An Introduction to Bioanalysis of Biopharmaceuticals (eBook)
IX, 160 Seiten
Springer International Publishing (Verlag)
978-3-030-97193-9 (ISBN)
The book provides a comprehensive review of the fundamental and practical aspects of bioanalytical support and the integral role it plays in the development of safe and efficacious biopharmaceutical drugs with speed and cost-effectiveness. The book focuses on a broad range of conventional and emerging biopharmaceutical modalities including monoclonal antibody-based therapeutics, gene therapy, cell therapy, peptides and oligonucleotides.
The book further diversifies into individual biopharmaceutical modalities - monoclonal antibodies, antibody-drug conjugates, bispecifics, Fc-fusion proteins, gene therapies, cell therapies, peptides and oligonucleotides. The individual chapters focus on modality-specific bioanalytical assay strategies, critical reagents, assay formats, analytical platforms, associated bioanalytical challenges and mitigation strategies, industry best practices, and the latest understanding of regulatory guidance as applicable to the fast-growing biopharmaceutical landscape.
Seema Kumar is currently Director and senior DMPK lead at EMD Serono Inc. (a business of Merck KGaA, Germany). In her role, Dr. Kumar leads the Clinical Bioanalytical Sciences group that provides Bioanalysis (BA), Immunogenicity and DMPK support for clinical stage large molecule portfolio. Additionally as a senior DMPK lead, Dr. Kumar provides overall drug disposition support for large molecules spanning across discovery and development stages of the program. Previously, Dr. Kumar led regulated Bioanalytical group in BioMedicine Design (formerly PDM) at Pfizer. The group provided regulated (GLP/GCP) BA support including assay development, validation and sample analysis for PK and Immunogenicity (ADA and Nab) assessment of Pfizer's large molecule portfolio. Prior to joining Pfizer, Dr. Kumar served at roles of increasing responsibility as Director of Quality Control and Director of CLIA certified Clinical Bioanalytical Lab at XBiotech USA Inc.
Dr. Kumar holds a Ph.D. from Johns Hopkins University and has published several publications in peer-reviewed journals and contributed to several book chapters. Dr. Kumar has given numerous invited talks in various national and international scientific conferences and meetings and is an active member of industry consortia (IQ, AAPS etc.)..
Erscheint lt. Verlag | 23.8.2022 |
---|---|
Reihe/Serie | AAPS Advances in the Pharmaceutical Sciences Series | AAPS Advances in the Pharmaceutical Sciences Series |
Zusatzinfo | IX, 160 p. 25 illus., 19 illus. in color. |
Sprache | englisch |
Themenwelt | Naturwissenschaften ► Biologie |
Naturwissenschaften ► Chemie | |
Schlagworte | Antibody Drug Conjugates (ADCs) • Bispecific Fusion • drug development • gene therapy • monoclonal antibodies • Oligonucleotides • Peptides • Protein therapy • Vaccine development |
ISBN-10 | 3-030-97193-7 / 3030971937 |
ISBN-13 | 978-3-030-97193-9 / 9783030971939 |
Haben Sie eine Frage zum Produkt? |
![PDF](/img/icon_pdf_big.jpg)
Größe: 5,0 MB
DRM: Digitales Wasserzeichen
Dieses eBook enthält ein digitales Wasserzeichen und ist damit für Sie personalisiert. Bei einer missbräuchlichen Weitergabe des eBooks an Dritte ist eine Rückverfolgung an die Quelle möglich.
Dateiformat: PDF (Portable Document Format)
Mit einem festen Seitenlayout eignet sich die PDF besonders für Fachbücher mit Spalten, Tabellen und Abbildungen. Eine PDF kann auf fast allen Geräten angezeigt werden, ist aber für kleine Displays (Smartphone, eReader) nur eingeschränkt geeignet.
Systemvoraussetzungen:
PC/Mac: Mit einem PC oder Mac können Sie dieses eBook lesen. Sie benötigen dafür einen PDF-Viewer - z.B. den Adobe Reader oder Adobe Digital Editions.
eReader: Dieses eBook kann mit (fast) allen eBook-Readern gelesen werden. Mit dem amazon-Kindle ist es aber nicht kompatibel.
Smartphone/Tablet: Egal ob Apple oder Android, dieses eBook können Sie lesen. Sie benötigen dafür einen PDF-Viewer - z.B. die kostenlose Adobe Digital Editions-App.
Buying eBooks from abroad
For tax law reasons we can sell eBooks just within Germany and Switzerland. Regrettably we cannot fulfill eBook-orders from other countries.
aus dem Bereich