The German health authorities have granted LTS’ whole-owned affiliate partner Innovative Injektions-Systeme (IIS) its first permit to manufacture transdermal microarrays and microarray-patches in Europe.
IIS has extended an existing permit for the manufacture of small-volume sterile pharmaceuticals to include transdermal microarrays and microarray-patches for transdermal delivery of large molecules.
Inspection by the German health authorities approved IIS processes in manufacturing laboratories, cleanroom manufacturing and microbiology, including quality control (QC) and quality assurance (QA).
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.
Managing director of IIS Dr Stefan Henke said: “We are very encouraged to be the first 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.”