Company premises include a GMP facility with clean rooms (Classes A, C and D) and the company operates 250 m2 of fully equipped BSL Level 2, R&D, Analytical and QC laboratories for development of medical devices and tissue engineering products.
irisbiosciences provides 3D cell culture products , as well as contract research and manufacturing services in cell based essays and cell based products.
mimsys® for 3D Cell culture
mimsys® G is a xeno-free and non-immunogenic hydrogel, easy to handle, for cell encapsulation in 3D experiments in vitro or in vivo. mimsys® G is nutrient permeable and allows long term 3D cell culture, at least 21 days of proliferation and survival. The transparency of mimsys® G hydrogel make it suitable for established laboratorial cell assays, such as cell differentiation, microscopy evaluations, viability protocols and histological procedures. Protocol handbook is available upon request.
Human Mesenchymal Stem Cells
High quality and high purity mesenchymal stem cells are obtained from human adipose tissue. These cells can be applied in a broad range of basic and applied research contexts. Tissue processing, cell isolation and cryopreservation are performed under Good Manufacturing Practices (cGMP), using xeno-free and GMP reagents. Cells have very low levels of manipulation which minimizes genomic instability. Frozen vials are provided with indication of donor age, gender, ethnicity, Body Mass Index (BMI) and anatomical harvesting location. Protocol handbook is available upon request.
irisbiosciences provides contract research services on medical device and advanced therapy medicinal products, by encompassing experimental development, in vitro performance assessment and in vivo testing. Our skill set includes strong competence in biomaterials’ development and cell culturing technologies, and extensive knowledge and experience in tissue engineering and regenerative medicine.
- Biomaterials development and testing;
- Cell based assays development and validation;
- Cell isolation and cell manipulation protocol development;
- Development and testing of cell based products.
Contract Manufacturing Services :
irisbiosciences provides a wide range of cGMP services concerning human tissue, cells and related products, including tissue processing, manufacturing of cell-based products, as well as cell manufacturing and banking.
The facility comprises 250 m2 of qualified controlled environment rooms (CERs), or clean rooms, and material pass-throughs. The CERs are designed to maximize environmental quality, allow the manufacturing of sterile products and are compliant with all the requirements of the European Union Tissue and Cells Directives (EUTCD) and the guidelines for cGMP.To insure the highest levels of quality and regulatory compliance, we have implemented and follow a complete Quality System in conformity with EU-GMP Guide/ICH Q7 and ISO 9001:2008.
irisbiosciences performs a comprehensive range of analytical testing to ensure product quality and demonstrate the control of viable and non-viable particles, in all irisbiosciences CERs associated with the aseptic preparation process. Quality control tests include LAL test for bacterial endotoxin quantification; mycoplasma detection by conventional PCR, and microbial contaminants detection / Sterility tests. For detection of microbial contaminants, irisbiosciences is equipped with Bact/ALERT Microbial Detection System requirements.
Our Facilities/Equipment description:
- 6 cGMP compliant cleanroom areas;
- 3 Grade C/ISO 7 manufacturing rooms fitted with aseptic Isolators with positive pressure;
- 1 Grade D/ISO 8 support room and cryostorage room;
- 2 HVAC systems for continuity of processing;
- Dedicated clean room and facility monitoring system;
- Dedicated manufacturing room for cell expansion;
- O2 and CO2 controlled incubation.