Facilities

Stemmatters’ facility is located within the Guimarães Science and Technology Park (Avepark) and includes 300 m² of development laboratories and GMP-compliant suites. These facilities are designed to support the manufacturing of cell therapies and biological products in full compliance with the European Union Tissue and Cells Directives (EUTCD) and cGMP guidelines.

Our facilities include

11 cGMP-compliant cleanroom areas, designed for various stages of advanced manufacturing

4 Grade C / ISO 7 manufacturing rooms equipped with aseptic isolators (Grade A / ISO 5) operating under positive pressure

2 Grade D / ISO 8 rooms, including a support room and a storage area

Dedicated aseptic filling room, including semi-automatic equipment

Dedicated manufacturing room for cell expansion

cGMP lyophilisation unit

Pharmaceutical-grade CO2, compressed air, and LN2 network supplies

Environmental monitoring, and temperature, humidity and pressure monitoring

cGMP storage capabilities, accommodating room temperature, refrigerated, ultra-low freezing, and cryopreservation requirements

Advanced manufacturing

Our cleanrooms are fitted with state-of-the-art equipment, supporting cGMP manufacturing of biologicals (for example, blood-derived raw materials and medicinal products), as well as semi-automated manufacturing of cell therapies encompassing cell isolation and enrichment (e.g., fluorescence-activated cell sorting and magnetic-activated cell sorting), cell expansion (e.g., small and medium-scale bioreactors), cell downstream processing (e.g., counter-flow centrifugation).

Dedicated quality control facilities

Stemmatters has a quality control (QC)-dedicated room for activities related to the testing of raw materials, intermediate product(s), and finished product(s), as well as for activities addressing environmental monitoring of controlled environment rooms (CERs). The QC room is supported by a biology lab, fully equipped for the execution of cell-based experimental activities (such as cell growth and functional assays) and characterisation assays (e.g., flow cytometry, real-time PCR).

Compliance with BSL-2 GMO standards

Our manufacturing rooms and QC laboratories are authorised for handling Biosafety Level 2 (BSL-2) Genetically Modified Organisms (GMOs), in full compliance with European Directive 2009/41/EC.

At Stemmatters, we stay at the forefront of cGMP advancements, collaborating with our partners and suppliers to meet customers’ requirements with flexibility and efficiency.

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