The Challenge of CMC Regulatory Compliance...

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Beschreibung

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 incan 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.

Über den Autor

John Geigert is President of BioPharmaceutical Quality Solutions, which specializes in providing CMC regulatory strategy consulting for the biopharmaceutical and biologic industry. Dr. Geigert has over 35 years of CMC industrial experience and leadership in the biopharmaceutical industry. Dr. Geigert has served on the PDA Board of Directors, co-chaired the PDA Biotech Advisory Board and served as an expert member of the USP Biotechnology Committee. Dr. Geigert has written extensively for the Regulatory Affairs Professional Society (RAPS) Focus (What Senior Management Needs to Know About CMC Regulatory Compliance for Biotech Products (Aug-Nov 2009, 4-part series) and Demystifying CMC Regulatory Strategy (Sept 2011-Mar 2012, 4-part series)).

Inhaltsverzeichnis

Biopharmaceutical Landscape.- Regulatory Pathways Impacting Biopharmaceuticals.- Differences in CMC Regulatory Compliance: Biopharmaceuticals Versus Chemical Drugs.- Risk Management of the Minimum CMC Regulatory Compliance Continuum.- Ever-Present Threat of Adventitious Agent Contamination.- Starting Materials for Manufacturing the Biopharmaceutical Drug Substance.- Upstream Production of the Biopharmaceutical Drug Substance.- Downstream Purification of the Biopharmaceutical Drug Substance.- Manufacturing the Biopharmaceutical Drug Product.- Complex Process-Related Impurity Profiles.- Seemingly Endless Biomolecular Structural Variants.- Indispensable Potency (Biological Activity).- Biopharmaceutical Critical Quality Attributes.- The Art of Setting Biopharmaceutical Specifications - Release and Shelf-Life.- The Challenge of Demonstrating Biopharmaceutical Product Comparability.- Strategic CMC-Focused Interactions with Regulatory Authorities.

Details

Erscheinungsjahr:	2024
Fachbereich:	Gentechnologie
Genre:	Biologie , Mathematik , Medizin , Naturwissenschaften , Technik
Rubrik:	Naturwissenschaften & Technik
Medium:	Taschenbuch
Inhalt:	xxxv 573 S. 1 s/w Illustr. 573 p. 1 illus.
ISBN-13:	9783031319112
ISBN-10:	3031319117
Sprache:	Englisch
Einband:	Kartoniert / Broschiert
Autor:	Geigert, John
Auflage:	Fourth Edition 2023
Hersteller:	Springer Springer International Publishing AG
Verantwortliche Person für die EU:	Springer Verlag GmbH, Tiergartenstr. 17, D-69121 Heidelberg, juergen.hartmann@springer.com
Maße:	235 x 155 x 33 mm
Von/Mit:	John Geigert
Erscheinungsdatum:	16.06.2024
Gewicht:	0,914 kg