New Pilot-Scale Lyophilizer Aids Biologics Drug Development

SP Scientific Products (SP) launched its SP Hull LyoStar 4.0 R&D and process development freeze dryer is based on a full-scale production freeze dryer to support rapid lyophilization cycle development, optimization, and scale-up. The pilot-scale lyophilizer offers shelf mapping and rapid shelf freezing, as well as a suite of process analytical technology (PAT) tools. In addition, the equipment uses a more eco-friendly refrigerant gas that reduces the carbon footprint involved in lyophilization.

PAT tools used by the equipment include LyoFlux TDLAS sensors for vapor mass flow measurement; AutoM/SMART Freeze Dryer Technology, a primary drying cycle optimization tool; ControLyo Nucleation Technology, which gives pinpoint control of freezing point; a three-dimensional modeling package for computational fluid dynamics and process monitoring; and Tempris wireless sensors for real-time product temperature measurement.

The equipment was designed to both scale up to production and down to R&D as part of SP’s Line of Sight approach across all its products. The LyoStar 4.0 scales up to the SP Hull LyoConstellation line of production lyophilizers and uses the same efficient refrigeration technology. Line of Sight also enables continuous process monitoring and improvement, in line with Pharma 4.0.