High-Potency API Development & cGMP Manufacturing
From preclinical discovery to commercial cGMP supply:
- Secure, compliant containment down to 20 ng/m3 (OEB 5 and beyond).
- State-of-the-art containment infrastructure in Budapest, backed by over a century of API synthesis expertise.
At-a-Glance: Core Capabilities
Our dedicated HPAPI workshop is designed to support projects from laboratory scale through early commercial production:
| Parameter | Specification & Range |
|---|---|
| Containment Classification | OEB 5/6 |
| Occupational Exposure Limit (OEL) | Safe handling down to20 ng/m3 |
| Reactor Capacities | 15 L, 30 L, and 60 L specialized reaction vessels |
| Batch Size | Up to 3 kg/batch |
| Project Lifecycle | Route-scoutingPreclinical, Phase I–III clinical trials, early commercial cGMP |
| Advanced Modalities | Highly-potent small molecules, peptide-like APIs and linkers, ADC linkers-payloads |
| Regulatory Authority Audits | US FDA, EMA, NNGYK |
HPAPI facility
End-to-End HPAPI Lifecycle Services
EUROAPI's dedicated HPAPI development services provide comprehensive support from process development through analytical characterization and process safety assessment:
Process Chemistry & Safety Screening
- Route scouting, retro-synthetic analysis, and hazard evaluation in specialized contained laboratories.
- Optimization under closed containment using specialized isolators and high-containment glove-boxes.Integrated Process Safety Assessments: reaction calorimetry (RC1/DSC), thermal runaway potential screening, and off-gas monitoring.
Analytical Development & QC
- Contained analytical development and advanced analytical characterization for effective impurity management throughout the HPAPI development lifecycle Robust in-process controls supported by high-resolution HPLC and GC ensuring process understanding, product quality, and regulatory compliance.
- Comprehensive cGMP release testing delivers reliable results for the safe and efficient release of high-potency APIs..
Clinical Supply & Early Commercial cGMP Production
- Smooth scale-up from gram-scale to multi-kilogram batches.
- Closed Barrier Processing and Isolator Systems Eliminating Cross-Contamination Risks in Multi-Product CampaignsRobust chemistry tech-transfer workflows designed to minimize lead time to clinic.
HPAPI Facilities
Engineering & Technology Architecture
Partnering with Euroapi give you guaranteed access the following advanced HPAPI processing technologies:
Advanced Containment Strategy
- High-Containment Isolator Technology: Rigid-wall, negative-pressure process isolators with continuous differential pressure monitoring ensure maximum operator protection and process integrity.
- Contained Material Handling: Ezi-Dock® closed-transfer technology enables safe charging, transfer, and dissolution of potent compounds without atmospheric exposure.
- Multi-Layer Containment: Cascading pressure zones, interlocked airlocks, and integrated mist-shower decontamination systems provide comprehensive environmental and personnel protection.
Integrated Processing & Purification Capabilities
- Flexible Reaction Systems: Glass-lined reactors (15 L, 30 L, and 60 L) designed for complex HPAPI synthesis across a wide range of process conditions.
- Contained Isolation & Drying: Agitated filter dryers and tray dryers integrated within isolators for safe, efficient product recovery.
- Solvent Removal: Fully contained 20 L rotary evaporator for secure concentration and solvent evaporation operations.
- High-Purity Chromatographic Purification: Preparative HPLC system equipped with a 100 mm DAC column for efficient purification of complex molecules.
- Contained Lyophilization: Closed-tray lyophilization technology ensures operator safety while preserving product quality and stability during isolation and discharge.
HPAPI Facilities
Specialized Modalities: Oligonucleotides, Peptides & ADC Linkers
Modern oncology and targeted therapies require specialized chemistry at the intersection of potency and biomolecular targeting. Leveraging decades of peptide expertise across our Budapest and Frankfurt sites, EUROAPI delivers specialized solutions for:
- Antibody-Drug Conjugate (ADC) Linkers: High-yield synthetic pathways and chromatographic purification of cleavable and non-cleavable ADC linkers.
- Peptide-Like HPAPIs: Complex hybrid architectures combining solid-phase peptide synthesis (SPPS) and liquid-phase fragment condensation under strict OEB 5/6 containment.
- Peptide-Drug Conjugates: Unlocking the potential of PDCs through advanced chemistry and scalable manufacturing
- Antibody-Oligonucleotide Conjugates: Empowering AOC programs with proven expertise in oligonucleotide and linker manufacturing
Ready to Advance Your HPAPI Program?
Partner with EUROAPI's highly potent API experts to accelerate development, strengthen containment strategy, and enable reliable manufacturing from preclinical studies to commercial supply.
HPAPI Facilities
Frequently Asked Questions for HPAPI
What types of HPAPIs can EUROAPI develop and manufacture?
With more than 100 years of experience in complex chemistry, EUROAPI combines deep scientific expertise with highly skilled and experienced teams to support the development and manufacture of a broad range of highly potent active pharmaceutical ingredients (HPAPIs). Our dedicated HPAPI facility is designed to enable the safe development and production of complex organic molecules, including cytotoxic compounds, ADC payloads, linker-payloads, and other highly potent small molecules.
What containment capabilities does EUROAPI offer for HPAPI projects?
EUROAPI’s dedicated HPAPI facility is designed to safely handle OEB 6 compounds, with containment capabilities qualified down to 20 ng/m³.
Can EUROAPI support both development and commercial manufacturing?
EUROAPI offers fully integrated development and manufacturing capabilities for highly potent compounds under contained conditions. Our dedicated HPAPI process development laboratory supports route scouting, process development, and the preparation of non-GMP samples, enabling rapid advancement from early-stage development to process optimization. Complementing these capabilities, EUROAPI's contained Kilolab provides cGMP manufacturing for the production of highly potent compounds, ensuring a seamless transition from development to clinical and commercial supply while maintaining the highest standards of containment, safety, and quality.
Does EUROAPI manufacture ADC linkers and linker-payloads?
EUROAPI has extensive capability for the manufacture of a broad range of linkers, including peptide- and PEG-based linkers, and their subsequent conjugation to cytotoxic payloads.
What production scale can EUROAPI support for HPAPI projects?
EUROAPI is equipped to manufacture highly potent compounds under full cGMP conditions at batch sizes ranging from 50 g to 3 kg. Complementing these capabilities, non-highly potent intermediates can be produced at scales of several hundred kilograms. To support process development activities, our specialized HPAPI laboratory provides non-GMP manufacturing of highly potent compounds up to 100 g scale.