Wednesday, July 27, 2022
MoonLake Immunotherapeutics AG, a clinical-stage biotechnology company focused on creating next-level therapies for inflammatory diseases, today announced that it has signed a Master Development Services Agreement with Vetter Pharma International GmbH (Vetter), a leading global contract development and manufacturing organization for fill and finish services, ranging from development support, including clinical manufacturing, through to commercial supply.
Under the agreement Vetter will be responsible for the aseptic filling of syringes with sonelokimab, and the subsequent assembly into an autoinjector combination device and packaging. Sonelokimab is MoonLake’s investigational Nanobody® designed to treat inflammatory disease by inhibiting the naturally occurring IL-17A/A, IL-17A/F, and IL-17F/F dimers that drive inflammation. In addition, sonelokimab is designed to directly target sites of inflammation and penetrate difficult-to-reach inflamed tissues.
Development studies associated with the manufacturing of sub-cutaneous sonelokimab for clinical trials and commercial volumes have been concluded, and technical engineering batches started in Q2 2022. The first clinical Good Manufacturing Practice batches are expected to be manufactured in Q4 2022 as a complementary, second supply point alongside the current source of drug product for clinical use.
Oliver Daltrop, Chief Technical Officer of MoonLake, said, “I am excited to work with such a high quality and reliable partner. With Vetter’s world-class support, we have further strengthened the supply chain for sonelokimab from drug filling through to finished product.”
Carsten Press, Senior Vice President Key Account Management, Supply Chain Management and Marketing at Vetter, added, “As an experienced service provider for the production of vital medications for patients in need, we look forward to partnering with MoonLake to bring its novel Nanobody sonelokimab from the development stage to commercial launch.”