{"id":17,"date":"2020-01-30T09:11:58","date_gmt":"2020-01-30T09:11:58","guid":{"rendered":"https:\/\/www.almacgroup.com\/api-chemical-development\/?page_id=17"},"modified":"2025-11-19T09:04:06","modified_gmt":"2025-11-19T09:04:06","slug":"late-phase-api-development-and-manufacture","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/api-chemical-development\/late-phase-api-development-and-manufacture\/","title":{"rendered":"Late Phase API Development and Manufacture"},"content":{"rendered":"\n

Supporting Late Phase API Development and Commercial Launch<\/h4>\n\n\n\n

We have an established reputation for developing processes for clinical and commercial API manufacture. Our extensive experience lies in taking processes from inception through to process validation, both in small molecule chemistry and  peptides.<\/p>\n\n\n\n

As an API moves from early clinical phase towards late clinical phase, the emphasis of the project changes. Whereas in early clinical supply, a lean fit-for-purpose approach is appropriate, other factors start to dominate when moving towards late phase, particularly process efficiency and knowledge. We strategically integrate the principles from regulatory guidelines (FDA, ICH, USP), such as risk management and quality by design, as a basis for development and manufacturing strategies.<\/p>\n\n\n\n

Chemical Development<\/h4>\n\n\n\n

To improve process efficiency, our chemists can perform process optimisation and intensification with the goal of increasing yields, reducing raw materials and waste, and simplifying process operability. Once the process starts to become established, the focus changes so that knowledge and understanding become the primary objectives, ensuring the process is robust.<\/p>\n\n\n\n

Implementation of the following themes include:<\/h4>\n\n\n\n