BSP Pharmaceuticals
One-Stop-Shop for Oncological and Non - Cytotoxic innovative Drugs

Access to medicines for cancer patients is crucial for providing high-quality care. However, medicines shortages were more commonplace in the last decade. Oncology medicines were most frequently affected by shortages, primarily due to manufacturing and distribution issues. Cancer medicines shortages could be particularly challenging due to the impact on individual cancer patients' outcomes. In response to the worldwide lack of qualified capacity experienced by the pharma industry in the previous years, Italy-based BSP Pharmaceuticals entered the space of CDMOs. They selectively positioned their services differently from the rest of the competition by designing a facility that works in full containment with the proper technology level to handle high potent APIs. The firm covers the entire life cycle of a product, from development to clinical trials up to commercialization and providing enough flexibility to fulfill the requirements and needs of small biotech companies and big pharma enterprises.

BSP Pharmaceuticals was founded in 2006 with the strategic vision to provide specialized, world-class technology dedicated explicitly to Oncology therapies. After regulatory approval in 2008 and consolidating operations, the company continued to expand capacities and capabilities by investing in new technology to support the manufacturing of small and large molecules, with specific attention to the class of ADCs. With 850 employees, more than 250 products successfully transferred and distributed in more than 70 countries worldwide, BSP is recognized as one of the leading players in ADCs and other large molecules and a consistent and reliable partner for innovators.

"Since our inception, we have been at the forefront in the fight against cancer, and innovation is our hallmark," states Aldo Braca, founder and CEO of BSP Pharmaceuticals. The company is focused on the development and manufacturing of anticancer drugs with high potency and cytotoxic characteristics. It is engaged in producing small molecule products, proteasome inhibitors, nano and micro-emulsions, and liposomal formulations. The company's manufacturing capabilities support oral dosage forms and injectable liquid. The firm has installed specific technology to produce non-conventional formulations like lipid-based nanomedicine and perform conjugation of monoclonal antibodies with high potent payloads.

For ADCs class of compounds, BSP Pharmaceuticals has developed an integrated system that combines the two main manufacturing steps in one site and provides a beneficial solution to simplify the complex supply chain present previously. The manufacturing facility is integrated with QC labs capabilities (for chemical, biological, and bioanalytical testing) and regulatory support through a reliable QA&C system that assures compliance to international regulatory agencies' highest requirements.

We have been at the forefront in the fight against cancer, and innovation is our hallmark

The scientific expertise and technical skills combined with the flexibility to cater to the small clinical needs to rising market or evolving partners' demands promptly have created a name for BSP Pharmaceuticals in the industry. For instance, in 2015, BSP Pharmaceuticals worked on an ADC program from the early stages of clinical trials to the market's final approval. It began on-site manufacturing of an ADC to support early-stage clinical studies for triple-negative breast cancer. For four years, the company supported the process and formulation optimization and characterization to demonstrate process robustness. BSP Pharmaceuticals scaled up the batch size to sustain the increased demand for the product during the clinical phase and drove the development to PPQs to support its approval. The firm received and successfully closed regulatory inspection for final approval of the product for the market.

Forging ahead, BSP Pharmaceuticals will continue to consolidate its already established position in the oncology space. The firm is expanding its capacity for DP and DS through two new conjugation suites available in 2021 and 2022. Moreover, the firm supports complex and integrated pipelines by extending involvement in other therapeutic areas besides oncology. A new facility will be dedicated to the manufacturing of non-cytotoxic compounds for treating CNS and autoimmune diseases and other innovative compounds for important therapeutic areas.

The Strategic Plan initiated in 2018 is mainly based on the mission to support complex and integrated portfolio of products, where significant manufacturing capacity, world-class-technology and full compliance to highest quality standards are rerquested to support growing needs of patients, new modalities of action and research of new effective therapies.

BSP is ever ready to support its clients' growth by providing development, clinical, and commercial supply services with the same flexibility and reliability through a strategic partnership. The company promises to meet customer's needs without exposing them to inconvenient situations while maintaining a solid financial position that never compromises business continuity and paying great attention to the environment, health, and safety.