HPAPI expansion for AGC

Japanese CDMO AGC Pharma Chemicals has announced a “significant” expansion of its high potency API (HPAPI) capabilities in Barcelona. The investment will adapt the company’s entire development and manufacturing chain to OEB5 standards (0.1–1 µg/m3 over an eight-hour shift).  

AGC said that this was driven by growing demand for HPAPIs in oncology, targeted therapies, and personalised medicine, and will enable it to offer “seamless scale-up from grams to tonnes within a single integrated ecosystem”. In addition to existing multi-purpose kilo lab facilities equipped with OEB5 containment systems, it will add: 

* A new R&D laboratory, operational from March, featuring advanced OEB5 containment systems 

* New IPC and QC laboratories, also operational from March and supporting all development phases 

* A manufacturing facility, operational in 2H, with an OEB5 HPAPI bay with reactors volumes of 1.5 m3