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Funding project for researching and developing a GMP manufacturing process for tuberculostatics

Within the promotion of economic development and innovation by the Thüringer Aufbaubank the research and development project „Research in new synthesis cycles and development of a manufacturing process based on them in accordance with the internationally agreed rules of Good Manufacturing Practice (GMP) for the tuberculostatic benzothiazinone BTZ 043“ has been started. This project belongs to the field of specialisation Healthy Life and Health Care Management of the RIS3 Thuringia and concerns the key objective „In Thuringia leading solutions in analytics, diagnostics, monitoring and therapy for medical applications and for healthy nutrition shall be created.“

The Leibniz Institute for Natural Product Research and Infection Biology – Hans-Knöll-Institute (HKI) as well as the Munich Ludwig Maximilian University (LMU) are involved in this project as further key partners.

At the HKI Jena a new active pharmaceutical ingredient was filed for a patent application in 2006, and so was a chemical synthesis route in 2007. The substance of the family of benzothiazinones is labelled BTZ 043 and is applicable for fighting the tuberculosis pathogen due to its outstanding effectiveness (Science-Publication 2009, Thuringian Research Award 2009). On the grounds of the extraordinarily promising test data the substance could be brought into the preclinical development at an early stage. According to information provided by HKI Jena, the current preclinical tests in cooperation with the LMU Munich, Professor Michael Hölscher will be completed soon and the clinical phases for BTZ 043 shall commence. 

As the clinical studies are tests conducted on human beings with drugs containing active pharmaceutical ingredients, strict national and international regulations for the manufacture and quality control of the active pharmaceutical ingredient are statutory (EU-GMP guideline part 2 and ICH guidelines Q7, respectively, both paragraph 19), the compliance of which is mandatory and verified by various audits conducted by the authorities.

To validate the clinical studies the manufacturing process of BTZ 043 in compliance with GMP at HAPILA GmbH has to be developed in the corresponding batch sizes and the respective quantities of the active substance have to be manufactured. For this purpose, the guidelines of ICH (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use) applying to active pharmaceutical ingredients have to be met and the corresponding data have to be generated. Generally, when reaching the respective next level of the clinical phases, considerably more information for meeting the regulatory stipulations must be provided than in the preceding clinical phase.

The project is sponsored by the Free State of Thuringia with the number 2016 FE 0097, co-financed by means of the European Union within the framework of the European Fund for Regional Development (EFRE).