BSP Pharmaceuticals
BSP Pharmaceuticals S.p.A. is a Contract Development and Manufacturing Organization (CDMO) specializing in end-to-end pharmaceutical services for oncological and non-cytotoxic innovative drugs. The company operates two segregated facilities capable of supporting the entire product lifecycle, from pre-clinical development to cGMP manufacturing for clinical and commercial supply. It offers advanced technologies and integrated services including development, clinical, and commercial supply of cytotoxic, ADCs, and non-cytotoxic drugs, with a focus on high containment, sustainability, and global regulatory support.
Industries
Nr. of Employees
Very Large (1000+)
BSP Pharmaceuticals
Products
Development Contract — regional R&D project for oncological biopharma
Regional and EU co‑funded project to develop and manufacture oncological biopharma candidates for clinical trials.
Development Contract — regional R&D project for oncological biopharma
Regional and EU co‑funded project to develop and manufacture oncological biopharma candidates for clinical trials.
Services
Preformulation, dosage form selection, compatibility and cleanability studies, stability testing, formulation optimization and scale‑up/scale‑down support; supports solvent‑based and lipid‑based formulations and both small and large molecules.
Manufacturing services for clinical trial supply across phases I–III with flexible scale‑up/scale‑down and automated equipment compatibility.
Commercial production of sterile injectables and oral solids with secondary packaging services and global distribution support; includes multiple sterile suites, dedicated cold storage and secondary packaging capability for commercial supply.
Conjugation suites and sterile fill–finish for ADC programmes, supporting development through commercial launch within the same facility and quality system.
Analytical method transfer and validation, release and stability testing, environmental monitoring, bioburden, sterility and endotoxin testing and validated bioassays suitable for regulatory submissions.
Internal regulatory team providing data collection and preparation of regulatory documents such as DMF and CMC to support filings and regulatory interactions.
Preformulation, dosage form selection, compatibility and cleanability studies, stability testing, formulation optimization and scale‑up/scale‑down support; supports solvent‑based and lipid‑based formulations and both small and large molecules.
Manufacturing services for clinical trial supply across phases I–III with flexible scale‑up/scale‑down and automated equipment compatibility.
Commercial production of sterile injectables and oral solids with secondary packaging services and global distribution support; includes multiple sterile suites, dedicated cold storage and secondary packaging capability for commercial supply.
Conjugation suites and sterile fill–finish for ADC programmes, supporting development through commercial launch within the same facility and quality system.
Analytical method transfer and validation, release and stability testing, environmental monitoring, bioburden, sterility and endotoxin testing and validated bioassays suitable for regulatory submissions.
Internal regulatory team providing data collection and preparation of regulatory documents such as DMF and CMC to support filings and regulatory interactions.
Expertise Areas
- Highly potent and cytotoxic compound CDMO services
- ADC conjugation and integrated drug product manufacturing
- Sterile injectable and lyophilized product manufacturing for oncology and non‑oncology indications
- Formulation development for lipid‑based systems and nanomedicines
Key Technologies
- Isolators and barrier systems (cRABS)
- Tangential flow filtration (TFF) / diafiltration
- Preparative and analytical chromatography
- Cryogenic lyophilization
News & Updates
Development and manufacturing of new oncological biopharma drugs for clinical trials, supported by €3,381,550 funding.
Participation in the upcoming BIO International Convention in Boston, MA, USA, from June 16-19, 2025.
Participation in the ADC summit in Incheon, South Korea, from June 10-12, 2025.
Participation in the CPHI North America event in Philadelphia, PA, USA, from May 20-22, 2025.
Participation in the CDMO Live event at the World Trade Center in Rotterdam, Netherlands, from May 7-8, 2025.
Recognized for supporting the development and supply of ADCs, including conjugation and fill-finish, with a global reach of over 80 countries.
Development and manufacturing of new oncological biopharma drugs for clinical trials, supported by €3,381,550 funding.
Participation in the upcoming BIO International Convention in Boston, MA, USA, from June 16-19, 2025.
Participation in the ADC summit in Incheon, South Korea, from June 10-12, 2025.
Participation in the CPHI North America event in Philadelphia, PA, USA, from May 20-22, 2025.
Participation in the CDMO Live event at the World Trade Center in Rotterdam, Netherlands, from May 7-8, 2025.
Recognized for supporting the development and supply of ADCs, including conjugation and fill-finish, with a global reach of over 80 countries.