Poland
Manufacturer/ Producer
Ardigen Bioinformatics is a bioinformatics company from Cracow, Poland that combines biological data collection, analysis and interpretation with specialized computer software to provide services for the so-called Life Science and Healthcare organizations and companies. As the company claim, Ardigen is the bridge between life sciences and modern IT technologies that helps various scientific, medical and healthcare companies and organisations in achieving better results and reaching new milestones. The company was established in 2008 and at first was functioning as a bioinformatics department of Selvita company, which is one of the the biggest and most well-known Eastern-European medicine discovery oriented companies. After some time, Ardigen became an independent company with focus only on bioinformatics, although it must be said that it is still part of the renowned Selvita Capital Group. Ardigen is known not only on the Polish and European markets but also has seen a visible increase in popularity among American customers, especially companies and organisations from west coast of the United States.
Switzerland
The step from the laboratory to manufacturing for clinical trials is a major challenge. Simple hand movements in the laboratory often cannot be easily translated into process steps of industrial manufacturing. We are specialised in such scale ups. Contact us for an initial discussion! Analysis We prepare your laboratory data and compare it with the possible process parameters at the contract manufacturer. If data or optimisations are still missing. We develop the test plan for this. We carry out certain scale-up trials (non GMP) at our technical centre. We accompany specific trials (e.g. with your API) on your premises or those of a plant manufacturer. Models and simulation From the data, we generate the process models you need for scaling up. You will also need these models for the submission documents. We use the data to simulate different scale-up concepts. So if you later transfer from the special CDMO for clinical production to the CDMO for commercial production
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