From excipient screening to ready-to-ship vials—Aquaterra transforms bulk drug substance into stable, patient-ready product under one roof.
Quick Facts
- Formats: 1 mL–50 mL vials, syringes, or cartridges
- Compounding Suites: 200 L (single-use & stainless steel)
- Sterility Assurance: ≤ 0.1 cfu/10 mL on every lot
- Fill-Weight Accuracy: ± 1 % via in-line mass-flow control
- Lyophilizer Capacity: 25 m² shelf area; dual-chamber cycle control
- Cold-Chain Storage: –80 °C freezers and liquid N₂ validated for global shipping
Integrated Workflow
- Formulation Development
- High-throughput DoE excipient screens
- Viscosity & osmolality mapping
- Accelerated stress tests to lock in optimal pH and tonicity
- Compounding & Sterile Filtration
- Closed single-use mixers with nitrogen overlay
- 0.22 µm final filters and in-line FTIR for real-time concentration verification
- Aseptic Fill
- Isolator-based rotary piston pumps for liquids and vacuum-stoppering for lyophilized formats
- Throughput up to 200 vials/min
- Lyophilization & Cycle Optimization
- PAT-guided shelf-freeze ramp rates and capacitance-probe end-point detection
- Annealing steps tailored for fragile biologics
- Inspection, Serialization & Labeling
- 100 % visual inspection (semi-automated or manual)
- GS1 serialization and tamper-evident labeling
- Validated packaging for air or sea freight
Why Aquaterra?
- Zero-Defect Mindset – Isolator technology, automated environmental monitoring, and real-time EM analytics keep media-fill failure rate below 0.05 %.
- Regulatory Fluency – ICH Q1/Q5C stability protocols and eCTD-ready batch records accelerate INDs, BLAs, and MAA filings.
- Speed-to-Clinic – Co-located formulation, fill-finish, and QC labs shave 4–6 weeks off traditional CMO timelines.