issue2_2025_247BIOPHARMA

21 TWENTYFOURSEVENBIOPHARMA Issue 2 / June 2025 the MFA-led Working Group on the internationalization of Italy’s biotech industry. The Tour—whose itinerary spans the globe from San Francisco to Singapore—aims to translate the think tank’s recommendations into the U.S. market and lay the groundwork for new industrial and scientific partnerships. The Consul General of Italy in Boston Arnaldo Minuti commented: “We are pleased to welcome the Montalcini Global Biotech Tour to the Consulate General of Italy in Boston, an initiative that celebrates Italian scientific excellence and promotes dialogue with one of the most advanced and competitive biotech ecosystems in the world. Boston is home to nearly 1,000 biotech companies and over 140,000 life sciences professionals. Italy is an integral part of this global network through leading companies, strategic investments, and a vibrant community of Italian researchers, scientists, and executives. This event offers a valuable platform to foster new collaborations, strengthen economic ties between Italy and the US, and the Italian contribution to global innovation and health”. The Italian Pavilion at BIO 2025 Italian companies traveling to Boston will showcase technologies that span the entire life-science value chain. Highlights range from 3DD “beating” organ-on-chip models for highly predictive drug testing to hematopoietic stem-cell therapies; first-in-class plant-based immunotherapies for autoimmune diseases; in-silico simulation platforms and digital twins that forecast a compound’s safety and efficacy; AI-powered, non-invasive metabolic diagnostics; and super-resolution fluorescence microscopy systems. On the manufacturing side, Italy’s CDMOs cover every link in the chain—from complex API synthesis and GMP-grade plasmid and mRNA production for vaccines and advanced therapies to large-scale oral soliddosage formulation. Alongside these solutions, regional clusters, science parks, and investment-promotion agencies will present territorial ecosystems, incentives, and infrastructure—from local life-science networks and soft-landing programs to precisionmedicine hubs, biotech parks, and specialized IP services coordinated by the national Invest in Italy unit. Exhibitors in the Italian Pavilion at BIO 2025 include Anemocyte (Varese), BiomimX (Milano), Chemi (Milano), CrestOptics (Roma), Diamante (Verona), Genenta Science (Milano), ICROM (Monza), InSilicoTrials (Trieste), Math Biology (Roma), Menarini Biotech (Roma), Valpharma International (Rimini). They are joined by the Ri.MED Foundation, the HEAL Italia Foundation and Società Italiana Brevetti. On the institutional side, Boston will host Bioindustry Park “Silvano Fumero”, Clust-ER Health EmiliaRomagna, Cluster Lombardo Scienze della Vita, Invest in Lombardy, Invest in Trentino, Invest in Tuscany, Life Science Cluster Friuli Venezia Giulia – Polo Tecnologico Alto Adriatico, Select Friuli Venezia Giulia, YesMilano. NEWS Ahead of opening, Enzene expands scope for biomanufacturing at New Jersey site Enzene, a pioneer in fully-connected continuous biologics manufacturing technology, announced that ahead of the official opening of its biologics manufacturing facility in Hopewell, close to Princeton in New Jersey, it has expanded its plans for the site. Located in the heart of the Northeast’s biopharma corridor, the site will now incorporate a further 26,000 square feet of drug substance manufacturing suites, laboratories, storage, dispensing and warehousing. “We will officially open our site later this year but are already producing non-GMP batches and seeing strong demand from U.S.- based small- and medium-sized innovators as we look ahead to GMP readiness,” commented Norm Stoffregen, SVP and site head at Hopewell. “With construction already well advanced, it made sense to seize the opportunity to add to the 54,000 square feet we had already planned, so that we could include additional capacity, larger dedicated quality control and development laboratories, and the space we will need for materials and finished goods.” As well as conventional fed-batch drug substance manufacturing, the expanded scope of development will make extensive use of the modular EnzeneX™ 2.0 platform, which occupies a smaller footprint than that of conventional systems. The platform, which uses the first fully-connected continuous manufacturing™ (FCCM™) technology, leverages optimized cell media to boost cell productivity and efficiency, while also incorporating process analytical technology (PAT) to enable real-time monitoring and control for consistent quality and optimized processing. It is capable of clinical phase GMP supply from as low as 30-liter scale, with variable bioreactor capacity to accommodate scale-on and scaleout expansion.

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