Arestat-T™ technology is based upon a formulation ‘tool kit’ providing a number of specific innovations which address the principal heat and concentration-related degradation pathways of proteins, vaccines and other biologicals. Arestat-T™ is used to produce bespoke stabilized formulations of biologicals both for therapeutic (hormones, antibodies, enzymes and vaccines) and diagnostic (kits, assays, strips and sensors) applications. Arestat-T™ technology is designed to facilitate the development of biologicals through stabilization, enabling them to realize their therapeutic or diagnostic potential.

Arestat-T™ can achieve long shelf-stability of biologics previously considered unstable in aqueous phase. Dry powders of hormones, recombinant proteins, enzymes, vaccines and macromolecules can readily be transformed to stable liquids which can be stored at elevated temperatures making possible the elimination of the cold-chain with the added benefits of reduced cost of production and transportation. The technology also allows proteins to be formulated at high concentrations heretofore made difficult due to unacceptable levels of aggregation.

Arestat-T™ is an enabling technology creating opportunities for therapeutic and diagnostic candidates whose development programmes have been hindered by critical stability issues which cannot be resolved by conventional approaches. Candidates such as single chain antibodies, chimeric proteins or proteins requiring encapsulation can be progressed through to a full development programme. The technology can also be applied in the manufacture of depot formulations intended to extend the in vivo half-life of therapeutic proteins through encapsulation either by polymers or liposomes. Many of the encapsulation technologies require stabilization of the protein at body temperatures or at a high concentration prior to ‘packing’ or ‘capturing’. Arestat-T™ can address this need.

Formulations produced by the application of Arestat-T™ buffers and excipients can be stored as liquids (e.g. in pre-filled syringes, pens, cartridges and vials), or dry powders or in another solid phase (needle-free devices, patches and depots).

Arestat-T™ technology is based on tools which address both chemical and physical instability of proteins. These novel tools can be used in combination with conventional formulation science. The physical stability of proteins is undermined by a number of reversible reactions which take place at equilibrium between the protein and its surrounding environment. Examples of such reversible reactions are the trafficking of protons or metal ions within the structure of proteins. The consequence of these reactions is a continuous fluctuation of the charge distribution in proteins. Such charge fluctuation allows proteins to explore ‘extreme states’ during storage which can initiate a series of conformational changes leading to instability.

A unique feature of Arestat-T™ is the use of conventional buffering species in an unconventional manner. Another feature particular to metal-containing proteins is the inclusion of excipients which help to maintain an optimal balance between metal ions and the protein molecules. When these and other proprietary tools are applied together they minimize the rate of a number of processes, such as chemical modifications, protein-protein interactions or fluctuation of the tertiary structure, which lead to protein degradation. Considerable experimental validation is required to ensure that the appropriate tools and excipients addressing the relevant degradation pathways are applied in a complementary and additive way.

Arestat-T™ is protected by a number of published and filed patents.