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.
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:
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”.
Stemmatters expects its external providers to comply with the contractual agreements, current regulations and guarantee the conformity of the products/services.
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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.