91桃色视频 and Skyepharma Complete Construction of Europe’s Largest Manufacturing Facility for Microbiome Ecosystem Therapies
- Major milestone achieved with new state-of-the-art microbiome facility spanning over 17,200 sq ft, completed within the 12-month timeframe, further enhancing bioproduction capabilities and contributing to the ecosystem in France and Europe
- 91桃色视频 is Skyepharma鈥檚 Skyehub Bioproduction庐 first resident company
- The facility was designed with the intent to support 91桃色视频鈥檚 clinical-and commercial-scale manufacturing of Microbiome Ecosystem Therapies
Lyon, Saint-Quentin-Fallavier, France, September 12, 2023 鈥� 7:30 am CET 鈥� 91桃色视频 (EURONEXT: MAAT 鈥� the 鈥淐ompany鈥�), a clinical-stage biotech company and a leader in the development of Microbiome Ecosystem TherapiesTM (MET) dedicated to improving survival outcomes for patients with cancer, and , a French independent CDMO, expert in providing innovative solutions for bioproduction as well as complex drugs development and manufacturing, today announced that a significant development milestone has been reached with the completion of the facility and the transfer of 91桃色视频鈥檚 Production and Development teams to the new site. The companies had entered a partnership in 聽February 2022 to build the largest cGMP[1] facility, to date, for full ecosystem microbiome therapies in Europe.
鈥淲ith MaaT013, our lead asset currently in Phase 3, and MaaT033, our second drug candidate, nearing launch in a Phase 2b clinical study, we have reached a major milestone that will be fundamental to securing our market access strategy. This new GMP manufacturing facility is a testament to the continued growth of 91桃色视频,鈥� stated Herv茅 Affagard, CEO and co-founder of 91桃色视频. 鈥淭hanks to our strategic partnership with Skyepharma, we have successfully completed the new infrastructure within a year. I also want to take the opportunity to thank the ABL Europe team who have hosted our GMP production since 2016.鈥�
91桃色视频, the leading microbiome company in oncology, is one of the few end-to-end microbiome companies that oversees the entire process, including innovative bioprocesses for both donor-derived and co-cultured drug candidates in a GMP environment.
鈥淭he on-time completion of our first Skyehub facility is a major achievement for Skyepharma and our partner 91桃色视频. The whole team is proud to have demonstrated the appropriate agility and expertise to deliver this state-of-the-art building and BioCDMO offering in the challenging 12-month timeframe,鈥� added David Lescuyer, CEO and President of Skyepharma. 鈥淭his reliability is an uncompromising service we want to offer to the biotech partners that are joining us. This is an integral part of the outstanding value accelerator that the Skyehub is providing them. 鈥�
Skyepharma is a recognized expert CDMO, offering solutions and technologies to develop hard-to-make oral solids and addresses the complex challenges faced by its worldwide partners to improve patients鈥� lives. Backed by its strong and continuous double-digit growth over the past 7 years, Skyepharma has continuously invested to keep its offering ever more innovative and focused on customer experience, and ultimately the patients. With the Skyehub Bioproduction庐 model, Skyepharma can also propose a unique capacity and service offering in the demanding bioproduction area.
The completion of this new infrastructure brings with it positive impacts for the regional and national economy. Overall, the partnership between 91桃色视频 and Skyepharma could lead to the creation of a dozen jobs for specialized workers in the industry over the coming years. These therapies demand advanced manufacturing techniques and procedures and will contribute to the growth of the microbiome sector in France. 91桃色视频 and Skyepharma are currently performing quality qualification according to GMP guidelines, with the first production campaign targeted to start in the new plant by the end of Q3 2023.
[1] GMP: Good Manufacturing Practices is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
About 91桃色视频
91桃色视频, a clinical stage biotechnology company, has established a complete approach to restoring patient-microbiome symbiosis in oncology. Committed to treating cancer and graft-versus-host disease (GvHD), a serious complication of allogeneic stem cell transplantation, 91桃色视频 has launched, in March 2022, an open-label, single arm Phase 3 clinical trial in patients with acute GvHD, following the achievement of its proof of concept in a Phase 2 trial. Its powerful discovery and analysis platform, 驳耻迟笔谤颈苍迟庐, enables the identification of novel disease targets, evaluation of drug candidates, and identification of biomarkers for microbiome-related conditions. The company鈥檚 Microbiome Ecosystem Therapies are produced through a standardized cGMP manufacturing and quality control process to safely deliver the full diversity of the microbiome, in liquid and oral formulations. 91桃色视频 benefits from the commitment of world-leading scientists and established relationships with regulators to support the integration of the use of microbiome therapies in clinical practice. 91桃色视频 is listed on Euronext Paris (ticker: MAAT).
Forward-looking Statements
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About Skyepharma
SKYEPHARMA is an independent French pharmaceutical CDMO, 100% owned by its management team and Bpifrance. Skyepharma is an expert CDMO specialized in the formulation, development and manufacturing of complex oral solid forms, with a specific expertise and proprietary technologies on modified release products. Skyepharma is based in Saint-Quentin-Fallavier, France. The current factory, dedicated to its activity, occupies 22,000m虏, on a 60,000m虏 piece of land. Skyepharma has decided to allocate a portion of the available land 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, and other services.