Contract Development & Manufacturing (CDMO) for HPAPI (High Potency APIs)

Evonik is a global leader in the development and large-scale manufacturing of highly potent active pharmaceutical ingredients (HPAPIs). With decades of experience, we support pharmaceutical innovators in scaling complex HPAPI projects from lab to commercial volumes—safely, efficiently, and reliably.

HPAPIs are active pharmaceutical ingredients that require very low doses to achieve their therapeutic effect. They are commonly used in oncology, autoimmune disorders, and targeted therapies. Due to their potency, even trace exposure can pose health risks, making specialized containment and handling essential.

HPAPIs are increasingly vital in modern drug development, especially in oncology and targeted therapies. Their potency demands specialized containment, advanced technologies, and rigorous safety protocols.

OEL refers to the maximum amount of a substance that workers can be exposed to safely over a defined period. HPAPIs often require containment down to extremely low OELs—sometimes as low as 5 ng/m³—to protect personnel and prevent cross-contamination.

Manufacturing HPAPIs demands:

• Specialized containment infrastructure
• Advanced safety protocols and training
• Proven regulatory compliance
• Scalable technologies for complex synthesis

Partnering with a CDMO like Evonik gives you access to all of this—without the need to invest in costly infrastructure or navigate regulatory hurdles alone.

Producing HPAPIs involves unique challenges:

• Containment: Preventing exposure and contamination
• Complex synthesis: Multi-step reactions requiring precision
• Scale-up: Transitioning from lab to commercial volumes
• Waste management: Safe disposal of potent materials
• Regulatory compliance: Meeting global standards for safety and quality

Evonik addresses these challenges with a combination of differentiating technologies, rigorous safety systems, and global manufacturing capabilities.

We offer seamless scale-up from grams to commercial batch sizes exceeding 450 kg, supported by:

Tippecanoe site (Indiana, U.S.)

• Capacity: 170 m³
• Simultaneous production of six HPAPIs
• Containment down to OEL of 0.1 μg/m³
• Designed to prevent cross-contamination and ensure worker safety

Hanau site (Germany)

• Development and manufacturing under GMP and non-GMP conditions
• Containment down to OEL of 5 ng/m³
• Ideal for complex, multi-step synthesis and early-phase development

Evonik’s HPAPI capabilities are powered by a broad technology portfolio, including:

• Catalysis
• Microbial fermentation
• Biocatalysis
• Continuous processing
• Chemistry in water
• Advanced processes
• Chiral chemistry
• Cryogenic chemistry
• Crystallization
• Chromatography

These technologies enable efficient, safe, and scalable production of even the most challenging HPAPIs.

Evonik sets industry standards in containment, hygiene, and risk management:

• Comprehensive safety assessments for each synthesis step
• Advanced cleaning and waste treatment systems
• On-site solids and liquids incineration
• Strong audit track record and regulatory compliance

Whether you're developing a new oncology drug or scaling a complex molecule, Evonik offers:

• Proven expertise in HPAPI development and manufacturing
• Global network of FDA/EU-inspected cGMP sites
• Flexible support from clinical to commercial scale
• Collaborative project teams with deep technical knowledge