Scaling an API from grams in the laboratory to commercial production introduces new challenges at every stage — from maintaining process efficiency and consistent quality to controlling costs and meeting regulatory requirements. For HPAPIs, specialized containment adds another layer of complexity.
More Than Increasing Volume
Successful scale-up means understanding how a process changes as volumes grow. Heat transfer, mixing, equipment, yield and process parameters can behave differently at larger scales, making early process understanding critical to avoiding costly rework and delays.
Fragmenting development across different partners can add further risk through repeated technology transfers and potential knowledge loss.
AGC Pharma Chemicals: From Development to Commercial Scale
AGC Pharma Chemicals supports API and HPAPI projects from Phase I through commercial manufacturing, and from grams to tons, combining process development, scale-up and manufacturing within an integrated approach.
Discover how to address the key challenges of API and HPAPI scale-up while optimizing cost, time, quality and process performance in our White Paper.
