An Introduction to Bioanalysis of Biopharmaceuticals (Hardcover, 1st ed. 2022)

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 starts with an introductory overview of bioanalysis showcasing the integral role it plays in understanding the drug disposition (pharmacokinetics/pharmacodynamics and immunogenicity) and the progression of bioanalytical strategy as the drug progresses through discovery and development stages of the program, taking into consideration the continually evolving regulatory landscape. 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.

General

Imprint:	Springer Nature Switzerland AG
Country of origin:	Switzerland
Series:	AAPS Advances in the Pharmaceutical Sciences Series, 57
Release date:	August 2022
First published:	2022
Editors:	Seema Kumar
Dimensions:	235 x 155mm (L x W)
Format:	Hardcover
Pages:	160
Edition:	1st ed. 2022
ISBN-13:	978-3-03-097192-2
Categories:	Books > Science & Mathematics > Chemistry > General Books > Medicine > Other branches of medicine > Pharmacology > General Books > Science & Mathematics > Biology, life sciences > Life sciences: general issues > General Books > Science & Mathematics > Biology, life sciences > Cellular biology > General Books > Professional & Technical > Industrial chemistry & manufacturing technologies > Industrial chemistry > Pharmaceutical technology
LSN:	3-03-097192-9
Barcode:	9783030971922

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