Learn more About

CONTRACT
MANUFACTURING

Stemmatters provides contract research, development and manufacturing services of biological and cell based products under the irisbiosciences brand.

REGULATORY
COMPLIANCE

Stemmatters is certified according to Standard EN ISO 9001, Quality management systems – Requirements, and Standard NP 4457, Research, Development and Innovation (RDI) management system requirements.

All critical processes are validated and all critical equipment and utilities qualified as described in our Validation Master Plan. Stemmatters Quality System is in conformity with the European Good Manufacturing Practice (GMP) and ICH Q7 guidelines.
Company clean rooms are authorized as Tissue Establishment (2004/23/EC Directive) and certification is undergoing for manufacturing of medicinal products.

Stemmatters is registered as SME with the European Medicines Agency (EMA).

INFRASTRUCTURE

The company operates Biosafety Level-2 (BSL-2), Research and Development (R&D)and Quality Control (QC) laboratories for development of medical devices and biological products.

Our clean room facility comprises qualified controlled environment rooms (CERs), or clean rooms, and material pass throughs. CERs consist of 8 cGMP cleanroom areas.
CERs are designed to maximize environmental quality, allow manufacturing of sterile products and are compliant with requirements of the European Union Tissue and Cells Directives (EUTCD) and the guidelines for cGMP.