Stemmatters is a Portuguese contract development and manufacturing (CDMO) organisation based in Barco, Guimarães. Originally a spin-off from University of Minho, it offers contract development and manufacturing services for cell-based advanced therapies, exosomes, blood-derived biologics, tissue products, biomaterials, and combination devices.
In the interview below, we explore Stemmatters history, services, manufacturing facilities, and future goals. Enjoy!
Interview with Oliver Ball, Business Development Manager at Stemmatters
Cade Hildreth: When was Stemmatters founded and why?
Oliver Ball: Stemmatters was originally founded in 2007 for the purpose of translating academically developed technologies in the regenerative medicine space into investable assets. Since then we have evolved from an integrated therapeutics developer into a co-development partner and fully-fledged CDMO company, with deep technical expertise in GMP operations, preclinical product and process development, and quality and compliance strategy.
Cade Hildreth: Who were the founding members?
Oliver Ball: Stemmatters was created as a spin-off of the 3B’s Research Group at University of Minho, Portugal. The founders were Rui Sousa, who is the CEO, and Rui Reis, Director of 3B’s Research Group at University of Minho. Since its creation, the company has evolved as a fully private and independent company, collaborating with numerous research and academic institutions, as well as companies worldwide.
Cade Hildreth: My understanding is the Stemmatters functions as a hybrid CDMO, meaning it both develops regenerative medicine products and offers contract manufacturing services to other organizations. How did you decide to create this hybrid structure?
Oliver Ball: The biomaterials pipeline we are developing has been with the company for several years, but is just one of several projects we have a development role in. We wanted to leverage our expertise and experience with biomaterial and combination device products alongside our GMP facility to bring more value to the company, so have recently raised capital to launch a CDMO business unit. Stemmatters is unique in that we offer substantially more flexibility in how we engage with our clients than traditional companies offering only fee-for-service contracts.
Whilst we do of course offer fee-for-services to our clients, we also like to discuss opportunities to enter co-development partnerships. Beginning our relationship at an earlier stage and taking part ownership of a project means we can really accelerate the translation of those technologies into GMP-compliant, commercial-ready, closed product processes more efficiently than would otherwise be possible.
This approach means we are willing to take on some of your development risk in return for exposure to potential future benefits, which makes an attractive strategy for those with early-stage assets. This unique structure really developed out of an opportunity to leverage our infrastructure and non-clinical development expertise for the benefit of third parties, and a desire to bridge the ‘valley of death’ that early technology developers face.
The work we do internally, both on our own pipeline and in co-development partnerships, adds substantial breadth to our technical expertise that would not be accessible with a singular business model.
Cade Hildreth: My understanding is that Stemmatters is developing novel encapsulation matrices to provide cell delivery into the body by minimally invasive methods. Can you tell me more about this technology and your products under development?
Oliver Ball: Such technology has resulted from the biomaterials pipeline internally developed at the company. We have developed an innovative platform aimed at cell encapsulation and delivery with potential application in multiple clinical areas. With this platform, we aim to address opportunities in the advanced therapy field in need of accurate delivery, high cell retention and engraftment at target site.
Our products are chemically defined rendering an injectable cell-based formulation, presenting high biocompatibility and low immunogenicity induced response. In this area, we typically pursue strategic co-development collaborations for development of new candidates.
Cade Hildreth: What types of CDMO services does Stemmatters offer?
Oliver Ball: We are a full-service company offering development support right from preclinical stage through to clinical and commercial supply, depending on scale requirements. Our core competencies include COGs optimisation, GMP protocol optimisation and validation, analytical quality control method development, semi-automated fill & finish, establishment of master and working cell banks, and more.
We also offer GMP storage at -80oC, in liquid nitrogen, or at refrigerated or ambient temperatures. Our technical experience and service offering extends beyond cell therapy and combination devices, into cell-derived biologics such as exosomes and conditioned media, and blood-derived biologics such as human platelet lysate.
Cade Hildreth: What types of facilities do you have on site to support your CDMO services?
Oliver Ball: Our facility features 8 cGMP compliant cleanroom areas, 3 Grade C/ISO 7 manufacturing rooms (capable of running at Grade B) fitted with aseptic Isolators (Grade A/ISO 5), 2 Grade D/ISO 8 support rooms, a cryostorage room, a dedicated room for aseptic filling (including semi-automatic equipment), and a dedicated manufacturing room for cell expansion protocols.
We also have all the peripheral GMP infrastructure you would expect, such as pharmaceutical-grade CO2, LN2 supplies, environmental and particulates monitoring, and temperature and pressure monitors. We implement aseptic filling operations in multiple formats and sizes, and will be soon adding GMP freeze drying.
Cade Hildreth: What is Stemmatters’ background or expertise in manufacturing advanced therapy products, such as cell therapies, exosomes, and other types of cell-derived biologics?
Oliver Ball: Our background is actually centred in biomaterials, tissue engineering and blood-derived biologics, but we are rapidly growing into the advanced therapy space as an area of strategic priority. Many of the processing solutions across technology domain share similarities, and our deep expertise in sterile closed-process manufacturing as applied to other technologies has direct bearing to handling advanced cell therapies.
Cell-derived biologics such as exosomes and conditioned media are another area where we have deep experience in analogous handling steps, and our facility features all the requisite infrastructure to deliver value in these technology domains.
Cade Hildreth: With most CDMOs being headquartered in the U.S., Europe, and Asia, what are the benefits of being headquartered in Portugal?
Oliver Ball: As a member of the European Union, operating in Portugal places us very competitively within the European market. Our relatively small size compared to other CDMO’s means that we are open to engaging with smaller and earlier-stage clients who are looking for translational and early clinical stage manufacturing that is unlikely to be relevant for larger CDMOs. Being in Portugal also enables us to provide very competitive rates compared to what would be affordable in countries like the UK or Germany.
We also have the benefit of being located near to the Porto International Airport (OPO) and have strong working relationships with the main universities, research centres and clinical sites around the country, including large size hospitals and leading integrated cancer treatment centres. Portugal is currently a relatively untapped market in the advanced therapy space, and we aim to be not only a gateway to Portugal as a country but to the wider European market.
Cade Hildreth: What are your 3-5 year goals for Stemmatters?
Oliver Ball: At Stemmatters we are aiming to rapidly grow into the cell processing sector to consolidate our position as a highly competitive European CDMO. Our goals are to deepen our track record in advanced therapies with the outcome of supporting the translation of innovative advanced therapy technologies into the clinic and onto commercial success. We also aim to broaden our co-development pipeline, working with select partners to bring their technologies forward by accessing and benefiting from our technical expertise.
Cade Hildreth: How can people get in touch with you or learn more about Stemmatters?
Oliver Ball: For any general or business development enquires, you can reach me directly at omball@stemmatters.com. If you want to enquire about a partnering opportunity, the best address is partnering@stemmatters.com.
Do you have questions about Stemmatters or their CDMO services? Ask them in the comments below.
For more information about companies specializing in advanced therapy manufacturing, view the “Global Database of Cell and Gene Therapy CMOs / CDMOs.”