HPAPIs (Highly Potent Active Pharmaceutical Ingredients) are compounds with strong pharmacological activity at very low doses — often in the microgram range. These molecules are increasingly used in oncology, autoimmune disorders, hormonal therapies, and targeted treatments, where therapeutic effects must be achieved with minimal systemic exposure.
Due to their potency, HPAPIs pose a significant occupational and cross-contamination risk, which requires:
- Specialized containment and isolation technologies (OEB4–OEB5 and beyond)
- Dedicated equipment and air-handling systems
- Rigorous cleaning validation and environmental monitoring
- Strict personnel protection and training protocols
The development and manufacture of HPAPIs demand a high level of technical, regulatory, and safety expertise, as well as facility design purpose-built for potent compound handling.
As global demand for HPAPIs grows, so does the need for reliable, compliant partners. AGC Pharma Chemicals is meeting this need with cutting-edge HPAPI capabilities in Europe, backed by decades of experience.
AGC Pharma Chemicals’ HPAPI Capabilities at a Glance
At AGC Pharma Chemicals, we provide end-to-end solutions for the development and manufacturing of Highly Potent Active Pharmaceutical Ingredients (HPAPIs).
Our Barcelona pharmaceutical plant is equipped with OEB5-level containment systems, enabling safe and compliant scale-up from lab-scale development to commercial production — with full cGMP adherence and operational excellence at every stage.
Our plant offers industry-leading HPAPI capabilities, including:
- A dedicated R&D laboratory with OEB5-grade containment.
- IPC and QC laboratories adapted for safe HPAPI sample handling and testing.
- A kilo lab with OEB5 containment for development and cGMP production.
- A multipurpose commercial-scale HPAPI production suite featuring a 1.5 m³ reactor bay and isolator technology.
This end-to-end infrastructure allows us to seamlessly scale HPAPI projects from grams to multi-ton production under full cGMP and safety compliance.
Why AGC Pharma Chemicals for HPAPI Manufacturing?
- Over 40 years of CDMO experience in small molecule API manufacturing
- Expanded HPAPI infrastructure in Europe, with OEB5 containment
- Proven audit success with FDA, EMA, PMDA, and other global regulators
- Flexible manufacturing capacity, from grams to full commercial volumes
- A strategic CDMO partner with global project management and scientific expertise
With AGC Pharma Chemicals, your HPAPI project benefits from specialized technology, regulatory strength, and a culture of Top Pharma Quality.
HPAPI FAQ’s
1. What types of HPAPIs can AGC Pharma Chemicals handle?
AGC Pharma Chemicals is equipped to handle highly potent small molecules API, up to OEB5 classification, under full cGMP and safety controls.
2. What is OEB5, and why is it important for HPAPI manufacturing?
OEB5 (Occupational Exposure Band 5) refers to compounds with very low acceptable operator exposure levels (typically 0.1–1 µg/m³). Our facilities are designed to safely manufacture these compounds using isolators, closed systems, and strict protocols.
3. Can AGC Pharma Chemicals support global regulatory filings for HPAPIs?
Yes. Our regulatory affairs team supports submissions in major markets, with a focus on HPAPI-specific compliance and documentation.
4.What makes AGC Pharma Chemicals a trusted CDMO partner for HPAPI manufacturing?
We combine technical depth, state-of-the-art containment, and a proven compliance record, with a client-centric approach that prioritizes highest quality, safety, and speed to market.
Let’s Talk About Your HPAPI Project
Looking for a trusted CDMO partner to develop and manufacture your high-potency API?
Contact AGC Pharma Chemicals today to explore how our purpose-built HPAPI facilities, expert teams, and full-service CDMO approach can support your program from lab to launch.
