Ziccum AB (publ) (‘Ziccum’) has today received readout results from the latest stage of an evaluation agreement study carried out with a leading pharmaceutical corporation (previously communicated on June 3, 2022) analyzing LaminarPace’s ability to dry four test substances. Data demonstrated excellent results on thermostability, positive results on particle appearance but significant loss of infectivity, requiring further development. The client has paused assessment of LaminarPaceTM on the current vaccine platform, but will consider the technology in regard to other vaccine platforms, where dry formulation could be a higher priority.
The study analyzed LaminarPace’s ability to dry four test formulations from one of the client’s vaccine platform technologies from liquid into dry powders that would remain active and thermostable. Data were gathered from three key metrics: its virus count (an important metric of thermostability), the powder’s infectivity (its capability for vaccination efficiency), and its particle distribution. Also, the samples were exposed to so-called ‘temperature excursions’, with extended storage at both 40 and 55 degree C.
The readouts reveal that the LaminarPaceTM drying provides a very clear positive effect on thermostability, where the LaminarPaceTM technology preserves the viral particle count on excellent levels after prolonged heated storage, even in the extreme 55 degree C temperature testing. However, for the infectivity measures, this stage of testing resulted in significant loss of infectivity units, which will need further development work.
Regarding particle appearance, the LaminarPaceTM drying has given impressive particle preservation in microscopy analysis of the samples exposed to heated storage, compared to how these elevated temperatures normally are detrimental to the vaccine particles.
The study shows good potential for the LaminarPaceTM technology in vaccine drying.
Considering the need for continued development, the partner company is planning to stay with liquid formulations for the platform at hand at the present time, but will assess further information on the LaminarPaceTM technology since there are other vaccine platforms where dry formulation could be a higher priority.
Ziccum CEO Ann Gidner: “We are delighted to see this clear confirmation of thermostability, where LaminarPace is a game-changer. The activity preservation needs to be improved in further development for this vaccine platform, and we are happy to have recently implemented improved methodology for better experimental plan design, to address this and take the development forward.”
“Both parties in this collaboration learnt significantly from this process, and we achieved encouraging results. Our team at Ziccum has grown in capabilities and confidence over the course of this project, and we are delighted to have a good dialogue with our partner.”