Small-scale Manufacturing Infrastructure
The Small-scale Manufacturing area at NewAtom is designed to support process scale-up, validation batches, and early-phase GMP production, including operations requiring high automation and controlled cleanroom environments.
- Multiple reactors with volumes ranging from 50 L to 630 L
- Cleanroom with multiple small reactors and downstream equipment for isolating APIs/NCEs
- Materials of Construction: Glass-Lined Reactors (GLR) and Stainless Steel (SS)
- Comprehensive downstream processing including ANFD, centrifuges, tray dryers, RCVD, VTD, milling, micronization
Large-scale
Manufacturing Infrastructure
The Large-Scale Manufacturing area at NewAtom is designed to support manufacturing and process validation of late-phase intermediates and drug substance (API) for clinical and commercial supply
- Multiple reactors with volumes ranging from 630 L to 6.3 KL
- Hydrogenation block with reactors from 500 L to 3.0 KL and for pressures up to 60 kg/cm²
- 3 cleanroom with dedicated reactors and downstream equipment for drug substance manufacturing
- Materials of Construction: GLR, SSR and Hastelloy
- Dedicated Solvent Recovery Block
- Temperature range: −80°C to 200°C
- Comprehensive downstream processing including ANFD, centrifuges, tray dryers, RCVD, VTD, milling, micronization
Expansion Readiness & Future Capacity
Existing blocks have pre-engineered slots ready to accommodate 16 additional reactors.
13-acre campus supports construction of up to three additional manufacturing blocks, including dedicated product- or customer-specific blocks.
Quality Block
All quality systems, processes, and controls are fully aligned with current GMP requirements and ICH guidelines, ensuring robust data integrity, consistent product quality, and ongoing regulatory readiness.
The 32,000 sq. ft. Quality Block houses NewAtom’s QA and QC teams and is equipped with state-of-the-art analytical instrumentation:
- HPLCs
- GCs & GC-HSs
- Prep-HPLC
- Polarimeter
- Coulometer
- KF Titrator
- Auto Titrator
- Stability Chamber
- Analytical Balances
- FT-IR
All equipment are 21 CFR compliant and chromatography instruments are connected to Empower server.
