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Company

Stemmatters operates as a contract development and manufacturing organisation (CDMO) providing cost-effective solutions for early-stage regenerative medicine developers.

About Us

Stemmatters is a Portuguese contract development and manufacturing organisation operating in cell-based, tissue and blood-derived therapeutic products.

Created as a spin-off from academia (University of Minho, Portugal), Stemmatters holds over a decade of experience developing both proprietary assets and those of our external partners.

Stemmatters provides bespoke product, process and analytical development services tailored to each of our client’s needs. We have a strong track record of seamless technology transfer procedures, assuring the ability to implement and validate optimised manufacturing solutions in-house. Stemmatters’ track-record is demonstrated by successful multiple site audits from business partners and authorizations by competent authorities.

Stemmatters’ innovation offering is sustained by an innovative biomaterial product platform supporting formulation of combination products for multiple indications (please see mimsys® platform).

Based in the Braga district, just north of Porto, our location affords convenient access to Porto International Airport (OPO), which services flights throughout Europe and across the Atlantic. We are also closely connected to local and national networks of research and development centres as well as clinical facilities.

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Advisors

Partners

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Capabilities & Facilities

Stemmatters offers a full range of development and manufacturing services to stakeholders engaged in translation and clinical development of diverse range of biopharmaceutical and cell-based products, within the regenerative medicine field.

We provide diligent and reliable services to develop new products and manufacturing processes. Our flexible approach enables us to meet your specifications within the pre-defined timelines, thus integrating seamless coordination with development programme(s). Our central objective is to ensure the success of each customer, protecting quality specifications while minimizing costs.

Our core capabilities include:

  • Formulation development
  • Analytical development
  • Cost of goods (COGs) optimization
  • Process scale-up and optimization
  • Aseptic fill and finish
  • Quality assurance and control
  • Establishment of master and working cell banks
  • Translation of protocols into validated GMP-compliant processes

 

Stemmatters’ facilities comprise 300 m2 of qualified controlled environment rooms (CERs) designed to maximize environmental quality and allow the manufacturing of biological products compliant with all the requirements of the European Union Tissue and Cells Directives (EUTCD) and cGMP guidelines.

  • 11 cGMP compliant cleanroom areas
  • 4 Grade C / ISO 7 manufacturing rooms fitted with aseptic Isolators (Grade A / ISO 5) with positive pressure
  • 2 Grade D / ISO 8 rooms: support and storage room
  • Dedicated room for aseptic filling, including semi-automatic equipment
  • Dedicated manufacturing room for cell expansion
  • cGMP lyophilisation unit
  • Pharmaceutical-grade CO2, compressed air, and LN2 network supplies
  • Environmental monitoring: particulates and viable counts
  • Temperature, humidity and pressure monitoring
  • cGMP storage capacity at room temperature, refrigerated, ultra-low freezing and cryopreservation temperatures 
Quality & Compliance

Stemmatters has a deep commitment to quality. We maintain stringent in-house quality policies and seek continuously opportunities to improve our practices.

Stemmatters established a Management System that is certified and maintained in accordance with regulatory requirements of ISO 9001:2015, Quality management systems. Certification by TUV Rheinland focuses on our core-activities, namely, Research, development and manufacturing of raw materials, medical devices, biologicals and cell-based medicinal products.

Our Quality Policy supports sustained growth through development and manufacturing of a variety of products, including raw materials and medicinal products. Through continuous improvement, Stemmatters aims to consistently satisfy the needs and expectations of its customers and interested parties, in accordance with applicable requirements. Stemmatters’ medicinal products follow the current guidelines for Good Manufacturing Practices, through all lifecycle stages.

Stemmatters follows the principles and rules of good manufacturing practices for medicinal products for human and veterinary use, as detailed in “Eudralex Volume 4: The rules governing medicinal products in the European Union”.

  • Our clean rooms are qualified for the manufacture of sterile medicinal products
  • All critical processes are validated, and all critical equipment and utilities are qualified as described in our Validation Master Plan
  • Our Quality Management System is in conformity with the EU Guidelines to Good Manufacturing Practice (GMP) and ICH Q7 guidelines. Stemmatters holds a GMP certification and is a manufacturer registered in the database EudraGMDP from the European Medicines Agency (EMA).
Project Management

Project management is critical for successfully delivering the right results on time and within budget.  

Stemmatters has well-established internal management procedures to effectively and efficiently conduct projects internally, extracting maximum benefit from resources and capabilities while mitigating risks.

We provide a communicative and transparent project management style, ensuring sponsors’ full visibility of project status.

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Stemmatters adopts a practical and flexible approach to partnering. Every opportunity is addressed case-by-case, providing a granular and customized solution to the needs of our partners.

By partnering with Stemmatters you can also have access to our extensive network of scientific and clinical collaborators, who together represent a substantial collective source to receive technical advice and support, access clinicians, patients and starting materials.

Projects

Stemmatters is involved in numerous research and development projects funded by both Portuguese and EU grants. List of most relevant projects include:

  • “NOAHs-ARK - Novel advanced encapsulation system for delivery and protection of next-generation cell-based therapies”, European Horizon 2020 project (H2020-INNOSUP-2020-02-953284379)
  • “STRENGTHSTEM - Strengthening competitiveness of Stemmatters in international markets”, National project (NORTE-02-0752-FEDER-071300)  
  • “EXCELL - Setting a new standard in human Platelet Lysate products to excel clinical cell manufacturing”. National project (Eurostars E!113731, NORTE-01-0247-FEDER-047352)
  • “SENTINEL – Novel injectable biosensor for continuous remote monitoring of cancer patients at high-risk of relapse”, National project (UTAustin- Portugal, NORTE- 01-0247-FEDER-045914)
  • “EXCA-BIOTA - EXpansão e CApacitação industrial para fabrico de produto BIOlógico e Terapias Avançadas”, National project (NORTE-02-0853-FEDER-044326)
  • “NeuroStimSpinal - A step forward to spinal cord injury repair using innovative stimulated nanoengineered scaffolds”, European Horizon 2020 project (H2020-EU.1.2.1. - 829060)
  • Mimsys - Consolidação da plataforma de desenvolvimento de produto para aplicação médica e biomédica (Consolidation of product development platform for medical and biomedical applications) (NORTE-06-3559-FSE-000006)
  • “CVMar+i - Inovação industrial através de colaborações específicas entre empresas e centros de investigação no contexto de valorização biotecnológica marinha", Interreg project (0302_CVMAR_I_1_P)
  • “NeuroGraft - Development of functionalised cell seeded bio-artificial organ for transplantation in nerve repair”, European FP7 project (HEALTH-F4-2012-304936)
  • “Find and Bind - Mastering sweet cell-instructive biosystems by copycat nano-interaction of cells with natural surfaces for biotechnological applications”, European FP7 Small Collaborative Project (FP7-NMP-229292)
  • “CytoNanoHeal - Engineered nanotools for advanced cell therapies”, European project (ERA-NET EuroNanoMed-II)
  • “ARTICULATE - Development of new products and regenerative therapies for the treatment of articular pathologies”, National project (QREN-13/SI/2011-23189)