Company
Stemmatters operates as a contract development and manufacturing organisation (CDMO) providing cost-effective solutions for early-stage regenerative medicine developers.
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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Rui A. Sousa
- CEng, MBA, PhD – CEO and Chairman
Co-founder and CEO since 2011, Rui is a hands-on entrepreneur with a track record in life sciences and medical devices. He has been pivotal for the creation and strategic management of the company, and the top responsible person for deploying business and operations of the company. Rui brings in technical, business, managerial and leadership experience from multiple innovation and technology projects.
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Vitor Dinis
- Board Member & Chief Financial Officer
Vitor is a co-founder, Partner and CFO of Pathena. He serves as a Board Member of several of Pathena's portfolio companies. Vitor started his career at Arthur Andersen in 1997 in the finance, accounting and controllership areas. In 2002 he joined Deloitte as a Manager. In 2003 he assumed the position of CFO at Enabler, a €30M systems integrator firm focused on Oracle retail implementations.
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Miguel Botto
- Board Member
Miguel has a long track record of investment selection and board membership and has been in charge of several reference VC and PE investments in the Portuguese market. Before that, he worked as CFO and Member of the Board in a company listed on the Lisbon Stock Exchange. At present, he is Director of Portugal Ventures’ Life Sciences & Med Tech business unit.
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David A. Learmonth
- BSc, PhD – CTO
Holds a Ph.D from the University of Strathclyde (Scotland) in medicinal chemistry. Experienced scientist and manager within the pharmaceutical/biotechnology sectors, contributing to the pre-clinical/clinical development of 15 molecules, including 2 approved drugs. Inventor of several hundred international patents on novel therapeutic substances, biomaterials, processes, formulations, administration regimes and medical applications. Overall responsible for Stemmatters’ research and discovery, development and translation of biomaterial-based medical devices.
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Fernando F. Martins
- Pharm. D - Qualified Person
Holds a degree in Pharmaceutical Sciences by the Faculty of Pharmacy, University of Oporto. Has 7 years of experience in hospital pharmacy and 12 years in the pharmaceutical industry. Throughout his career, held various positions in the field of Site Management and Quality Assurance, and completed a specialization in the pharmaceutical industry by the Portuguese Order of Pharmacists in 2014, becoming an EU certified Qualified Person.
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Luís E. Conceição
- PhD - Management System Director
Responsible for the Quality Management System / Quality Assurance at Stemmatters. Has a degree (2002) and a PhD (2009) in Biology and a Postgraduate degree (MBA) in Integrated Management Systems of Quality, Environment, Safety and Social Responsibility (2015). Additional skills include audit training (2016; Lead Auditor training – ABNT NBR ISO 19011:2012) and basic metrology (2019).
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Tiago R. Veloso
- BSc, PhD - RDI Director
Graduated in Applied Biology from the University of Minho (Portugal) and gained his PhD in Life Sciences from Lausanne University (Switzerland). Has carried out biomedical research for 10 years across Europe in the fields of host-pathogen interaction, platelet and vascular biology, vascular grafts and cartilage repair. Responsible for R&D activities and pre-clinical development of mimsys®. Expert in animal experimentation.
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Pedro M. Costa
- BSc, PhD – Senior Scientist
Graduated in Biochemistry from the University of Coimbra (Portugal) and later with a PhD in Biochemistry from the University of Coimbra (Portugal) in cooperation with Columbia University (NY, USA). Over 6 years of experience in biomedical research, with focus on nanocarrier development and functionalization for therapeutic applications in human disease. Experienced in primary cell and stem cell isolation/culture, cell-based assays, genome editing, animal surgery and laboratory sustainability practices.
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Flávia Sousa
- BSc, PhD – Senior Scientist
Gratuated in Pharmaceutical Sciences from IUCS (Portugal) and later with a PhD in Biomedical Sciences from ICBAS, University of Porto in cooperation with I3S (Porto, Portugal), Aalborg University (Aalborg, Denmark) and Northeastern University (Boston, USA). After PhD studies, she did a postdoc at Imperial College London in biomedical research with focus on nanocarriers and hydrogels development for therapeutic applications. Experienced in drug delivery systems, cell-based assays and animal experimentation (PK and PD studies).
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Elsa S. Moreira
- BSc - Manufacturing Manager
Holds a degree in Biochemistry from Beira Interior University. Worked in the immunohemotherapy lab at IPO Porto and in the London Cord Blood Bank. Expertise in processing, characterization, cryopreservation and storage of stem cells. Broad knowledge in planning and implementation of contract manufacturing services for cell-based products and biologics. Experience in audits performed by DGS, INFARMED and clients. Currently attending the Master's course in Molecular Medicine and Oncology at Porto University.
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Cláudia D. Alves
- BSc, MSc - Manufacturing Assistant
Holds a degree in Biomedical Engineering and a Master's degree in Biomedical Technology from the Polytechnic Institute of Bragança. Internship in Novavet® acquiring expertise in medical devices. Joined Stemmatters in September 2017 where she is developing skills in GMP manufacture of biologics, aseptic cell culture as well as manufacture and sterilisation of biomaterials.
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Ricardo P. Araújo
- BSc, MSc – Quality Control Assistant
Holds a degree in Biochemistry and a Master's degree in Applied Biochemistry in the field of Biomedicine from the University of Minho. Working at Stemmatters since 2017, acquiring skills in cell culture, process development, manufacturing in GMP environment and development and implementation of routine and non-routine testing of raw materials for products under development or finished formulations.
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Mafalda P. Cautela
- BSc, MSc - Junior Research Scientist
Graduated in Biochemistry. Hands-on experience in the biomedical and pharmaceutical fields. Expertise in the development of nanoparticles for medical imaging and drug delivery and aseptic cell culture. Joined Stemmatters in May 2019 working on the synthesis and in vitro performance testing of novel biomaterials.
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Cristiana Branco da Cunha
- BSc, Ph.D – Head of Business Development
Graduated in Applied Biology from the University of Minho (Portugal) and a PhD in Biomedicine from the University of Porto in collaboration with Harvard University (Cambridge, USA). With a life sciences scientific background by training, has over 10 years experience in the fields of tumor biology, tissue engineering and biomaterial-based medical devices. Currently responsible for project management and implementation, technology transfer operations and R&D and pre-clinical development activities.
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André M. Soares
- Ph.D, MBA – Business Development Manager
André is a business-oriented scientist that holds a Bsc and a MsC in Biochemistry by the University of Coimbra, Portugal, as well as a PhD in Molecular and Cell Biology by the University of Coimbra in collaboration with the University of Massachusetts, Amherst. At a later stage of his career he decided to strengthen his education and he now holds an MBA by Porto Business School, Portugal. André has a scientific background in protein production and engineering initially in the plant biotechnology field and later in the Immuno-oncology field. At Stemmatters he is helping in the business development efforts of the company.
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Paula A. Mendes
- BSc – Managment Assistant
Graduated in fiscal law from the Instituto Politécnico do Cávado e do Ave. Broad experience in administrative, financial, accounting and management areas gained through working as a consultant for Financial and Administrative Departments. More than 8 years experience in management and control of various company processes, from the creation and management of customer and supplier accounts, credit risk analysis, receipts and payments to coordination of Human Resources teams.
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Teresa M. Cunha
- BEc, MPA – Financial Controller
Holds a degree in Economics from Beira Interior University (UBI), and a Master's in Public Management from the University of Trás-os-Montes and Alto Douro (UTAD). Is a Chartered Accountant with over 20 years of experience in Corporate Finance and Sustainability Reporting. Several years of academic experience, having taught Financial Accounting, Business Finance and Financial Management at UTAD. Skilled in Circular Economy and Corporate Social Responsibility. Is a PhD student in Management.
Carla Vozone
- PharmD, MSc, MBA
Carla is a pharmaceutical business leader and spearhead of innovative growth strategies in drug delivery grounded on 20+ years of expertise in regulatory, drug development and commercialization aspects. She is the Vice-President of Pharmaceutical Development and Licensing at Hovione, where she is responsible for the strategy and operations of Hovione’s portfolio of proprietary medicines. During her career she held roles in Sales and Marketing in Europe and North America and Global business development. Carla is a PharmD and MSc from the University of Lisbon and an MBA from Rutgers Business School.
Cathy Prescott
- BSc, PhD
Cathy has over 20 years of experience in research, management and business in the biotechnology, pharmaceutical and venture capital sectors. She has multiple commitments including as the Founder Director of the life-sciences consultancy firm Biolatris Ltd., Non-Executive Director at Videregen Ltd., Advisory Board chair at Trakcel Ltd., Translation Advisory Group member at Babraham Institute and Member of the Board of Trustees IMET2000.
João Espregueira-Mendes
- MD, PhD
João is a world renowned knee orthopedic surgeon with a long track record in sports orthopedic, traumatology and knee surgery. During his career, he has been engaged in scientific research, university teaching, leadership of both national and international scientific societies and in the clinical practice as Clinical Director of the Clinica do Dragão, Espregueira-Mendes Sports Center - FIFA Medical Center of Excellence.
Gordon Wallace
- BSc, PhD
Gordon is a leading scientist in the field of electromaterials. As a scientist he has developed new approaches to fabrication that allow material properties discovered in the nano world to be translated into micro structures and macroscopic devices. His main research interests include the discovery of new materials and the use of these in energy and biomedical devices.
Diogo Moreira Rato
- BSc, PhD
Diogo brings more than 34 years of senior global business executive offering in the life sciences, medical devices and diagnostics industries, having worked as President and Executive Officer of different divisions of Fortune 100 companies across major regions of the USA, Europe and Latin America. Proven abilities in human capital, pipeline development, mergers and acquisitions, manufacturing and regulatory. Expertise encompasses strategy, multinational operations, global marketing, and new business development.
Seppo Makinen
- BSc, PhD, DSc
Seppo's career includes prolific experience as a director and investor in multiple life sciences companies and investment funds. His achievements include public listing of nine companies on international stock exchanges. Seppo built one of the leading life science Venture Capital companies in Europe, and has held close to fifty international board positions in life science companies. Seppo holds a degree of M.Sc in physical chemistry from Jyvaskyla University and before his VC career was an expert on gas / liquid chromatography, including laboratory R&D and sales / marketing positions in Millipore / Waters.
Yves Bayon
- MD, PhD
Yves Bayon, PhD & MBA, Chief Scientist (Medtronic, France) has held various missions, including implementation of porcine collagen manufacturing line and development of medical devices for soft tissue repair. Its missions have expanded with Medtronic from 2015: cross-functional activities with expert roles & access to public funding. He has also external activities: as GTech member (Lyonbiopole), and scientific advisor of several start-ups.
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 according to your requirements. 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
Stemmatters has a deep commitment to quality. We maintain stringent in-house quality policies and seek continuously opportunities to improve our practices.
Stemmatters follows the requirements of EN ISO 9001: 2015 - Quality Management Systems and NP 4457 Research, Development and Innovation (RDI) Management Systems.
- Our clean rooms are certified for manufacturing of human investigational medicinal products
- All critical processes are validated, and all critical equipment and utilities are qualified as described in our Validation Master Plan
- Quality Management System in conformity with the European Good Manufacturing Practice (GMP) and ICH Q7 guidelines
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.
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.
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)
Contact Us
+351 253 165 230 info@stemmatters.com