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

Información del proyecto

FORMBECC

Identificador del acuerdo de subvención: 827367

DOI

10.3030/827367

Proyecto cerrado

Fecha de la firma de la CE 13 Julio 2018

Fecha de inicio 1 Agosto 2018

Fecha de finalización 31 Enero 2019

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

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)

Período documentado: 2018-08-01 hasta 2019-01-31

Resumen del contexto y de los objetivos generales del proyecto

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.

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

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.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

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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