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

Informazioni relative al progetto

FORMBECC

ID dell’accordo di sovvenzione: 827367

DOI

10.3030/827367

Progetto chiuso

Data della firma CE 13 Luglio 2018

Data di avvio 1 Agosto 2018

Data di completamento 31 Gennaio 2019

Finanziato da

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Costo totale

€ 71 429,00

Contributo UE

€ 50 000,00

Coordinato da

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)

Periodo di rendicontazione: 2018-08-01 al 2019-01-31

Sintesi del contesto e degli obiettivi generali del progetto

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.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

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.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

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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