Manufacturing infrastructure
End-to-End Manufacturing Capabilities
Two GMP-certified facilities in the Dallas–Fort Worth metroplex, equipped for sterile fill-finish, lyophilisation, peptide synthesis, and large-scale biologics production.
Combined facility footprint
ISO-classified cleanrooms
Units annual capacity
Sterility assurance level
What We Can Do For You
Sterile Fill-Finish
Aseptic filling of vials, syringes, and cartridges in ISO 5 environments. Supports aqueous solutions, suspensions, and lyophilised products up to 500,000 units per batch.
- ISO 5 / Class 100 filling suites
- Vials: 2 mL – 100 mL
- Pre-filled syringes: 0.5 mL – 5 mL
- Automated visual inspection
Lyophilisation
Freeze-drying services for biologics requiring enhanced stability. Multiple lyophiliser units with validated cycles for peptides, proteins, and small molecules.
- 4 production-scale lyophilisers
- Shelf area: up to 40 m²
- Validated cycle development
- Residual moisture testing
Peptide Synthesis
Solid-phase peptide synthesis (SPPS) at milligram to kilogram scale. Fmoc and Boc chemistry with full analytical characterisation and GMP batch records.
- Fmoc / Boc SPPS
- Scale: 1 g – 5 kg per batch
- HPLC purity ≥ 98%
- Full MS characterisation
Quality Control Laboratory
In-house QC laboratory with HPLC, LC-MS, Karl Fischer titration, endotoxin testing, and full microbiological suite for release and stability testing.
- USP-compliant methods
- Endotoxin (LAL) testing
- Sterility testing suite
- Stability chambers (ICH zones)
Cold Chain Management
Validated cold chain infrastructure from manufacturing through distribution. Dedicated 2–8°C and -20°C storage with 24/7 temperature monitoring and alarm systems.
- 2–8°C refrigerated storage
- -20°C and -80°C freezer banks
- Qualified shipping containers
- Real-time temperature logging
Autoinjector & Pen Assembly
Assembly and packaging of autoinjector devices, insulin pens, and prefilled delivery systems. Supports both proprietary and licensed device platforms.
- Insulin pen assembly
- Autoinjector integration
- Cartridge filling
- Device functionality testing
Ready to discuss your manufacturing needs?
Our technical team can assess feasibility, timelines, and capacity for your programme.
Request a Capabilities Review