practical situations with 70% focused on practical clinical pharmacology knowledge - Designed for educational settings, but also useful as a refresher for advanced students and researchers |
| benlysta fda approval history: Patient-Reported Outcomes Joseph C. Cappelleri, Kelly H. Zou, Andrew G. Bushmakin, Jose Ma. J. Alvir, Demissie Alemayehu, Tara Symonds, 2013-12-20 Advancing the development, validation, and use of patient-reported outcome (PRO) measures, Patient-Reported Outcomes: Measurement, Implementation and Interpretation helps readers develop and enrich their understanding of PRO methodology, particularly from a quantitative perspective. Designed for biopharmaceutical researchers and others in the health sciences community, it provides an up-to-date volume on conceptual and analytical issues of PRO measures. The book discusses key concepts relating to the measurement, implementation, and interpretation of PRO measures. It covers both introductory and advanced psychometric and biostatistical methods for constructing and analyzing PRO measures. The authors include many relevant real-life applications based on their extensive first-hand experiences in the pharmaceutical industry. They implement a wealth of simulated datasets to illustrate concepts and heighten understanding based on practical scenarios. For readers interested in conducting statistical analyses of PRO measures and delving more deeply into the analytic details, most chapters contain SAS code and output that illustrate the methodology. Along with providing numerous references, the book highlights current regulatory guidelines. |
| benlysta fda approval history: Stiehm's Immune Deficiencies Kathleen E. Sullivan, E. Richard Stiehm, 2020-05-23 Stiehm's Immune Deficiencies: Inborn Errors in Immunity, Second Edition, is ideal for physicians and other caregivers who specialize in immunology, allergies, infectious diseases and pulmonary medicine. It provides a validated source of information for care delivery to patients, covering approaches to diagnosis that use both new genetic information and emphasize screening strategies. Management has changed dramatically over the past five years, so approaches to infection and autoimmunity are emphasized in an effort to improve outcomes and disseminate new information on the uses of targeted therapy. - Covers immune deficiencies that are presented in a practical way, providing helpful information for active clinicians - Fills an increasingly deep gap in the information available to clinicians - Presents both clinical management and scientific advances for immune deficiencies - Provides a primary resource for physicians in the field of immunodeficiencies - Includes website access to a range of videos relevant to the topics discussed |
| benlysta fda approval history: Pharmaceutical Biotechnology Daan J. A. Crommelin, Robert D. Sindelar, 2002-11-14 The field of pharmaceutical biotechnology is evolving rapidly. A whole new arsenal of protein pharmaceuticals is being produced by recombinant techniques for cancer, viral infections, cardiovascular and hereditary disorders, and other diseases. In addition, scientists are confronted with new technologies such as polymerase chain reactions, combinatorial chemistry and gene therapy. This introductory textbook provides extensive coverage of both the basic science and the applications of biotechnology-produced pharmaceuticals, with special emphasis on their clinical use. Pharmaceutical Biotechnology serves as a complete one-stop source for undergraduate pharmacists, and it is valuable for researchers and professionals in the pharmaceutical industry as well. |
| benlysta fda approval history: Outside the Box Cancer Therapies Dr. Mark Stengler, 2019-05-07 Now in paperback: A thorough, cutting-edge, alternative therapy-focused exploration of Integrative Oncology care. With approximately 40 percent of men and women in the United States being diagnosed with cancer at some point in their lifetime, very few of us escape having cancer touch our lives in some way--whether it is our own life or that of a loved one. Scientific research continues to prove the benefits of nutritional and holistic therapies, yet, for the most part, these approaches to treatment still remain unexplored by the conventional medical establishment. With integrative and holistic healing being sought after and supported by more and more of the general public and medical community for various elements of everyday life, it only makes logical sense to explore these therapies with regard to one of the most prevalent causes of death of our time. In Outside the Box Cancer Therapies, naturopathic medical doctors Mark Stengler and Paul Anderson combine their expertise to focus on the most critical components of integrative oncology care. Supported by extensive research and decades of clinical experience, Dr. Stengler and Dr. Anderson thoroughly explain: • the different types of cancer and their causes • how proper nutrition can help to prevent and treat cancer • the most well-studied supplements to use with cancer treatment • cutting-edge naturopathic therapies, and • natural solutions to common problems, such as the side effects of chemotherapy and radiation With a clear and focused approach, Dr. Stengler and Dr. Anderson provide a definitive and comprehensive resource for anyone seeking to heal from cancer or a professional looking for the most cutting, up-to-date integrative approaches to treatment. |
| benlysta fda approval history: Lyophilization of Biopharmaceuticals Henry R. Costantino, Michael J. Pikal, 2005-12-05 Humans have been experimenting with lyophilization, or freeze-drying, as a method to preserve biological structures for over a thousand years. This comprehensive volume, intended for scientists in both academia and industry, covers a wide range of topics relevant to the formulation of peptide and protein drugs in the freeze-dried state. |
| benlysta fda approval history: Biotechnology Entrepreneurship Craig Shimasaki, 2014-04-08 As an authoritative guide to biotechnology enterprise and entrepreneurship, Biotechnology Entrepreneurship and Management supports the international community in training the biotechnology leaders of tomorrow. Outlining fundamental concepts vital to graduate students and practitioners entering the biotech industry in management or in any entrepreneurial capacity, Biotechnology Entrepreneurship and Management provides tested strategies and hard-won lessons from a leading board of educators and practitioners. It provides a 'how-to' for individuals training at any level for the biotech industry, from macro to micro. Coverage ranges from the initial challenge of translating a technology idea into a working business case, through securing angel investment, and in managing all aspects of the result: business valuation, business development, partnering, biological manufacturing, FDA approvals and regulatory requirements. An engaging and user-friendly style is complemented by diverse diagrams, graphics and business flow charts with decision trees to support effective management and decision making. - Provides tested strategies and lessons in an engaging and user-friendly style supplemented by tailored pedagogy, training tips and overview sidebars - Case studies are interspersed throughout each chapter to support key concepts and best practices. - Enhanced by use of numerous detailed graphics, tables and flow charts |
| benlysta fda approval history: Technical Analysis of Gaps Julie R. Dahlquist, Richard J. Bauer, 2012 Gaps have attracted the attention of market technicians from the earliest days of charting. They're not merely conspicuous: they represent price jumps that could signal profitable trading opportunities. Until now, however, folklore about gap trading has been common, and tested, research-based knowledge virtually nonexistent. In Technical Analysis of Gaps, renowned technical analysis researchers Julie Dahlquist and Richard Bauer change all that. Drawing on 60 years of comprehensive data, they demonstrate how to sort strategic gaps from trivial ones, and successfully trade on gaps identified as significant. Building on work that recently earned them the Market Technicians Association's 2011 Charles H. Dow Award for creativity and innovation in technical analysis, Dahlquist and Bauer offer specific gap-related trading tips for stocks, futures, and options. They consider a wide variety of market conditions, including gap size, volume and previous price movement, illuminating their findings with easy-to-understand diagrams. Coverage includes: understanding what gaps are and how they arise; recognizing windows on candlestick charts; identifying gaps with superior profit potential; combining gaps with other technical techniques for a more complete and effective analysis; and putting it all together with real trading strategies. For stock, commodity, and currency traders in the U.S. and worldwide, and for active individual investors seeking new ways to maximize returns. |
| benlysta fda approval history: Lipid Nanocarriers for Drug Targeting Alexandru Mihai Grumezescu, 2018-04-16 Lipid Nanocarriers for Drug Targeting presents recent advances in the area of lipid nanocarriers. The book focuses on cationic lipid nanocarriers, solid lipid nanocarriers, liposomes, thermosensitive vesicles, and cubosomes, with applications in phototherapy, cosmetic and others. As the first book related to lipid nanocarriers and their direct implication in pharmaceutical nanotechnology, this important reference resource is ideal for biomaterials scientists and those working in the medical and pharmaceutical industries that want to learn more on how lipids can be used to create more effective drug delivery systems. - Highlights the most commonly used types of lipid nanocarriers and explains how they are applied in pharmacy - Shows how lipid nanocarriers are used in different types of treatment, including oral medicine, skin repair and cancer treatment - Assesses the pros and cons of using different lipid nanocarriers for different therapies |
| benlysta fda approval history: Ethnic Skin and Hair and Other Cultural Considerations Becky S. Li, Howard I. Maibach, 2021-03-03 This book is written to help educate dermatologists and general physicians of the challenges involved in treating those with darker skin tones in culturally appropriate ways. Distinctly broken up into three sections for ease of use, the reader enters the text through a series of chapters meant to introduce the physician to the anatomical structure and makeup of patient with skin of color as well as the evolution basic concepts for understanding and treatment. The second and longest section looks at diseases and cosmetic concerns covering some of the most common issues for patients with skin of color. The last section offers cultural considerations to treatment and care. Socially conscious and comprehensive, Ethnic Skin and Hair is written by some of the leading names in dermatological treatment of skin of color, and functions as a concise and thorough tool for dermatologists at every stage in their career. |
| benlysta fda approval history: Human Monoclonal Antibodies Michael Steinitz, 2013-09-14 The introduction of monoclonal antibodies revolutionized immunology. The development of human monoclonal antibodies was inspired primarily by the enormous clinical benefits promised by these reagents which can be used as anti-inflammatory reagents, anti-tumor reagents and reagents for passive immunization in a variety of pathologies. Human Monoclonal Antibodies: Methods and Protocols presents technical protocols of cellular and molecular methods for the production, purification and application of human monoclonal antibodies, as well as review articles on related topics of human monoclonal and polyclonal antibodies. Written in the successful Methods in Molecular Biology series format, chapters include introductions to their respective topics, lists of the necessary materials and reagents, step-by-step, readily reproducible protocols, and notes on troubleshooting and avoiding known pitfalls. Authoritative and easily accessible, Human Monoclonal Antibodies: Methods and Protocols seeks to serve both professionals and novices with its well-honed methodologies which will prove invaluable in a clinical setting. |
| benlysta fda approval history: Lahita's Systemic Lupus Erythematosus Robert G. Lahita, 2021-07-27 Systemic lupus erythematosus (SLE), commonly called lupus, is a chronic autoimmune disorder that can affect virtually any organ of the body. In lupus, the body's immune system, which normally functions to protect against foreign invaders, becomes hyperactive, forming antibodies that attack normal tissues and organs, including the skin, joints, kidneys, brain, heart, lungs, and blood. Lupus is characterized by periods of illness, called flares, and periods of wellness or remission. Because its symptoms come and go and mimic those of other diseases, lupus is difficult to diagnose. There is no single laboratory test that can definitively prove that a person has the complex illness. To date, lupus has no known cause or cure. Early detection and treatment are the key to a better health outcome and can usually lessen the progression and severity of the disease. Anti-inflammatory drugs, antimalarials, and steroids (such as cortisone and others) are often used to treat lupus. Cytotoxic chemotherapies, like those used in the treatment of cancer, are also used to suppress the immune system in lupus patients. A new edition of this established and well-regarded reference combines basic science with clinical science to provide a translational medicine model. Systemic Lupus Erythematosus, Sixth Edition, is a useful reference for specialists in the diagnosis and management of patients with SLE, a tool for measurement of clinical activity for pharmaceutical development and basic research of the disease, and a reference work for hospital libraries. Completely updated, revised, and expanded with the most comprehensive and accessible reference on SLE for clinicians and scientists Full-color presentation throughout the book Provides the latest information available on diagnosis and treatment Incorporates an international panel of authors who are experts in their fields, with an emphasis on young, cutting-edge scientists and physicians |
| benlysta fda approval history: Podocytopathy Z.-H. Liui, J.C. He, 2014-05-16 The podocyte is a key cell that forms the last barrier of the kidney filtration unit. One of the most exciting developments in the field of nephrology in the last decade has been the elucidation of its biology and its role in the pathophysiology of inherited and acquired glomerular disease, termed podocytopathy. In this publication, world-renowned experts summarize the most recent findings and advances in the field: they describe the unique biological features and injury mechanisms of the podocyte, novel techniques used in their study, and diagnosis and potential therapeutic approaches to glomerular diseases. Due to its broad scope, this publication is of great value not only for clinical nephrologists and researchers, but also for students, residents, fellows, and postdocs. |
| benlysta fda approval history: Antibody Drug Discovery Clive R. Wood, 2012 Antibody-based therapeutics are a central driver of the success of biopharmaceuticals. The discovery technology of this field is isolated to a limited number of centers of excellence in industry and academia. The objective of this volume is to provide a series of guides to those evaluating and preparing to enter particular areas within the field. Each chapter is written with a historical perspective that sets into context the significance of the key developments, and with the provision of “points to consider” for the reader as a value-added feature of the volume. All contributors are experts in their fields and have played pivotal roles in the creation of the technology. |
| benlysta fda approval history: FDA Approval of New Drugs United States. Food and Drug Administration, 1971 |
Benlysta: Uses, Dosage, Side Effects, Warnings - Drugs.com
Nov 8, 2024 · Benlysta is used to treat active systemic lupus erythematosus (SLE) or active lupus nephritis (lupus-related kidney inflammation) in adults and children 5 years of age and older. …
Belimumab - Wikipedia
Belimumab, sold under the brand name Benlysta, is a human monoclonal antibody that inhibits B-cell activating factor (BAFF), [6] also known as B-lymphocyte stimulator (BLyS). [7] It is …
BENLYSTA (belimumab) for Lupus and Lupus Nephritis | for HCPs
Target lupus with BENLYSTA (belimumab). Learn how BENLYSTA works and reduced disease activity in patients with lupus and lupus nephritis.
Benlysta: What you need to know - Lupus Foundation of America
Benlysta is the FIRST FDA-approved medication specifically designed for the treatment of lupus. Benlysta targets specific immune cells, rather than the blanket approach of other therapies …
Benlysta (belimumab) - Uses, Side Effects, and More
Sep 17, 2024 · Benlysta is a type of medicine called a monoclonal antibody. It blocks a substance in the body, called B lymphocyte stimulator (BLyS), from binding to B cells, which are part of …
BENLYSTA® (belimumab) Label - Food and Drug …
BENLYSTA is a B-lymphocyte stimulator (BLyS)-specific inhibitor indicated for the treatment of adult patients with active, autoantibody-positive, systemic lupus erythematosus who are...
Benlysta: Side effects, uses, cost, dosage, and more - Medical …
Mar 7, 2025 · Benlysta (belimumab) is a prescription drug that treats systemic lupus erythematosus (SLE) and lupus nephritis. Learn about side effects, uses, cost, and more.
Benlysta - European Medicines Agency (EMA)
Jan 20, 2025 · Benlysta is a medicine used as an add-on treatment in patients aged 5 years and older with systemic lupus erythematosus (SLE), a disease in which the immune system (the …
Benlysta (Belimumab): Side Effects, Uses, Dosage, Interactions
May 25, 2024 · Benlysta (belimumab) is a monoclonal antibody indicated for the treatment of adult patients with active systemic lupus erythematosus (SLE). Benlysta has not been evaluated in …
Benlysta Patient Tips: 7 things you should know - Drugs.com
May 21, 2024 · Benlysta (pronounced ben-LIST-ah) is a prescription medicine used with other lupus treatments to treat active systemic lupus erythematosus (SLE) and active lupus nephritis …
Benlysta: Uses, Dosage, Side Effect…
Nov 8, 2024 · Benlysta is used to treat active systemic lupus erythematosus (SLE) or active lupus nephritis …
Belimumab - Wikipedia
Belimumab, sold under the brand name Benlysta, is a human monoclonal antibody that inhibits B-cell …
BENLYSTA (belimumab) for Lup…
Target lupus with BENLYSTA (belimumab). Learn how BENLYSTA works and reduced …
Benlysta: What you need to know - Lup…
Benlysta is the FIRST FDA-approved medication specifically designed for the treatment of lupus. …
Benlysta (belimumab) - Uses, Side Effec…
Sep 17, 2024 · Benlysta is a type of medicine called a monoclonal antibody. It blocks a substance in …
