BSP Pharmaceuticals

Overview

BSP Pharmaceuticals S.p.a. is a Contract Development and Manufacturing Organization (CDMO) focused on end-to-end pharmaceutical services for oncological and non-cytotoxic innovative drugs. The company operates two segregated facilities designed to handle both small and large molecules, supporting the complete product lifecycle from pre-clinical GLP through cGMP manufacturing for clinical and commercial supply.

Capabilities

Development Services

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

Manufacturing Expertise

• Cytotoxic and high-potency oncology drugs (OEL < 0.01 µG/M³) and non-cytotoxic compounds (up to OEB 6)
• ADCs with integrated conjugation and fill-finish services at the same site
• Peptides, proteins, and oligonucleotides
• Lipid-based formulations (nano and micro-emulsions, liposomal formulations)
• Conventional dosage forms: lyophilized vials, liquid-filled vials with aseptic filling, tablets, capsules
• Advanced formats: liquid-filled hard gelatin capsules

Clinical & Commercial Supply

• Phase I through Phase III clinical manufacturing
• Commercial supply with process robustness and technology transfer expertise
• Versatile plants enabling scale-up and scale-down on automated equipment

Quality & Regulatory

• QC laboratories equipped for chemical, biochemical, and microbiological testing
• Raw material, in-process control, release, and stability testing
• Internal Regulatory Affairs team for DMF and CMC data collection and document preparation
• Global regulatory support and import/export management

Differentiation

• High-containment and explosion-proof manufacturing facilities with 100% one-pass-through air handling systems
• State-of-the-art lipid-based formulation technology for temperature, light, and oxygen-sensitive products
• Experience with breakthrough, emergency use, and fast-track designated products
• Supply to over 80 countries (EU, US, JP)
• Integrated development labs co-located with production areas to reduce scale-up risk
• Focus on sustainability and lifecycle management with continuous process and product improvement