Stemmatters offers cost-effective development and manufacturing solutions to developers of biological and cellular therapeutics. We have particular domain knowledge in combination products for regenerative medicine applications, biomaterials, and exosomes, but also work with cellular immunotherapies and other ATMPs. Our flexible approach enables us to work around your timelines and to your specification, integrating seamlessly with your own development programme to bring value to your assets. Our core capabilities include: - Translation of non-GMP protocols into a fully scalable, reproducible and validated GMP-compliant process - Cost of goods (COGs) optimisation - Design, development, implementation and validation of single-use, closed-system biomanufacturing processes and analytical quality control (QC) methods - Establishment of master and working cell banks - Fill and finish operations up to 50L, including semi-automatic operations up to 50mL - GMP storage at various temperatures: room temperature, refrigerated, ultra-low freezing and cryopreservation Contract Manufacturing Stemmatters offers manufacturing services for blood-derived products, cell and tissue products, cell-based ATMPs, and biopharmaceuticals. The focus and extent of the development, manufacturing and quality control services is agreed in specific technical and quality agreements. Quality and Compliance To insure the highest levels of quality and regulatory compliance, Stemmatters implements and follows a complete Quality Management System (QMS) in conformance with EU-GMP Guide/ICH Q7 guidelines. We offer professional quality management services to our clients and have a proven track record with competent authorities (DGS and INFARMED). Facilities Our facility comprises 300 m2 of qualified controlled environment rooms (CERs), 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. Partnering Stemmatters currently engages in strategic co-development partnerships in order to streamline the translation of innovative therapeutic products and maximise return on investment. As your partner, Stemmatters provides cost-effective solutions in development and GMP-compliant manufacturing of your cell therapies or biological products.