Cessatech provides positive news regarding shelf life of CT001
- The ongoing stability studies of CT001 have provided confidence in achieving a shelf life of more than two years at controlled room temperature.
- The final clinical study 0202 can now be done with CT001 at room-temperature.
Based on ongoing stability studies of CT001 Cessatech A/S is announcing, that CT001 has been shown to be stable over a prolonged period of time and is now estimated to have a shelf-life of more than two years at controlled room temperature. This will greatly benefit the future supply chain management and will be a major advantage for the hospitals and clinics storing and working with CT001. The final anticipated market shelf-life will most likely be even longer and based on the outcome from stability studies of upcoming process validation batches.
Comment from Martin Juhl, CSO, Head of CMC & Device, Cessatech
The new stability data is a big development milestone for Cessatech towards developing an easy-to-use drug-device combination, which is estimated to be able to achieve a minimum of two years of shelf-life at room temperature. An update of analytical methods and a thorough assessment of all stability data, such as Sterility, Assay, Single Impurity, and Total Impurities, fully supports the estimated shelf-life of CT001. This achievement could only be done by a huge team effort between Cessatech and our collaborating partners.
Comment from Jes Trygved, CEO, Cessatech
We are now one step closer to complete our mission of bringing innovative new medicines to children - and the importance of CT001 at room-temperature should not be underestimated, both in terms of costs, handling, storage and easy to use at hospitals and clinics. The ongoing and previous clinical trials have been conducted with CT001 at cold-storage, but the final clinical study 0202 can now be done with CT001 at room-temperature. We continue the good work with our collaboration partners and thanks to a great effort by the team.