Pilot lyophilizers for therapeutic proteins and clinical trials
For pharmaceutical and biotech industry, developing aggressive freeze-drying cycles for high-value products can be challenging. Handling small- to medium-batch production while ensuring high-quality lyophilization processes requires advanced technological solutions.
Ensures precise lyophilization with advanced control technologies
The Hull LyoConstellation S10, S20, and S30 Pilot Lyophilizers by SP Hull are designed to meet the most stringent lyophilization needs. Built to GMP standards, they integrate seamlessly into fill-finish workflows that require cleanroom-ready lyophilizers. Each unit can accommodate vials up to 30 mL and hold 100 mTorr while shelves are at +40°C when fully loaded. The LyoConstellation models come with 5, 6, or 8 shelves, offering flexibility for various throughput requirements. These lyophilizers are equipped with state-of-the-art technologies like controlled ice nucleation, fluid condenser cooling, and large diameter vapor ports for high vapor flow. The LyoConstellation also integrates with SP’s Line of Sight™ suite, enhancing process efficiency, quality, and consistency through the inclusion of SMART™ Freeze Dryer Technology, LyoFlux® 200 TDLAS Sensors, TEMPRIS® Wireless Sensors, and ControLyo® Nucleation Technology. Suitable for applications involving therapeutic proteins, ADC production for clinical trials, and compounding pharmacies, this lyophilizer supports efficient cycle development, scale-up stability, and full aseptic production. The validation ports and comprehensive documentation packages simplify the validation process, ensuring compliance and safety.
Benefits
- Supports aggressive freeze-drying cycles with precise control
- Integrates with Line of Sight™ PAT tools for enhanced process monitoring
- Capable of holding 100 mTorr with shelves at +40°C fully loaded
- Comes with 5, 6, or 8 shelves for flexible throughput
- Complete validation support with full documentation