The goal of consistently achieving critical quality attributes (CQAs) for synthetic peptide active pharmaceutical ingredients (APIs) may be challenging owing to the complexity of the manufacturing process and the large number of potential sources of variability. This chapter outlines the principles of process design and the development of a comprehensive control strategy for manufacturing peptide APIs of consistent quality. A approach is described that involves process design utilizing a practical application of quality target product profile (QTPP), quality-by-design (QbD), identification and mitigation of risks and process characterization.
A. Swietlow and A. Lower, ed. Royal Society of Chemistry, London, UK, 2019, 194
The necessary cookies help to make a website usable by enabling basic functions such as page navigation and access to secure areas of the website. The website cannot function properly without these cookies.
Marketing cookies are used to track visitors through websites. The goal is to display ads that are relevant and interesting to the individual user and therefore more valuable to third-party publishers and advertisers.
Statistical cookies help website owners, through the anonymous collection and communication of information, to understand how visitors interact with websites.
Preferences cookies allow a website to retain information that changes the way the site behaves or displays, such as your preferred language or the region in which you are located.