StemcellX

Developing our R&D Facilities

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Our team have recently moved to our brand-new R&D facilities in Szeged. The new GMP cell-production facility will fuel our growth and allow us to create a pipeline for developing more innovative treatments in the near future.

 

Importantly, our facilities now contain all necessary suits for handling and preparation of stem cell products that meet EU standards: The cleanroom where stem cell source materials are prepared for further processing possesses the EU GMP Grade B, US ISO 14644-1 and ISO 14689 Grade ISO5 standards. Our stem cell isolation and quality laboratories comply with stringent GLP principles. Depending on the type of work performed, our R&D laboratories also meet the required standards, including GLP where appropriate.

 

Additionally, the facility is part of a local Biotech Cluster: inside our building is Deltabio which provides cutting edge molecular diagnostics services for us and Enterprise Group which provides business solutions and IT support for the Biotech Market. More widely within the cluster, we can find The University of Szeged, BRC, The Bay Zoltán Institute and a site for Charles River Laboratories and a number of small biotech spinoffs. We’re excited about the possibilities of collaborations and knowledge transfer with such a wide range of startups and global leaders in the biotech space.

 

Transitioning to our first custom-built production facility increases the speed at which obtaining regulatory approval is possible, for our revolutionary stem cell therapies for dogs and further innovative products, yet to be announced.

We're excited about what this facility will unlock in our production and R&D capabilities.

The broad range of quality control laboratories includes a BSL2/3 pathogen diagnostic laboratory and a next-generation-sequencing-based diagnostic laboratory, this allows us to reach a speed and quality of production previously not available.

Lajos Haracska
CSO

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