AGC Pharma Chemicals Expands HPAPI Capabilities in Barcelona

• AGC Pharma Chemicals is expanding its High Potency Active Pharmaceutical Ingredients (HPAPI) capabilities in Barcelona, enabling scale-up from grams to tons.

• The new facilities, operational from 2025, will enhance containment and production standards to meet rising global demand in oncology and targeted therapies.

AGC Pharma Chemicals, a CDMO specialising in small molecule API manufacturing, has announced a major expansion of its High Potency Active Pharmaceutical Ingredients (HPAPI) capabilities in Barcelona. The development will establish a fully integrated ecosystem, allowing seamless scale-up from early-phase development to commercial manufacturing.

The expansion responds to increasing demand for HPAPIs, particularly in oncology and targeted therapies, where highly potent compounds play a crucial role in advancing precision treatments. The global HPAPI market, valued at USD 25.38 billion in 2024, is projected to reach USD 47.44 billion by 2031, growing at a CAGR of 8.13%.

The new facilities will include an R&D laboratory and IPC/QC laboratories, both operational from March 2025, as well as an advanced manufacturing facility featuring an OEB5 HPAPI bay with 1.5 m³ reactor volumes, set to launch in the second half of 2025. These enhancements will ensure end-to-end containment capabilities, adhering to OEB5 standards (0.1–1 µg/m³ over an 8-hour shift).

“Our integrated approach represents AGC’s commitment to supporting the complete HPAPI development journey,” stated Akihiro Kadokura, CEO at AGC Pharma Chemicals. “By offering an uninterrupted chain of capabilities together, we enable our partners to advance their high-potency compounds from initial grams through commercial tons, all within a single, trusted ecosystem.”

With this expansion, AGC Pharma Chemicals reinforces its role as a key player in pharmaceutical process development and contract manufacturing, providing a comprehensive solution for advancing high-potency compounds from early-stage development to commercial-scale production.