Ballrechten-Dottingen, Germany, November 2018
Since 2000, the non-profit organisation Waisenmedizin e. V. Freiburg has been supporting patient-oriented developments in the area of neglected diseases, with a prevalence threshold in Europe of <5 cases / 10,000 citizens. Medical products to treat such “orphaned” diseases are called “orphan drugs”. With an “Orphan Designation”, the Legal Framework of the EU facilitates such developments.
A current project is the manufacture of a medical device for the treatment of cutaneous leishmaniasis – a “neglected tropical disease” which leads to facial disfigurement. Skin lesions are produced by the bites of female sand flies, which transmit the leishmania parasites when sucking blood.
To promote the healing of skin leishmaniasis wounds, Waisenmedizin e.V. has developed the LeiProtect® gel. The German Federal Institute for Drugs and Medicinal Products (BfArM) has meanwhile granted special approval for LeiProtect® according to §11 of the Medical Device Regulation (MPG). LeiProtect® is a gel which seals the lesion with a protective film.
The manufacture of the gel poses a technological challenge: When mixing the dry and liquid components of the gel by stirring, a high quantity of air is included in the mass. These air inclusions prevent the gel from sealing with a tight film after drying.
When using conventional mixing devices, a vacuum must be applied for degasification for 24 to 48 hours in order to prevent air inclusions. During this degasification process, however, one component volatizes, thus reducing the effectiveness of the gel.
With the support of YSTRAL GmbH, an equipment manufacturer located in Ballrechten-Dottingen near Freiburg with a strong focus on process-engineering solutions, a manufacturing process was developed which permits the production of LeiProtect® gel without the subsequent degasification process. Indeed, by using a specific powder wetting process under a brief vacuum, the inclusion of air is prevented from the very start. The cooperation initiated by the physician and researcher Professor K.-W. Stahl, who is responsible for this development, led to the generous donation by Ystral GmbH of the PiloTec process equipment required for LeiProtect® gel production.
The YSTRAL PiloTec is specifically designed for small batches (5-50 litres per batch). It is composed, among others, from the YSTRAL Conti-TDS-1 and an YSTRAL jetstream mixer, and meets the requirements for CE certification for the manufacture of medicinal products. The process equipment has meanwhile been installed in the GMP-certified pharmacy of the University Clinic Erlangen as a loan by Waisenmedizin e. V., and will permit the production of LeiProtect® in time for the next leishmaniasis skin wound outbreak, which peaks during the winter season in leishmania endemic MENA countries.