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Sublimation is the direct transformation of a solid to a gaseous state. For instance, at standard pressure and room temperature, solid carbon dioxide sublimes to gaseous carbon dioxide. The phase diagram depicts the conditions required for sublimation. This process occurs at the solid-gas phase boundary and is not observed above the triple point of the substance. The reverse of sublimation is called deposition, where a gaseous substance condenses directly into a solid. Sublimation and...
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Characterization of Freezing Processes in Drug Substance Bottles by Ice Core Sampling.

Sarah S Peláez1,2, Hanns-Christian Mahler1,2,3, Pau Rubirola Vila1

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Minimizing cryo-concentration during biological drug substance (DS) freezing is key for protein stability. A new ice core sampling method effectively measures cryo-concentration in frozen DS bottles, aiding process optimization.

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cryo-concentrationdrug substance bottlesfrozen storagelarge-scale freezingprocess characterization

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Area of Science:

  • Biopharmaceutical Manufacturing
  • Process Engineering
  • Protein Stability

Background:

  • Freezing biological drug substance (DS) is critical but can cause protein aggregation and particle formation due to cryo-concentration.
  • Macroscopic cryo-concentration is influenced by freezing rate, container type, size, fill level, and equipment.
  • Current methods for evaluating cryo-concentration are limited by product requirements and destructive sampling.

Purpose of the Study:

  • To develop a simple, scalable methodology for experimentally characterizing cryo-concentration in frozen DS bottles.
  • To identify a reliable indicator for cryo-concentration measurement.
  • To demonstrate the method's utility in comparing different freezing protocols.

Main Methods:

  • Development of a novel ice core sampling technique for frozen DS bottles using a surrogate solution.
  • Measurement of cryo-concentration via osmolality, histidine, and polysorbate 80 (PS80) concentrations.
  • Comparison of cryo-concentration in bottles subjected to different freezing temperatures (-80°C vs -40°C).

Main Results:

  • The axial ice core in the center of the frozen DS bottle was identified as indicative of cryo-concentration.
  • Osmolality proved to be a sensitive and reliable read-out for quantifying cryo-concentration.
  • Prolonged freezing stress times correlated with increased cryo-concentration in the axial center, as measured by osmolality.

Conclusions:

  • The developed ice core sampling method provides a simple and effective means to characterize cryo-concentration in frozen DS bottles at scale.
  • Osmolality is a suitable metric for assessing cryo-concentration and its impact on protein stability during freezing.
  • This methodology aids in understanding and optimizing freezing processes to minimize cryo-concentration and preserve drug substance quality.