MaaT Pharma, a biotech company based in France, has built a cGMP microbiome ecosystem therapeutics manufacturing facility near Lyon (Saint-Quentin-Fallavier) in France in collaboration with Skyepharma, a French pharmaceutical contract development and manufacturing organisation (CDMO).
The facility is utilised exclusively for the clinical and commercial-scale production of microbiome-based ecosystem therapy (MET) of MaaT Pharma, the first resident company in Skyepharma’s Skyehub Bioproduction.
Skyehub Bioproduction is an innovative model that provides biotech companies with the essential capabilities and services for clinical and commercial production.
With the funding from Skyepharma, the facility’s construction started in July 2022 and was completed in September 2023.
MaaT Pharma partnered with Skyepharma to develop the facility in February 2022.
The collaboration initially provided MaaT Pharma with a 1,500m² site for dedicated production of biotherapies from microbiota, which can be expanded to twice its size if required. The expansion will bolster MaaT Pharma’s cGMP manufacturing capabilities to support their leading product candidates’ clinical and commercial advancement, MaaT013 and MaaT033.
Additionally, it will enable the expansion of MaaT Pharma’s research and development (R&D) manufacturing capabilities to support the development of the new generation drug line, MaaT03X.
The facility is located within Skyepharma’s SkyeHub Bioproduction in Saint-Quentin-Fallavier, France.
The SkyeHub Bioproduction is spread over more than 20,000m² (2ha) of land, which Skyepharma allocated for the construction of dedicated buildings with specially designed premises along with transverse support services, such as quality, maintenance, batch release, and more.
Details of the microbiome facility
The state-of-the-art microbiome facility is built on a 17,200ft2 (185,139ft2) area. It includes production facilities covering an area of 564m2, an R&D laboratory spanning 234m2, a storage space of 100m2 stretching across two levels, and additional administrative and technical areas totalling more than 700m2.
The facility is equipped with MaaT Pharma’s proprietary equipment to produce its diverse portfolio of enema and capsule drug candidates. It features a dedicated area for R&D and clinical manufacturing of the MaaT03X range, using MaaT Pharma’s unique proprietary microbiome ecosystem co-fermentation technology, by 2030. MaaT03X represents a range of highly specialised microbiome ecosystems that have been customised for specific medical indications.
MaaT Pharma’s standardised cGMP manufacturing and quality control process helps produce MET to safely deliver the complete range of microbiomes in liquid and oral formulations.
The facility will allow MaaT Pharma to expand its manufacturing capacities by ten times to support clinical and commercial development by 2030.
Microbiome facility production details
The facility manufactures 9,000 pouches of MaaT013 a year dedicated to Graft-versus-Host disease (GvHD). Additionally, it supports the production of 1.3 million capsules of MaaT033 a year, designed to improve the survival rate in patients receiving allogeneic stem cell transplantation.
The facility manufactures up to 300,000 capsules of MaaT03X annually. The novel class of MET products, designed from clinical data, encompasses a wide array of species.
Marketing commentary on MaaT Pharma
MaaT Pharma is dedicated to treating cancer and GvHD, a severe complication that can occur after allogeneic stem cell transplantation.
MaaT Pharma’s MET is a specialised product tailored to specific medical conditions. The products are designed to harness the full functional potential of a vast microbiome ecosystem boasting high diversity and richness.
MaaT Pharma has pioneered a ground-breaking global platform for the development and production of MET-N (MaaT013 and MaaT033), native products derived from donors. MET-N serves as a therapeutic intervention aimed at restoring symbiosis, particularly in cases where patients frequently suffer from severe dysbiosis, often induced by medical treatments.
MaaT Pharma has utilised the information gathered from native products to create a next-generation line of products known as MET-C (MaaT034 and MaaT03X). MET-C products are designed to serve as immune-modulating therapies for individuals with solid tumours who are undergoing treatment with immune checkpoint inhibitors.
One of MaaT Pharma’s notable assets is its artificial intelligence (AI)-powered drug discovery and analysis platform, gutPrint, which allows researchers to identify potential disease targets within the context of microbiome-related conditions.