Small scale GMP production of parenterals

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 lyophilization development in relation to the small-scale manufacture of parenteral products. SP Scientific have a strong heritage in freeze-drying technology and offer a range of proprietary technological innovations such as ControLyo® controlled nucleation and TDLAS (LyoFlux®) which are proven to 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 commercialization. Offering a capacity of 9.8 ft2 (0.85 m2) and precise shelf temperature control from -55°C to +65°C, the LyoConstellation S10 is designed, even when fully loaded, to hold 100mTorr vacuum and shelf temperatures of over +40°C enabling unmatched 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.

The LyoConstellation S10 is powerfully equipped as standard to provide very high capacity, broaden equipment capability and expand design space. Configurable with the latest technologies including SMART™ cycle optimization technology, ControLyo® Ice Nucleation Technology and LyoFlux® TDLAS (Tunable Diode Laser Absorption Spectroscopy) for vapor mass flow measurement and inference of critical data such as batch product temperature and batch Kv (vial heat transfer coefficient), the LyoConstellation S10 is able to deliver an unmatched array of process analytical data. These technology options together with the LyoS™ software platform, for working in compliance with 21

CFR Part 11, are common to the full range of SP Scientific freeze dryers enabling the same technologies and equipment to be used for both R&D and production.

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