Kedrion today welcomed Member of the European Parliament Dario Nardella to its plant in Bolognana (Lucca, Italy), where the company recently announced an investment of approximately €150 million, supported by of the Ministry of Enterprises and Made in Italy (MIMIT), to triple the production capacity from 1.1 million to 3.3 million liters of plasma processed per year. Bolognana has become the cornerstone of Italy’s “Plasma Valley” that plays a strategic role within the global plasma‑derived therapies value chain.
The visit included a presentation of the company’s activities and the production site, followed by a guided tour of the facility, providing an opportunity to gain first-hand insight into Kedrion’s leading role in the development of therapies for patients with rare and ultra-rare diseases.
Significant attention was devoted to the European regulatory landscape, with a focus on key legislative initiatives currently under development affecting the pharmaceutical sector and, more specifically, the plasma-derived medicines industry. Among these, particular emphasis was placed on the Biotech Act, a European initiative aimed at strengthening the competitiveness and manufacturing capacity of the biotech sector within the European Union. On these topics, Kedrion maintains an ongoing dialogue with European institutions, also through its collaboration with PPTA (Plasma Protein Therapeutics Association), with the shared goal of ensuring that the specificities of the plasma value chain are adequately represented in the future regulatory framework.
Dario Nardella, Member of the European Parliament, stated: “Kedrion represents an excellence not only in Tuscany but across Europe in the biopharmaceutical and plasma-derived medicines sector — a top-tier manufacturing reality in the heart of the Garfagnana region. My visit is part of the assessment work I am carrying out across leading Italian manufacturing sites, in view of the upcoming vote on the European regulation on biotechnologies, for which I serve as rapporteur for the S&D Group in the European Parliament. Regulations must reflect the reality of local territories: for this reason, I am gathering valuable insights, experiences, and testimonials across the entire production network of the sector, with a particular focus on pharmaceuticals and on Tuscany’s strong vocation in this field. With the new European regulation, we will achieve greater simplification, enhanced competitiveness, and more tools — both financial and legislative — to support biotechnology companies and to close, within a relatively short timeframe, the significant gap that currently separates Europe from the global leadership of the United States. The deadline for submitting amendments to the European Commission’s proposal is July 7. I am confident that the entire Parliament will deliver innovative and bold work, leading to an ambitious final text that will drive significant progress for the entire Italian and European biotechnology industry.”
“This visit represented an important opportunity for discussion on the strategic role of plasma and the plasma-derived medicines industry. We addressed key challenges and opportunities at the European level, with the aim of contributing to strengthening the continent’s strategic autonomy and its global competitiveness. We believe that moments like this can help increase the attention of European institutions toward this sector and its role in serving patients, ultimately supporting availability, manufacturing capacity, and continuity of supply”, commented Paolo Marcucci, Chairman at Kedrion.
Marilena Vrana, Vice President of Public Affairs and EU Operations at PPTA, added:
“Today’s visit was an important opportunity to bring policymakers closer to the realities of plasma-derived medicines and to the companies that make them possible. Seeing the production process first-hand underlines the importance of plasma as an irreplaceable starting material, as well as the complexity, expertise and long-term investment needed to turn it into lifesaving critical medicines. As the Biotech Act takes shape, it should provide a future-proof framework that supports resilient biomanufacturing across the full value chain and helps companies scale innovations in Europe.”
The visit is part of the ongoing dialogue that Kedrion and PPTA foster with institutions to support the development of the biotech sector and enhance the strategic contribution of the plasma-derived therapies value chain.
