BSP Pharmaceuticals

Overview

BSP Pharmaceuticals S.p.a. is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end pharmaceutical services for oncological and non-cytotoxic innovative drugs. The company operates two segregated facilities designed to handle development from pre-clinical GLP to cGMP manufacturing for clinical and commercial supply.

Capabilities

Manufacturing Scope:

• Cytotoxic and high-potent oncology drugs (OEL < 0.01 µG/M³) and non-cytotoxic compounds (up to OEB 6)
• Small and large molecules including ADCs (conjugation and fill finish), peptides, proteins, oligonucleotides, and nano medicines
• Lipid-based formulations (nano and micro-emulsions, liposomal formulations)
• Proteasome inhibitors and immunotherapy compounds

Development Services:

• Preformulation studies, dosage form selection, and compatibility studies
• Cleanability studies and stability testing
• Formulation, process optimization, and scale-up
• Analytical method development and validation

Clinical & Commercial Supply:

• Phase I through Phase III clinical manufacturing
• Conventional dosage forms (lyophilized vials, liquid-filled vials, tablets, capsules)
• Advanced formats including liquid-filled hard gelatin capsules and ADC products

Quality & Regulatory:

• QC laboratories equipped for chemical, biochemical, and microbiological testing
• Raw material, in-process, release, and stability testing
• Internal regulatory affairs team for DMF and CMC documentation
• Global regulatory support and import/export management

Differentiation

• High containment and explosion-proof manufacturing facilities with 100% one-pass air handling systems
• Integrated ADC services (conjugation and fill finish at same site)
• State-of-the-art lipid-based formulation technology
• Experience with breakthrough, emergency use, and fast-track designated products
• Supply to over 80 countries (EU, US, JP)
• Life cycle management with process and product improvement focus