Need for Arecor's Arestat™ stabilisation technologies

Proteins are an increasingly important tool in medical and diagnostic applications. However, many proteins are sensitive to heat and/or the ionising radiation that is typically used in sterilisation. There is a growing need for technologies to improve the stability of proteins in storage and to increase flexibility in their production and use.

Proteins are important commercially and in society

Many drugs (eg insulin, vaccines) and industrial components (eg enzymes) are proteins, which require sterilisation and/or long-term storage.

Retention of activity of proteins is problematic

Water dissociation products are damaging to proteins. These accumulate during long-term storage or gamma radiation.
Ionising radiation is often used to sterilise medical devices but, typically, it will destroy the function of a protein.
The pH of the protein in solution is important for protein stabilisation but, in practice, optimisation of pH alone is often not effective.

Protein stabilisation can be problematic

Several approaches are being taken to stabilise proteins - they can have significant disadvantages:

Freeze-drying is costly, especially if sterility is required during production. It also limits final presentation to a dry powder format.
Covalent modification of the protein creates a new chemical entity, which can have long and unpredictable regulatory hurdles.
Encapsulation technologies (eg into glasses) require substantial changes to manufacturing practices and additional regulatory hurdles.
The use of excipients that have no safe history of use in man can have additional regulatory hurdles.

Last updated: 13 June 2008