Aragen’s High-Potency API Platform
Engineered for Oncology and Beyond—OEB 6 Excellence in Development & Manufacturing
In today’s pharmaceutical landscape, highly potent active pharmaceutical ingredients (HPAPIs) are at the forefront of breakthrough therapies—often effective at single digit microgram or nanogram doses. However, their exceptional potency demands unparalleled expertise, cutting-edge containment, and uncompromising safety to protect both your product and your people.
At Aragen, we understand these challenges—and have invested deeply to build a world-class OEB 6 containment HPAPI facility that not only meets but exceeds industry expectations. Classified as an Oncology API Block per Indian regulatory standards, our facility is engineered for far more. It’s a versatile, multipurpose platform designed to handle the broadest range of HPAPIs—from cytotoxic oncology compounds to potent molecules across autoimmune, hormonal, antiviral, and other therapeutic areas.
At Aragen, we offer end-to-end support for highly-potent active pharmaceutical ingredients (HPAPIs)—from early-stage synthesis to clinical and commercial GMP manufacturing. Designed to manage the challenges of handling potent compounds safely and efficiently, our facilities are equipped to handle compounds with OEL up to 0.01 µg/m3, ensuring operator safety and product integrity at every stage.
With over 10 years of experience in developing and manufacturing high-potency APIs, our teams support global pharmaceutical innovators across oncology, hormonal therapies, and other high-potency applications.
HPAPI Exposure Classification Pyramid
Comprehensive HPAPI Capabilities to Support Your Molecule’s Journey
At Aragen, we offer a fully integrated platform that supports your HPAPI project from early research through commercial manufacturing. Our robust infrastructure and seamless workflows minimize risks, accelerate timelines, and ensure regulatory compliance every step of the way.
| Development Stage | Capabilities & Scale | What It Means for You |
|---|---|---|
| Discovery & Synthesis | Early R&D at 1 mg to 100 mg | Rapid feasibility studies and route scouting for potent molecules with minimal material |
| Process Development | Scale-up to 250 g, non-GMP | Optimize and validate processes before GMP transition, reducing risk and cost |
| GMP Manufacturing | Clinical & commercial batches from 250 g to 5 kg | Reliable, scalable production aligned with global regulatory standards |
| Analytical & QC | In-house labs for method development, validation, and testing | Full regulatory support ensuring quality and compliance |
| Utilities & Services | Dedicated HVAC, wet scrubbers, pressure cascades, and containment infrastructure | Maintain safe, compliant operations across all processing areas; integrated under one roof to reduce timelines and tech transfer risks |
We minimize the need for external tech transfer by integrating development and manufacturing under one roof—reducing timelines and increasing process control.
Skilled Experts Committed to Your Success
State-of-the-Art Infrastructure Built for Safety and Flexibility
Containment & Environmental Controls
Ensuring Safety for Our Team and Your Molecules
Handling highly potent compounds requires rigorous safety, environmental, and contamination controls. At Aragen, our facility is designed with multiple layers of engineering and procedural containment, ensuring safe processing of compounds with occupational exposure limits (OELs) down to <0.01 µg/m³. Our facility features:
Committed to Quality and Regulatory Excellence
At Aragen, quality isn’t just a checklist—it’s a culture. Our facility adheres strictly to US FDA, EMA, PMDA, and DCGI standards. We implement:
You benefit from a partner who not only understands global regulatory landscapes but helps you navigate them confidently.
Why Aragen
Your End-to-End Partner for High-Potency API Development
From milligram-scale synthesis to multi-kilo GMP production, Aragen offers a streamlined, risk-mitigated path to market for your high-potency programs. With proven containment, experienced teams, and fully integrated capabilities, we offer:
Aragen combines safety, speed, and scientific rigor to advance your high-potency programs with confidence.
Contact us to learn more about our HPAPI capabilities and how we can support your HPAPI projects.
