MaaT Pharma and CDMO Skyepharma complete new microbiome facility in France

MaaT Pharma and CDMO Skyepharma have just completed building what might be the largest cGMP microbiome facility in Europe. Completed in 12 months, the 17,200 square foot facility in France was designed from scratch to specifically house the manufacturing of MaaT’s microbiome cancer therapies.

Lyon, France-based MaaT harvests stool samples from healthy donors, which are mixed together to form a suspension and administered to patients. The biotech has three cancer assets under investigation based on its approach.

Laurent Rigaudeau

The new facility is the first resident at Skyepharma’s Skyehub Bioproduction site in Saint-Quentin-Fallavier, France. The site is now operational with equipment and process qualification operations, Skyepharma chief business officer Laurent Rigaudeau told Endpoints News. The site’s first production campaign will start by the end of this month.

MaaT is perhaps one of the few microbiome companies that oversees the full process of producing microbiota therapies, including managing donor-derived and co-cultured candidates in a GMP environment. The new site is operating on biological safety level 2.

Due to the nature of MaaT’s raw materials, the company faced numerous challenges in developing its microbiota therapies. The FDA only lifted its clinical hold on MaaT’s Phase III MaaT013 trial in acute graft-versus-host disease (GVHD) in April this year, 18 months after the agency initiated the hold in Aug. 2021. The FDA requested further clinical and manufacturing data on the safety and efficacy of MaaT’s approach to mixing donor samples.

The tight safety and regulatory concerns around MaaT’s raw materials led to manufacturing constraints, with the company previously struggling to find a CDMO partner, said Carole Schwintner, MaaT’s chief technology officer. 

Carole Schwintner

The microbiota is highly sensitive, for instance requiring little oxygen to stay viable, Schwintner added. This requires specific processes to maintain the viability of the bacteria from the beginning to the end of the manufacturing process.

“We have developed a process so that we are able to maintain the entire bacterial community viability, so that of course in the end, the drug is still active when we transfer it to the patient,” Schwinter said.

CMO ABL Europe previously hosted MaaT’s GMP production since 2016. MaaT’s production and development teams have been transferred to the new facility at the Skyehub.

The unique demands of microbiota-based therapy manufacturing led to the partnership between MaaT and Skyepharma, which was first announced in Feb. 2022. “I think it’s more than a partnership. We are really working hand in hand to build the model and operate the facility,” said Rigaudeau.

Skyepharma specializes in the manufacturing, development and packaging of drugs and oral technologies. MaaT and Skyepharma’s partnership could lead to over a dozen new specialized jobs over the next few years, according to a press release.

MaaT’s lead microbiome asset is MaaT013 in a Phase III GVHD trial and in a Phase II test for metastatic melanoma. Meanwhile, MaaT033 showed positive Phase Ib trial results in June 2022 for acute myeloid leukemia. MaaT033 is also due to enter a Phase IIb trial in patients with hematological malignancies receiving allogeneic hematopoietic stem cell transplantation. As for its third candidate, MaaT03X is under consideration in solid tumors and is undergoing preclinical testing.

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