OneHP Development & Manufacturing
Aragen’s OEB-6 High-Potent Platform
Engineered for Oncology and Beyond—OEB 6 Excellence in Development & Manufacturing
High potent molecule (HPs) are at the forefront of breakthrough therapies — often effective at single-digit microgram or nanogram doses. That exceptional potency demands deep expertise, advanced containment and uncompromising safety to protect both your product and your people.
Aragen has invested deeply to build a world-class OEB-6 containment OneHP platform, designed to meet and exceed industry expectations. Classified as an Oncology Block under Indian regulatory standards, it is engineered for far more: a versatile, multipurpose platform for the broadest range of HP molecule — from cytotoxic oncology compounds to potent molecules across autoimmune, hormonal, antiviral and other therapeutic areas.
With over 10 years of experience developing and manufacturing HP molecule , our teams provide end-to-end support to global pharmaceutical innovators — from early-stage synthesis to clinical and commercial GMP manufacturing.
HPAPI Exposure Classification Pyramid
Integrated Capabilities from Process Development to Commercial Supply
A fully integrated platform supports your HP molecule project from early research through commercial manufacturing. By housing development and manufacturing under one roof, we minimize external tech transfer — reducing risk and timelines, increasing process control and ensuring regulatory compliance at every step.
| Stage | Capabilities & Scale | What It Means for You |
|---|---|---|
| Process development | Scale-up to 250gm | Optimize and validate processes before GMP transition, reducing risk and cost |
| GMP manufacturing | Clinical and commercial batches from 250gm 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 | Safe, compliant operations across all processing areas |
Containment & Environmental Controls
Multiple layers of engineering and procedural containment enable safe processing of compounds with occupational exposure limits (OELs) up to 10ng/m³, delivering strong operator protection and product integrity.
- OEB-6-rated engineering controls: designed to manage the most potent and hazardous APIs safely
- 11 closed-system isolators: for all critical material handling, reducing contamination and exposure risks
- Dedicated HVAC systems: strict pressure cascades and safe HEPA filter changes with Bag-In/Bag-Out technology
- Wet scrubbers and closed waste systems: effective emissions control and validated detoxification protocols that protect the environment and your compliance profile
- Personnel and material segregation: airlocks, pass boxes, mist showers and enforced PPE/RPE protocols
Skilled Experts Committed to Your Success
- Specialized workforce: highly trained operators, engineers, quality assurance professionals and safety specialists, all experienced in HP molecule handling and GMP compliance — ensuring precise execution from material preparation to final packaging, in strict adherence to safety standards
- Dedicated project teams: cross-functional teams aligned to each project, from route scouting through commercial manufacturing
- Continuous training and safety culture: rigorous training programs and robust safety protocols uphold the highest standards of process control and occupational health — giving you peace of mind at every stage
Committed to Quality and Regulatory Excellence
At Aragen, quality isn’t a checklist — it’s a culture. Our facility adheres strictly to US FDA, EMA, PMDA and DCGI standards, supported by:
- Frequent internal and external audits
- Cross-functional quality and safety reviews
- Comprehensive documentation and validation for seamless regulatory submissions
You gain a partner who understands global regulatory landscapes — and helps you navigate them with confidence.
Why Aragen: Your End-to-End Partner for High-Potent molecule Development
Your End-to-End Partner for High-Potency API Development
From milligram-scale synthesis to multi-kilogram GMP production, Aragen offers a streamlined, risk-mitigated path to market — combining safety, speed and scientific rigor to advance your high-potency programs with confidence.
- OEB-6 Excellence: Containment and safety systems for the most potent compounds
- Therapeutic Versatility: Oncology, autoimmune, hormonal, antiviral and other high-potency areas
- Global Quality Standards: US FDA, EMA, PMDA and DCGI — backed by robust QA and regulatory support
- Scalable Infrastructure: Ongoing investment in advanced OEB-5/OEB-6 capacity to support your pipeline growth
Contact us to learn more about our High Potent molecule capabilities and how we can support your HP molecule projects.
