Peptide Therapeutics - Strategy and Tactics for Chemistry, Manufacturing, and Controls (Hardcover)

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.

General

Imprint:	Royal Society of Chemistry
Country of origin:	United Kingdom
Series:	Drug Discovery, Volume 72
Release date:	August 2019
First published:	2019
Editors:	Ved Srivastava
Dimensions:	234 x 156 x 37mm (L x W x T)
Format:	Hardcover - Unsewn / adhesive bound
Pages:	543
ISBN-13:	978-1-78801-433-5
Categories:	Books > Science & Mathematics > Biology, life sciences > Molecular biology Books > Medicine > Other branches of medicine > Pharmacology > General Books > Science & Mathematics > Chemistry > Organic chemistry > General Books > Science & Mathematics > Biology, life sciences > Biochemistry > Proteins
LSN:	1-78801-433-2
Barcode:	9781788014335

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