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Service

Stemmatters

Stemmatters provides bespoke product, process and analytical development services tailored to each client’s needs. We have a strong track record of seamless technology transfer procedures, assuring the ability to validate your optimised solutions in-house.

Core Capabilities

Stemmatters operates as a Contract Development and Manufacturing Organization (CDMO), providing competitive cost-effective solutions to early-stage developers of biological and cellular therapeutics.

Stemmatters offers a full range of development and manufacturing services to stakeholders developing products based on, or derived from, human cells and tissues.

Through years progressing our proprietary research programs, we have encompassing competence working with cell and tissue products and implantable medical devices. We offer services for cell-based advanced therapy medicinal products (ATMPs), cell and tissue products, biomaterial-based medical devices, and blood- and cell-derived biologics such as exosomes.

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Our central objective is to ensure the success of each of our customers, protecting your quality specification while minimizing costs. We offer diligent and reliable services to developing new products and manufacturing processes according to your requirements.

Our flexible approach enables us to meet your specifications within your timelines, thus integrating seamless coordination with your own development program and adding value to your assets. Our core capabilities include:

  • Translation of non-GMP protocols into fully scalable, reproducible and validated GMP-compliant processes
  • Formulation development
  • Analytical development
  • Cost of goods (COGs) optimization
  • Process optimization
  • Aseptic fill and finish
  • Quality assurance and control
  • Establishment of master and working cell banks
  • cGMP storage at room temperature, refrigerated, ultra-low freezing and cryopreservation temperatures
Facilities

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.

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  • 10 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 committment to quality. We maintain stringent in-house quality practices and are always seeking opportunities to augment our framework.

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

 

Partnering

Stemmatters adopt a practical and flexible approach to partnering with various stakeholders in Portugal and across the world. 

Every opportunity is considered case-by-case, so we encourage you to engage with us and begin the conversation. Partnering closely with Stemmatters also draws on the benefit of accessing 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.

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 our projects, extracting maximum benefit from our resources and capabilities while mitigating the risk of delay. We have a communicative and transparent project management style, ensuring you have full visibility of your project's status.

Our project management platform provides tools for the effective management of multiple complex development or manufacturing projects in parallel.

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Company Service Catalog

Download our company service catalog here.

Our company service catalog provides useful further information about our company and service offering. You are welcome to share the document with your colleagues as you please.

Please click this link to download the catalog .

We would also be very happy to post you a hard copy free of charge upon request .