{"id":11,"date":"2020-01-30T09:09:44","date_gmt":"2020-01-30T09:09:44","guid":{"rendered":"https:\/\/www.almacgroup.com\/api-chemical-development\/?page_id=11"},"modified":"2025-11-19T09:01:04","modified_gmt":"2025-11-19T09:01:04","slug":"early-phase-development-and-manufacture","status":"publish","type":"page","link":"https:\/\/www.almacgroup.com\/api-chemical-development\/early-phase-development-and-manufacture\/","title":{"rendered":"Early Phase Development and Manufacture"},"content":{"rendered":"\n

Process Development <\/h4>\n\n\n\n

Small molecule API process development studies provide insight to improve process efficiency with the goal of increasing yields, reducing raw materials and waste, and simplifying process operability. This critical activity identifies at the early phase development stage, potential quality issues which could impact successful drug substance scale-up and clinical manufacture.<\/p>\n\n\n\n

We have significant experience in early stage scale-up of APIs. Starting with the medicinal chemistry route, our chemists identify the most pressing parts of the chemistry to develop. Within this chemical development phase, the thermal safety of each process is assessed in-house by the DSC and ARSST and the heat of reaction data is measured by calorimetry.<\/p>\n\n\n\n

Purity control is assured by a combination of reaction progress control and the development of an effective and scalable purification strategy. Our chemists work closely with our development analysts and production teams to ensure that controls are appropriately embedded into the process IPCs, intermediate specifications, and processing instructions.<\/p>\n\n\n\n

API Analytical Development<\/h4>\n\n\n\n

Successful pharmaceutical API development requires a strong analytical team. Our expert analysts are experienced in the development and phase appropriate validation of sensitive and specific analytical methods. Our seasoned analysts work closely with our chemists to develop IPC, isolated intermediate, and stability indicating API methods. Underpinning this work is a strong investment in a wide range of analytical equipment, including ongoing investment in equipment and software that increases the efficiency of our analytical workflows.<\/p>\n\n\n\n

We have vast experience in the development of highly sensitive methods to demonstrate control of potential GTIs. Our stability teams work alongside our development analysts, routinely running multiple parallel API and drug product stability studies.<\/p>\n\n\n\n

Integrated CMC Solutions<\/h4>\n\n\n\n

Almac addresses the growing industry need to develop & manufacture clinical candidates faster by providing an integrated CMC solution, bridging the gap between drug substance<\/a> and drug product development<\/a>.<\/p>\n\n\n\n

By offering these services within an integrated package, our client partners are assured of scientific continuity from a dedicated project team, from a single source, resulting in significant savings in both time and costs. Learn more.<\/a><\/p>\n\n\n\t

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Make an enquiry<\/h3>\n\n\t\t\t\t\t<\/div>\n\t\t\t\t<\/div>\n\t\t\t<\/div>\n\t\t<\/div>\n\n\t\n","protected":false},"excerpt":{"rendered":"

Process Development Small molecule API process development studies provide insight to improve process efficiency with the goal of increasing yields, reducing raw materials and waste, and simplifying process operability. This critical activity identifies at the early phase development stage, potential quality issues which could impact successful drug substance scale-up and clinical manufacture. We have significant […]<\/p>\n","protected":false},"author":1,"featured_media":0,"parent":0,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-11","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"\nEarly Phase Development and Manufacture - API Services & Chemical Development<\/title>\n<meta name=\"description\" content=\"Significant experience in the first time scale-up of APIs. 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