OneHP: High-Potency API (HPAPI)
Development and Manufacturing Platform
OneHP by Aragen: One Platform. Ultra-High Containment.
Aragen OneHP is a high-potency API (HPAPI) platform in Hyderabad, India. It brings discovery chemistry, process development, analytics and cGMP manufacturing together in one purpose-built OEB-6 containment facility. OEB stands for occupational exposure band.
One partner and one quality system mean fewer handoffs between providers when a high-potency molecule moves from milligrams to multi-kilogram GMP supply.
Every handoff costs months — and momentum
High-potency molecules are now mainstream science: nearly 65% of oncology candidates in development are highly potent, and the global HP molecule market continues to grow.
Yet most programs still move between three separate partners — discovery chemistry, process development and GMP supply — re-qualifying containment and re-validating methods at every transfer. Add ADC ambitions, and few sites even qualify at the containment thresholds these molecules demand.
One partner. One containment standard. One quality system.
OneHP unifies discovery, development, analytical and cGMP manufacturing on a single integrated platform — so your high-potency molecule advances without ever changing hands.
Platform at a Glance
| Stage | Scale | Explore (Links) |
|---|---|---|
| Discovery Chemistry | Up to 10gm | OneHP Discovery → |
| Non-GMP Process Development & Scale-Up | Up to 500gm | OneHP Development & Manufacturing → |
| cGMP Manufacturing | 500 g to 5 kg per batch. Designed annual capacity about 500 to 600 kg. | OneHP Development & Manufacturing → |
Facility & Containment
- Purpose-built OEB-6 facility of about 15,000 sq ft in Hyderabad. Potent-compound handling systems with five levels of cascading protection support occupational exposure limits (OELs) up to 10 ng/m³.
- Ultra-high containment: potent-compound handling systems with five levels of cascading protection, supporting occupational exposure limits (OELs) up to 10 ng/m³
- SafeBridge qualified systems and operating procedures
Built for What’s Next: ADCs and Bioconjugation
OneHP supports antibody-drug conjugates (ADCs) and other potent drug conjugates. It provides linker-payload synthesis chemistry and, with Aragen’s antibody and protein production and bioconjugation services, supports discovery and development from linker-payload chemistry to conjugation. Discovery-scale ADC, PDC, DAC and AOC bioconjugation capabilities are being expanded
Outcomes That Matter to Your Program
Reduce Risk
One integrated partner from linker-payload design through conjugation and GMP supply — no vendor handoffs, no revalidation cycles, no re-onboarding of a new team at each stage.
Ensure Continuity
Experienced scientists guide payload selection, linker design and route strategy from day one — so scalability and containment are engineered in, not discovered late.
Accelerate Timelines
Knowledge follows your molecule. The same platform that synthesizes your first milligrams characterizes your conjugate and manufactures your kilograms.
