From DCAT Week 2023: BSP Pharmaceuticals Details $349-M Expansion Plan 

BSP Pharmaceuticals, a Latina, Italy-based CDMO of cytotoxic and non-cytotoxic products, is investing EUR 320 million ($349 million) to expand its site in Latina, Italy, with the expansions slated for full operation by the end of 2025. Anna Maria Braca, General Counsel and Vice President, Strategic Business Development, BSP Pharmaceuticals, provided an update of the company’s expansion plans at the DCAT Member Company Announcement Forum held on March 20, 2023, at DCAT Week.  

Anna Maria Braca,
General Counsel & Vice President, Strategic Business Development,
BSP Pharmaceuticals

The mid-term strategic plan was approved by the company in December 2022 and will expand capacity for antibody drug conjugates (ADCs) and non-conventional formulations, such as lipid-based nano medicines, as well as for peptides, and proteins in the oncology, the immuno-oncology, and immunotherapy fields. 

The new cycle of investment will include: one additional conjugation suite of 6,500 g/batch at monoclonal antibody (mAb) scale; a new sterile suite in full containment for sterile liquid and lyo vials; and a new building with a footprint of approximately 22,000 square feet for further expansion for the manufacturing of cytotoxic compounds.  

Three additional sterile suites in full containment are planned to be built for the manufacturing of sterile liquid vials (non-cytotoxic projects) for biologicals and small molecules for immuno-oncology and immunotherapy projects. 

Furthermore, BSP is adding a new warehouse to support the growth of its business and to increase cold-chain capacity for biologics with the installation of additional refrigerated and deep-frozen storage. The company is also completing an expansion of chemical, biochemical, and microbiological laboratories, which includes increased capacity and new technologies in which the company is involved, such as new RNA-based therapeutics, new ADCs, next-generation peptides, and liposomal formulations. 

Upon completion of the company’s first cycle of investment by the end of 2025, BSP will have capacity up to approximately 1,250 kg mAb/year for the manufacturing of BDS, 49 million injectable units/year for cytotoxic drug products, and 61 million injectable units/year for non-cytotoxic drug products. The capacity for temperature-controlled storage will be 10,500 pallet places at room temperature, 3,300 pallet places at 2-8 °C, 680 freezers at -20/-80 °C, and four walking rooms at -20/-25/-40 °C.