Stabilizing and Protecting Solutions

Mode of action

  • SPS® are individual compositions of 5-8 excipients
  • All compounds are available in pharmaceutical grade and are regulatory established excipients

LEUKOCARE’s SPS® excipients and formulations stabilize and protect the three dimensional structure and functionality of proteins

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SPS® Stabilizing and Protecting Solutions

SPS® are individual compositions of 5-8 excipients applied as aqueous solutions and demonstrate the following characteristics:

  • Excipients listed in pharmacopoeias (USP, EP, JP)
  • Excipients in general listed as inactive ingredients by FDA
  • All excipients available in pharmaceutical grade
  • Formulations usually sugar and protein free, but fully compatible with bulking agents etc.
  • Formulations easily adaptable to specific biomolecules and needs

SPS® are successfully applied to molecules ranging from small peptides, large proteins and antibodies to viral antigens and live viruses.

The individual SPS® compositions can be adapted with regard to the specific excipients and their concentrations, pH, osmolality, other compounds (salt, bulking agents), etc.

Stabilization and protection by SPS® can be explained by the principles of water replacement and preferential exclusion. These result in protection against damage during manufacturing and terminal sterilization as well as extended shelf life.

SPS Mode of Action Stabilizing Solution
  • In dry formulation appropriately selected SPS® excipients replace water and build hydrogen bonds and other non-covalent interactions with the target protein.
  • Replacement of water by SPS® excipients prevents oxygen radical formation during increased temperature or irradiation.
  • SPS® excipients provide anti-oxidative effects.
  • SPS® formulations build a glassy state and an amorphous shell to protect the three dimensional structure e.g. to avoid unfolding or aggregation.
  • SPS® formulated biologics can be easily reconstituted.
SPS stabilize and protect the three dimensional structure of proteins and therefore, increase their stress resistance. This results in protection against damage during manufacturing and terminal sterilization as well as extended shelf life.
  • In liquid formulation appropriately selected SPS® excipients are purposely excluded.
  • Water-protein interactions are stronger than SPS®excipient-protein interactions resulting in a stabilizing hydration of the protein.
  • The hydration shell prevents interaction with co-solvents (preferential exclusion) resulting in a lower free energy and thus increased stability of the target protein.