LaminarPace System: a breakthrough technology for dry-formulation of sensitive pharmaceuticals at room temperature enhancing their stability beyond the cold chain

Informations projet

FORMBECC

N° de convention de subvention: 827367

DOI

10.3030/827367

Projet clôturé

Date de signature de la CE 13 Juillet 2018

Date de début 1 Août 2018

Date de fin 31 Janvier 2019

Financé au titre de

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coût total

€ 71 429,00

Contribution de l’UE

€ 50 000,00

Coordonné par

ZICCUM AB
Sweden

Periodic Reporting for period 1 - FORMBECC (LaminarPace System: a breakthrough technology for dry-formulation of sensitive pharmaceuticals at room temperature enhancing their stability beyond the cold chain)

Période du rapport: 2018-08-01 au 2019-01-31

Résumé du contexte et des objectifs généraux du projet

The phase 1 project was aimed at performing the feasibility study for the commercialization of LaminarPace, a new method of spray drying of biologicals in room temperature. As opposed to current dry formulations that involve extreme temperatures (+80 °C and -80°C) our innovation enables to dry vaccines using natural forces, thus reducing energy requirements and improving efficiency. Additionally, our spray drying process produces a formulation that is significantly less sensitive to temperature-induced degrading, opening a new state of the art on the vaccine market. Our plan on this phase I project was to elaborate a feasibility plan (including technical and market feasibility) and a business plan for our innovation.

Travail effectué depuis le début du projet jusqu’à la fin de la période considérée dans le rapport et principaux résultats atteints jusqu’à présent

As a result of this project we have elaborated a feasibility plan and a business plan. We have spotted the necessary steps for the technical feasibility of our spray dried process and have developed a market feasibility research. A significant result of this meetings, explorations, surveys and contacts has been the realization that our market niche. Ziccum AB was originally intended to be commercialized as a device that would be sold to pharmaceutical companies but, after the discussions, we have concluded that our appropriate niche is the vaccine manufacturing where the potential to produce thermostable vaccines would be ground-breaking.

Progrès au-delà de l’état des connaissances et impact potentiel prévu (y compris l’impact socio-économique et les conséquences sociétales plus larges du projet jusqu’à présent)

We have launched an internal project to dry-formulate adenoviruses. Having successfully completed this project, Ziccum has submitted a patent application on this dry, thermostable formulation and intents to enter the vaccine manufacturing market.
Our current system works with small amounts of substance at a time and is capable of drying up to 1 g of substance per day. With the technical and application requirements fully defined, and the business plan established, the commercialisation of LaminarPace depends now on successful demonstration of the process as an integrated part of production lines in the vaccine industry. If the cold chain requirements get eliminated from the equation we believe the impact of our innovation could make a significant contribution in reaching a 100% vaccination coverage set by the WHO.

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