The German health authorities have granted „IIS Innovative Injektions-Systeme GmbH & Co. KG („IIS“) a wholly owned affiliate of LTS Lohmann Therapie-Systeme AG („LTS“) the 1st permit to manufacture transdermal microarrays / microarray-patches in Europe.
IIS successfully extended its already existing permit for the manufacture of small volume, sterile pharmaceuticals to include the manufacture of transdermal microarrays / microarray-patches. IIS develops microarray patches for transdermal delivery of large molecules.
The inspection by the German health authorities approved IIS processes in manufacturing laboratories, clean room manufacturing, microbiology including quality control and quality assurance. Aside from the IIS processes and facilities, the documentation of IIS processes was a particular focus of the inspection. As IIS pioneers the manufacture microarrays for transdermal delivery the health authorities placed a particular emphasis on safety.
“We are very encouraged to be the 1st pharmaceutical manufacturer with a manufacturing license for microarray patches in Europe. IIS has accomplished an essential strategic milestone. The next key step will be the manufacturing of transdermal microarray samples for clinical studies in human.” commented Dr. Stefan Henke, managing director of IIS.