SP Scientific reports that AstraZeneca BioPharmaceuticals R&D (Gothenburg, Sweden) has invested in a LyoConstellation S10 freeze dryer intended to help drive research and development of small-scale GMP production. The SP Scientific LyoConstellation system is planned for use on multiple projects to support early to late phase development including GMP production of small batches for Phase 1 and Phase 2 clinical trials.
The LyoConstellation provides the flexibility in that it could be used aseptically within a GMP environment as well as for lyophilisation development in relation to the small-scale manufacture of parenteral products. SP Scientific offers a range of innovations such as ControLyo controlled nucleation and TDLAS (LyoFlux) that assist in developing challenging formulations from R&D to smaller production scale in a clinical setting.
The LyoConstellation S10 is a Line of Sight-enabled freeze-drying system for undertaking early stage development under aseptic and controlled conditions. This means product behaves in the same manner once it is ready for scale-up and eventually ready for commercialisation. The LyoConstellation S10 is designed, even when fully loaded, to hold 100mTorr vacuum and shelf temperatures of over +40°C enabling excellent sublimation rates with high moisture applications with no evidence of choked flow. Isolator and cleanroom integratable, the LyoConstellation S10 is capable of clean-in-place (CIP) and steam-in-place (SIP) for aseptic manufacturing.