BSP Pharmaceuticals S.p.A. is a Contract Development Manufacturing Organization focused on development, clinical and commercial production and fully dedicated to anticancer products, without any potency limitation.
BSP has a manufacturing plant located close to Rome, in Latina Scalo (LT), Italy and a commercial branch in Princeton, NJ (USA).
Since 2008, the plant has been approved by all the regulatory authorities, including without limitation EMA, FDA, PDMA Japan and ANVISA and is currently serving more than 70 countries. Our services can cover from the early development up to the commercial manufacturing, applying the most advanced and safe technologies, in compliance with the highest quality product delivery.
In addition to the manufacturing of more conventional small molecules, our facility is designed to handle ADC compounds from Conjugation to fill/finish and very much focused on other innovative therapies.
The plant is a high containment manufacturing facility designed to achieve an Occupational Exposure Limit (OEL): <10 nanograms/m3.
Our production area includes four sterile manufacturing suites (approximately 1300 ft² freeze drying surface in total); an oral department, for solid formulation (tablets, Capsules, Liquid filled hard gelatin capsules); BDS suites for liposomal solution and conjugation of ADC products; two development laboratories and integrated quality control laboratories.
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