MOLOGEN receives expanded manufacturing authorisation for MIDGE-based active substances

21-Jan-2009 - Germany

MOLOGEN AG has received a significantly expanded manufacturing authorisation for its MIDGE®-based DNA active substances. After detailed inspections, the responsible authorities have confirmed that the production and quality of the active substances meets the requirements of the German Medicinal Products Act (AMG) and the GMP guidelines. The manufacturing authorisation is no longer linked to individual active substances, but applies generally to the MIDGE® production process.

New active substances must merely be reported to the authorities. A separate, very time-intensive application for individual active substances is no longer required. The active substances which are produced for clinical trial products may be used in clinical studies up to and including Phase II.

The manufacturing authorisation marks the successful completion of process optimisations with the objective of being able to produce sufficient quantities of DNA active substances for clinical studies in the required quality itself.

The production process for dSLIM®-based active substances as they are currently being used in the clinical trial Phase I with MGN1703 was also inspected in detail in the course of the inspection process. Here as well, compliance with the AMG and the GMP guidelines in production and quality was confirmed.

''We have attained an important goal with the granting of the expanded manufacturing authorisation. We can now ourselves produce the DNA active substances that are required for our clinical development programs in the required quality and amounts'', Dr. Matthias Schroff, CEO of MOLOGEN AG, explained.

https://www.bionity.com/en/news/93910/mologen-receives-expanded-manufacturing-authorisation-for-midge-based-active-substances.html