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Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls

Peptide Therapeutics: Strategy and Tactics for Chemistry, Manufacturing, and Controls

Hardcover

Series: Drug Discovery, Book 72

Medical ReferenceBiologyChemistry

ISBN10: 1788014332
ISBN13: 9781788014335
Publisher: Royal Society of Chemistry
Published: Aug 28 2019
Pages: 543
Weight: 2.20
Height: 1.40 Width: 6.40 Depth: 9.30
Language: English

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.

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