Week's news analysis

MaaT Pharma and Skyepharma will build
a cGMP manufacturing plant
for ecosystem microbiome-based therapeutics

By Editors - 09 February 2022
Skyeparma Saint Quentin Fallavier plant / DR

MaaT Pharma, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. MaaT Pharma and Skyepharma, have entered a partnership agreement to build, to date, France's largest specialized cGMP manufacturing facility for ecosystem microbiome-based therapeutics.

Skyepharma is an independent French pharmaceutical CDMO, 100% owned by its management team and Bpifrance. Skyepharma is based in Saint-Quentin-Fallavier, France. The current factory, dedicated to its OSD activity, 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 its 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.

Under the terms of the agreement, MaaT Pharma will have a dedicated facility within SkyeHub Bioproduction and construction will be financed by Skyepharma.

The facility will boast an initial area of 1,500 square meters, that could be increased to 3,000 square meters depending on MaaT Pharma's manufacturing needs. The plant will allow MaaT Pharma to increase its manufacturing capacities ten-fold in order to support clinical and commercial development by 2030.

It is planned that the production site, expected to be operational in 2023, will host MaaT Pharma's team and proprietary equipment. In this context, the Lyon-based biotech will retain controlling oversight of the R&D as well as clinical and commercial production of its diverse portfolio of enema and capsule drug candidates. 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 facility will aim to annually produce several thousand enemas of the Company's lead candidate (MaaT013) dedicated to Graft-versusHost disease and several hundreds of thousands capsules of its second drug candidate (MaaT033) designed to improve survival in patients receiving allogeneic stem cell transplantation.

"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.

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."

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 cofermentation technology, for which the Company was recently awarded two public grants (Plan France Relance and the 4th Programme d'Investissements d'Avenir (PIA4)). This new oral class of MET products includes hundreds of species and is tailor-made based on clinical data.

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