AGC Pharma Chemicals, a leading innovator in pharmaceutical manufacturing with over 40 years of expertise in Contract Development Manufacturing Operations (CDMO) for small molecule APIs based in Barcelona (Spain) and Japan, announces a significant expansion of its High Potency Active Pharmaceutical Ingredients (HPAPI) capabilities, enabling seamless scale-up from grams to tons within a single integrated ecosystem.
This strategic expansion in Barcelona addresses the growing demand for HPAPI driven by advances in oncology, targeted therapies, and personalized medicine, where highly potent compounds are essential for developing more precise and effective treatments. With the global HPAPI market valued at USD 25.38 Billion in 2024 and projected to reach USD 47.44 Billion by 2031, growing at a CAGR of 8.13%, this state-of-the-art facility backed by a significant investment, is set to redefine API production and set new global standards in pharmaceutical manufacturing excellence.
This strategic enhancement completes AGC Pharma Chemicals’ end-to-end HPAPI capabilities, establishing a comprehensive, fully integrated containment solution that seamlessly connects early-phase development through commercial manufacturing. As a CDMO with HPAPI capabilities from gram to tons, AGC has systematically adapted its entire development and manufacturing chain to OEB5 standards (0.1–1 µg/m³ over an 8-hour shift), from its new R&D facility through laboratory to commercial production, ensuring consistent containment capabilities throughout the entire process.
“Our integrated approach represents AGC’s commitment to supporting the complete HPAPI development journey,” states 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.”
The comprehensive HPAPI chain in Barcelona includes:
- A new R&D laboratory, operational from March 2025, featuring advanced OEB5 containment systems.
- New IPC/QC laboratories, operational from March 2025, supporting all development phases.
- Multi-purpose existing Kilolab facilities equipped with OEB5 containment systems.
- Advanced new manufacturing facility (operational second half of 2025) with an OEB5 HPAPI bay with reactors volumes of 1.5 m³.
This integrated enhancement of AGC’s HPAPI capabilities reinforces its position as a trusted partner in pharmaceutical process development and manufacturing, offering a truly unified solution for advancing high-potency compounds from initial grams through commercial-scale tons.
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