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Author: John Geigert Publisher: Springer Nature ISBN: 3031319095 Category : Science Languages : en Pages : 597
Book Description
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Author: John Geigert Publisher: Springer Nature ISBN: 3031319095 Category : Science Languages : en Pages : 597
Book Description
Each year for the past three years, there have been about 50 new molecular medicines approved by the United States Food & Drug Administration (FDA), of which approximately 25% were new biopharmaceuticals. Over 200 recombinant proteins, monoclonal antibodies, antibody drug conjugates, fusion proteins, and Fab fragments are now in the marketplace in both the United States of America (USA) and European Union (EU). There are also now over 60 biosimilars available for all major classes of recombinant proteins and monoclonal antibodies. In addition, gene therapies using genetically engineered viruses and genetically engineered cells are now in the marketplace, and continually growing. This degree of change is reflected in the over 400 CMC regulatory compliance references listed in this book that were either issued or updated since the release of the third edition. Deficiencies in biopharmaceutical CMC regulatory compliance rarely result in termination of a product, but in can readily cause months if not years of delay in initiating clinical trials, or advancing clinical development stages, or even market approval. In summary, this book: Updates real-world CMC deficiency examples with current examples; Addresses current FDA and EMA requirements and expectations for CMC regulatory compliance; Now includes CMC regulatory compliance for the new gene-based biopharmaceuticals.
Author: John Geigert Publisher: Springer Science & Business Media ISBN: 1461469163 Category : Medical Languages : en Pages : 362
Book Description
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.)
Author: Feroz Jameel Publisher: Springer Nature ISBN: 3030314154 Category : Medical Languages : en Pages : 888
Book Description
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.
Author: Ralf Pörtner Publisher: Springer Nature ISBN: 3031456696 Category : Science Languages : en Pages : 497
Book Description
This volume “Cell Engineerring 11 - Biopharmaceutical Manufacturing: Progress, Trends and Challenges” is a source of the latest innovative research and technical development in biomanufacturing systems. It is organised into 2 parts: 1) Manufacturing of recombinant therapeutic proteins (e.g. therapeutic antibodies, biosimilars/biogenerics) and 2) Manufacturing aspects of cell and gene therapy. Each with selected chapters on the following topics for both up- and downstream, such as: Advanced process strategies, especially continuous manufacturing, Advanced culture techniques, especially single-use systems, Process transfer, scale-up/scale-down models, Processing advances/Manufacturing productivity/efficiency, Model-assisted process understanding and development/Digital Twins, Process controls and analytics, Quality control, Quality by design, Facility design and full-scale commercial systems, manufacturing technology innovation. The book comprises contributions of experts from academia and industry active in the field of cell culture development for the production of recombinant proteins, cell therapy and gene therapy, with consideration of Digital Twin ́s and facility design. The knowledge and expertise of the authors cover disciplines like cell biology, engineering, biotechnology and biomedical sciences. Inevitably, some omissions will occur in the test, but the authors have sought to avoid duplications by extensive cross-referencing to chapters in other volumes of this series and elsewhere. We hope the volume provides a useful compendium of techniques for scientists in industrial and research laboratories active in this field.
Author: Ved Srivastava Publisher: Royal Society of Chemistry ISBN: 1788014332 Category : Science Languages : en Pages : 572
Book Description
Peptide therapy has become a key strategy in innovative drug development, however, one of the potential barriers for the development of novel peptide drugs in the clinic is their deficiencies in clearly defined chemistry, manufacturing and controls (CMC) strategy from clinical development to commercialization. CMC can often become a rate-limiting step due to lack of knowledge and lack of a formal policy or guidelines on CMC for peptide-based drugs. Regulators use a risk-based approach, reviewing applications on a case-by-case basis. Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls covers efficient manufacturing of peptide drug substances, a review of the process for submitting applications to the regulatory authority for drug approval, a holistic approach for quality attributes and quality control from a regulatory perspective, emerging analytical tools for the characterisation of impurities, and the assessment of stability. This book is an essential reference work for students and researchers, in both academia and industry, with an interest in learning about CMC, and facilitating development and manufacture of peptide-based drugs.
Author: Robert James Cimasi Publisher: John Wiley & Sons ISBN: 1118844033 Category : Business & Economics Languages : en Pages : 1098
Book Description
A timely look at the healthcare valuation process in an era of dynamic healthcare reform, including theory, methodology, and professional standards In light of the dynamic nature of the healthcare industry sector, the analysis supporting business valuation engagements for healthcare enterprises, assets, and services must address the expected economic conditions and events resulting from the four pillars of the healthcare industry: Reimbursement, Regulation, Competition, and Technology. Healthcare Valuation presents specific attributes of each of these enterprises, assets, and services and how research needs and valuation processes differentiate depending on the subject of the appraisal, the environment the property interest exists, and the nature of the practices. Includes theory, methodology, and professional standards as well as requisite research, analytical, and reporting functions in delivering healthcare valuation services Provides useful process tools such as worksheets and checklists, relevant case studies, plus a website that will include comprehensive glossaries and topical bibliographies Read Healthcare Valuation for a comprehensive treatise of valuation issues in the healthcare field including trends of compensation and reimbursement, technology and intellectual property, and newly emerging healthcare entities.
Author: Robert James Cimasi Publisher: John Wiley & Sons ISBN: 1118292790 Category : Business & Economics Languages : en Pages : 752
Book Description
In light of the dynamic nature of the healthcare industry sector, the analysis supporting business valuation engagements for healthcare enterprises, assets, and services must address the expected economic conditions and events resulting from the four pillars of the healthcare industry: reimbursement, regulation, competition, and technology. This title presents specific attributes of each of these enterprises, assets, and services and how research needs and valuation processes differentiate depending on the subject of the appraisal, the environment the property interest exists, and the nature of the practices.
Author: Maria Cristina Galli Publisher: Springer ISBN: 3319186183 Category : Medical Languages : en Pages : 235
Book Description
This book discusses the different regulatory pathways for gene therapy (GT) and cell therapy (CT) medicinal products implemented by national and international bodies throughout the world (e.g. North and South America, Europe, and Asia). Each chapter, authored by experts from various regulatory bodies throughout the international community, walks the reader through the applications of nonclinical research to translational clinical research to licensure for these innovative products. More specifically, each chapter offers insights into fundamental considerations that are essential for developers of CT and GT products, in the areas of product manufacturing, pharmacology and toxicology, and clinical trial design, as well as pertinent "must-know" guidelines and regulations. Regulatory Aspects of Gene Therapy and Cell Therapy Products: A Global Perspective is part of the American Society of Gene and Cell Therapy sub-series of the highly successful Advances in Experimental Medicine and Biology series. It is essential reading for graduate students, clinicians, and researchers interested in gene and cell therapy and the regulation of pharmaceuticals.
Author: Steve L. Nail Publisher: Springer Science & Business Media ISBN: 1461505496 Category : Medical Languages : en Pages : 479
Book Description
In this era of biotechnology there have been many books covering the fundamentals of recombinant DNA technology and protein chemistry. However, not many sources are available for the pharmaceutical develop ment scientist and other personnel responsible for the commercialization of the finished dosage forms of these new biopharmaceuticals and other products from biotechnology. This text will help to fill this gap. Once active biopharmaceutical molecules are candidates for clinical trial investigation and subsequent commercialization, a number of other activities must take place while research and development on these molecules continues. The active ingredient itself must be formulated into a finished dosage form that can be conveniently used by health care professionals and patients. Properties of the biopharmaceutical molecule must be clearly understood so that the appropriate finished product formulation can be developed. Finished product formulation development includes not only the chemical formulation, but also the packaging system, the manufacturing process, and appropriate control strategies to assure such good manufacturing practice attributes as safety, identity, strength, purity, and quality.
Author: Danny Busch Publisher: Oxford Eu Financial Regulation ISBN: 9780198767671 Category : Law Languages : en Pages : 0
Book Description
PART I: GENERAL ASPECTS 1: Introduction, Danny Busch and Guido Ferrarini PART II: INVESTMENT FIRMS AND INVESTMENT SERVICES 2: The Scope of MiFID II, Kitty Lieverse 3: Governance of Investment Firms under MiFID II, Jens-Hinrich Binder 4: The Overarching Duty to Act in the Best Interest of the Client in MiFID II, Luca Enriques and Matteo Gargantini 5: Product Governance and Product Intervention, Danny Busch 6: Independent Financial Advice, Paolo Giudici 7: Conflicts of Interest, Stefan Grundmann and Philipp Hacker 8: Inducements, Larissa Silverentand, Jasha Sprecher, and Lisette Simons 9: Agency and Principal Dealing Under MiFID, Danny Busch 10: MiFID II/MiFIR's Regime for Third-Country Firms, Danny Busch & Marije Louisse PART III: TRADING 11: TGovernance and Organization of Trading Venues: The Role of Financial Market Infrastructures Groups, Guido Ferrarini & Paolo Saguato 12: EU Financial Governance and Transparency Regulation: A Test for the Effectiveness of Post-Crisis Administrative Governance, Niamh Moloney 13: SME Growth Markets, Carmine di Noia & Rudiger Veil 14: Dark Trading Under MiFID II, Peter Gomber & Ilya Gvozdevskiy 15: Derivatives: Trading, Clearing, STP, Indirect Clearing, and Portfolio Compression, Rezah Stegeman & Aron Berket 16: Commodity Derivatives, Antonella Sciarrone Alibrandi & Edoardo Grossule 17: Algorithmic Trading and High Frequency Trading, Pierre-Henri Conac 18: An American perspective, Merritt Fox PART IV: SUPERVISION AND ENFORCEMENT 19: Public Enforcement of MiFID II, Christos Gortsos 20: The Private Law Effect of MiFID: the Genil Case and Beyond, Danny Busch PART V: THE BROADER VIEW AND THE FUTURE OF MIFID 21: MiFID II: Picking up the Crumbs of a Piecemeal Approach, Veerle Colaert 22: Shadow Banking and the Functioning of Financial Markets, Eddy Wymeersch 23: Investment-based Crowdfunding: Is MiFID II enough?, Guido Ferrarini & Eugenia Macchiavello.
Author: John Geigert
Author: John Geigert
Author: John Geigert
Author: Feroz Jameel
Author: Ralf Pörtner
Author: Ved Srivastava
Author: Robert James Cimasi
Author: Robert James Cimasi
Author: Maria Cristina Galli
Author: Steve L. Nail
Author: Danny Busch