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The SP Line of Sight™ Approach

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Line of Sight is a data rich set of lyophilization technologies and process analytical technology (PAT) tools designed to overcome critical lyophilization challenges during development, scale up and manufacturing of biologic products. It also enables continuous process monitoring and improvement as expected by regulatory agencies. Each element of the Line of Sight suite helps lyophilization scientists to better understand different facets of the freeze-drying process. By using Line of Sight technologies across all the different products, SP uniquely enables development scientists to create new freeze-drying cycles and transfer their products and processes quickly and confidently from one scale to the next, and even from one facility to another. Should any unexpected deviation in a production cycle occur, Line of Sight technology enables a detailed analysis of the process, allowing scientists to decide whether the batch can be safely released, potentially saving many millions of dollars.

Development and Scale Up Using Scalable Technologies and Process Analytical Technology (PAT) Tools:

  • Freeze-Drying Microscope - Allows observation of the sample structure during drying and heating so the exact point of collapse can be determined
  • LyoStar™ 3 Freeze Dryer - The industry standard for cycle development and cycle optimization activities
  • LyoConstellation™ Freeze Dryers - Family of larger production freeze dryers that not only perform cycle pre-formulation through to full-scale production and freeze-dried product analysis development but offer fully aseptic operation
  • Freeze Drying Contract Services - A collaborative service for a range of lyophilization contract research and development services, from pre-formulation through to full-scale production and freeze-dried product analysis

Line of Sight™ Process Analytical Technology (PAT) Tools:

  • ControLyo® Nucleation Technology - Precise control of the freezing point
  • AutoMTM/SMART™ Freeze Dryer Technology - Primary drying cycle optimization tool for in-depth product information
  • LyoFlux® TDLAS Sensors - Accurate measurement of vapor mass flow for calculation of critical product attributes
  • Tempris® Wireless Sensors - Real-time accurate and reliable product temperature measurement

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