Characterization of Freezing Processes in Drug Substance Bottles by Ice Core Sampling

Key facts in this white paper:

  • Introduction of a novel “Ice Core” sampling technique for Drug Substance Bottles.
  • Freezing of biological drug substance (DS) is a critical unit operation that may impact product quality, potentially leading to protein aggregation and sub-visible particle formation.
  • Cryo-concentration has been identified as a critical parameter to impact protein stability during freezing and should therefore be minimized.