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

Project Information

FORMBECC

Grant agreement ID: 827367

DOI

10.3030/827367

Project closed

EC signature date 13 July 2018

Start date 1 August 2018

End date 31 January 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

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)

Reporting period: 2018-08-01 to 2019-01-31

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

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.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

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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