Most biotherapeutic products, particularly in liquid form, require refrigeration for most or all of their shelf-life. However, there is a need to develop products that can be stored and used outside the cold chain. In the increasingly patient-centric pharmaceutical industry there is a strong trend toward self-administered products, outside of the hospital setting. The ability to store the biotherapeutic product outside the cold chain, at least for the duration of the in-use period, has become increasingly desirable from both a patient convenience and compliance as well as competitive advantage perspective. In many cases, extended in-use stability outside of the cold chain is a required attribute for further development and commercialisation, as well as an avenue to protect market share via Life Cycle Management strategies. In addition to extending the in-use stability, there is also a significant unmet need of the distribution and storage of therapeutic drugs outside of the cold chain, and often at higher temperatures, particularly within developing territories.
However, achieving such thermostability is often very challenging using conventional formulation approaches. The Arestat™ technology has been proven across a broad range of proteins, peptides and vaccines to deliver significantly improved stability profiles leading to enhanced thermostability.
If you are interested in learning more please contact us.