MaaT Pharma and SkyePharma to establish the first microbiome-based therapeutics manufacturing facility in France
MaaT Pharma and Skyepharma have entered a partnership agreement to build SkyeHub Bioproduction, a new manufacturing facility near Lyon. This new plant will be France’s largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics. SkyeHub Bioproduction is expected to be operational in 2023.
MaaT Pharma, a French clinical-stage microbiome-based therapeutics company, and the fully integrated French CDMO Skyepharma have entered a partnership agreement to build the first exclusive microbiome ecosystem therapies cGMP manufacturing facility in France, near Lyon (Saint-Quentin-Fallavier). Under the terms of the agreement, MaaT Pharma will have a dedicated facility within the new plant and construction will be financed by Skyepharma. The CDMO’s current factory in Saint-Quentin-Fallavier, occupies 22,000m², on a 60,000m² piece of land. Skyepharma has decided to allocate a portion of the available land (more than 20,000m²) to establish the SkyeHub Bioproduction, an innovative model designed to offer clinical and commercial production capacities to biotech companies. This SkyeHub model includes the construction of dedicated buildings, with specifically designed surfaces and premises, together with transverse support services such as quality, maintenance, batch release, etc. In addition to providing the cGMP building, Skyepharma will also provide its extensive expertise in product quality standards, regulatory affairs, certification, and large-scale production.
The new plant will allow MaaT Pharma to increase its manufacturing capacities ten-fold in order to support clinical and commercial development by 2030. The facility will cover an initial area of 1,500 m², that could be increased to 3,000 m² depending on MaaT Pharma’s manufacturing needs. It will aim to annually produce several thousand enemas of its lead candidate (MaaT013) dedicated to graft-versus-host disease and several hundreds of thousands capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation. This new plant will also allow MaaT Pharma to accelerate the development of MaaT03X, its new generation of drug candidates, using its unique proprietary microbiome ecosystem co-fermentation technology, for which the company was recently awarded two public grants (Plan France Relance and the 4th Programme d’Investissements d’Avenir (PIA4)). A designated area will be dedicated to R&D and clinical manufacturing of the MaaT03X range by 2030, using MaaT Pharma’s innovative ecosystem co-fermentation technology to increase response rate in immunotherapy treatments. “As we enter Phase 3 with our lead product MaaT013, the agreement with Skyepharma will allow us to scale up manufacturing to meet product demands, including commercial launch. We can look forward to expanding our product portfolio for cancer patients with serenity,” commented Hervé Affagard, co-founder and CEO of MaaT Pharma. “This partnership is fully in line with France’s ambition, as stated in the 2030 innovation plan for health, to become a nation at the forefront of biotherapies and ensure health independence in biomanufacturing. The emerging microbiome industry could open up an opportunity to position France as a leader.” David Lescuyer, Managing Director of Skyepharma added, “SkyeHub will increase cGMP production capacity for microbiome-based drugs in France. Our partnership acts as a value booster as each company brings its know-how and expertise.”
02/03/2022
MaaT Pharma and SkyePharma to establish the first microbiome-based therapeutics manufacturing facility in France
MaaT Pharma and SkyePharma to establish the first microbiome-based therapeutics manufacturing facility in France
MaaT Pharma and Skyepharma have entered a partnership agreement to build SkyeHub Bioproduction, a new manufacturing facility near Lyon. This new plant will be France’s largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics. SkyeHub Bioproduction is expected to be operational in 2023.
MaaT Pharma, a French clinical-stage microbiome-based therapeutics company, and the fully integrated French CDMO Skyepharma have entered a partnership agreement to build the first exclusive microbiome ecosystem therapies cGMP manufacturing facility in France, near Lyon (Saint-Quentin-Fallavier). Under the terms of the agreement, MaaT Pharma will have a dedicated facility within the new plant and construction will be financed by Skyepharma. The CDMO’s current factory in Saint-Quentin-Fallavier, occupies 22,000m², on a 60,000m² piece of land. Skyepharma has decided to allocate a portion of the available land (more than 20,000m²) to establish the SkyeHub Bioproduction, an innovative model designed to offer clinical and commercial production capacities to biotech companies. This SkyeHub model includes the construction of dedicated buildings, with specifically designed surfaces and premises, together with transverse support services such as quality, maintenance, batch release, etc. In addition to providing the cGMP building, Skyepharma will also provide its extensive expertise in product quality standards, regulatory affairs, certification, and large-scale production.
The new plant will allow MaaT Pharma to increase its manufacturing capacities ten-fold in order to support clinical and commercial development by 2030. The facility will cover an initial area of 1,500 m², that could be increased to 3,000 m² depending on MaaT Pharma’s manufacturing needs. It will aim to annually produce several thousand enemas of its lead candidate (MaaT013) dedicated to graft-versus-host disease and several hundreds of thousands capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation. This new plant will also allow MaaT Pharma to accelerate the development of MaaT03X, its new generation of drug candidates, using its unique proprietary microbiome ecosystem co-fermentation technology, for which the company was recently awarded two public grants (Plan France Relance and the 4th Programme d’Investissements d’Avenir (PIA4)). A designated area will be dedicated to R&D and clinical manufacturing of the MaaT03X range by 2030, using MaaT Pharma’s innovative ecosystem co-fermentation technology to increase response rate in immunotherapy treatments. “As we enter Phase 3 with our lead product MaaT013, the agreement with Skyepharma will allow us to scale up manufacturing to meet product demands, including commercial launch. We can look forward to expanding our product portfolio for cancer patients with serenity,” commented Hervé Affagard, co-founder and CEO of MaaT Pharma. “This partnership is fully in line with France’s ambition, as stated in the 2030 innovation plan for health, to become a nation at the forefront of biotherapies and ensure health independence in biomanufacturing. The emerging microbiome industry could open up an opportunity to position France as a leader.” David Lescuyer, Managing Director of Skyepharma added, “SkyeHub will increase cGMP production capacity for microbiome-based drugs in France. Our partnership acts as a value booster as each company brings its know-how and expertise.”
02/03/2022
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