BSP Pharmaceuticals is advancing a major expansion of its manufacturing capacity, as part of a revised mid- to long-term strategic plan, designed to support growing global demand for complex biologics and advanced therapeutics. The investment program, approved by the company’s Board of Directors in 2025, accelerates previously planned development at the company’s integrated campus in Latina, Italy. Anna Maria Braca, General Counsel & Vice President, Strategic Business Development, BSP Pharmaceuticals, provided an update of the company’s investment plan at the DCAT Member Company Announcement Forum, held March 23, 2026, at DCAT Week.

The expansion plan is structured in two phases. The company estimates that the first wave represents an investment of approximately EUR 200 million ($234 million), with an additional EUR 500 million ($586 million) allocated for the second wave through 2030.

The first phase focuses on bringing new manufacturing capacity online by the end of 2026. The first wave includes significant investments in both drug-substance and drug-product manufacturing. In the company’s cytotoxic manufacturing area, two additional conjugation lines will be completed to complement five existing suites. These new lines will support different antibody drug conjugate (ADC) scales, with capacity reaching up to approximately 4,500 grams per batch for one line and more than 15,000 grams per batch for the other. The expansion is designed to support the production of ADCs and other highly potent bioconjugates.

In parallel, a new manufacturing building is being constructed to accommodate an additional fully contained drug-product line capable of producing both sterile liquid and lyophilized formulations. This line will add more than six million vial units per year to the company’s fill–finish capacity. The investment also includes a non-cytotoxic manufacturing area with two new sterile suites designed for sterile vial production.

Upon completion of the first wave, BSP expects its drug-substance manufacturing capacity to increase from approximately 1,700 kilograms per year to more than 2,700 kilograms annually, representing an increase of roughly 60%. Drug-product capacity for non-cytotoxic vials is projected to expand from approximately 38 million units per year to more than 52 million units annually.

The second phase of the program will further expand capacity between 2027 and 2030. Planned additions include two additional conjugation suites for cytotoxic manufacturing and three new sterile suites dedicated to cytotoxic drug-product manufacturing. Another sterile suite will be added for non-cytotoxic drug-product production, with additional space reserved for future expansion if needed.

When fully completed, the expanded infrastructure is expected to raise BSP’s drug-substance manufacturing capacity to more than 4,000 kilograms per year. Drug-product capacity will also increase significantly, reaching approximately 61 million cytotoxic vials per year and more than 103 million non-cytotoxic vials annually.

Overall, the expansion is designed to strengthen the company’s position specializing in highly potent compounds, biologics, and next-generation therapeutic modalities. The additional infrastructure will support sterile liquid and lyophilized vial manufacturing for biologics and innovative small-molecule therapies, including RNA-based oncology vaccines, polypeptide and peptide therapeutics, and other emerging modalities.