Pharma Focus Europe

Philogen S.p.A. Receives GMP Certification for New Production Facility in Rosia, Italy

Wednesday, December 06, 2023

Philogen S.p.A. (BIT:PHIL) is thrilled to announce that its new GMP facility in Rosia Siena has received GMP certification. The Agenzia Italiana del Farmaco (AIFA)'s GMP MED office granted the certification following an inspection in July 2023, confirming compliance with Good Manufacturing Practice standards outlined in Directive 2003/94/EC of the European Parliament.

Within the EU, national competent authorities, such as AIFA in Italy, are responsible for inspecting manufacturing sites within their territories. Philogen's new facility benefits from mutual recognition agreements (MRAs) signed by the European Commission with authorities in the United States, Switzerland, Canada, Israel, Australia, Japan, and New Zealand.

The Rosia plant was designed in accordance with the new Annex 1 of the Rules Governing Medicinal Products in the European Union, with plans to produce therapeutic proteins in mammalian cells, focusing on Philogen's immunocytokines such as Nidlegy™ for clinical trials and commercial purposes. The facility required an investment of over 15 million Euros.

Following positive Phase III trial results for Nidlegy™ in patients with locally advanced fully resectable melanoma (NCT02938299) announced on October 16, 2023, the Rosia facility will manufacture commercial supplies of Nidlegy™ for global distribution.

Prof. Dario Neri, co-founder, CEO, and CSO of Philogen, expressed, "The GMP Certificate by AIFA for our new Rosia site is an important milestone, reinforcing Philogen's transition from research to a commercial company after the positive Phase III trial results of Nidlegy™."

Dr. Duccio Neri, co-founder and Executive Chairman of Philogen, added, "Our state-of-the-art GMP facility in Rosia, built with multi-million euros investments, positions us to supply life-saving medicines globally. Philogen's commitment to expanding production capacity and hiring talented individuals in Italy has been instrumental in achieving this milestone."



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