New R&D Freeze Dryer Speeds Biopharmaceuticals to Market

The SP Hull LyoStar® 4.0 is now launched and exclusively available from Biopharma Group in the UK, Ireland and France.

The LyoStar 4.0 freeze dryer has been developed to enhance R&D and process development, including scale-up, to improve speed to market of biopharmaceutical products, representing a significant advancement in freeze dryer engineering.

As a pilot-scale freeze dryer, the LyoStar 4.0 offers superior shelf mapping, rapid shelf freezing, process accuracy and reliability. It also includes an innovative suite of Process Analytical Technology (PAT) tools supplementing SP's Line of Sight™ technologies. Additionally, an eco-friendly refrigerant gas is used to help comply with sustainability and environmental impact legislation.

"The LyoStar 4.0 has been specifically designed and manufactured with the needs of the research and cycle development scientist in mind. It offers design characteristics similar to our large production freeze dryers for faster delivery of a biopharmaceutical product to market," said Ian Whitehall, CMO at SP.

Ideal for rapid lyo cycle development, optimisation and scale-up, the LyoStar 4.0 incorporates the latest innovations in freeze drying technology to ensure precise process control and reliability. To enable this, a number of upgradeable PAT tools are included: LyoFlux® TDLAS sensors for vapour mass flow measurement, AutoMTM/SMART™ technology - a primary drying cycle optimisation tool, ControLyo® Nucleation Technology for accurate freezing point control, a 3D modelling package for computational fluid dynamics and process monitoring, plus Tempris® wireless sensors for real-time product temperature measurement.

The flexibility to scale-up or down is an important aspect in the process for developing pharmaceutical compounds. The LyoStar 4.0 also has the same 21 CFR Part 11 compatible software (optional) and efficient refrigeration technology as the LyoConstellation range. As a part of SP's Line of Sight approach, we overcome critical lyophilisation challenges during development, scale-up and manufacturing of biologicals, thus enabling greater regulatory compliance.

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