BSP To Add High-Containment Capacity for Conjugation and Injectable Drug Products
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Aldo Braca |
BSP Pharmaceuticals, a Latina Scalo, Italy-based contract development and manufacturing organization of oral solid dosage forms and injectables, is expanding high-containment capacity dedicated to oncology compounds and adding new capacity for innovative molecules and immunotherapies. Giorgio Salciarini, Technical Business Development Manager, BSP Pharmaceuticals, on behalf of Aldo Braca, President and CEO, BSP Pharmaceuticals, outlined the investments at the DCAT Week ’19 Member Company Announcement Forum, which was held March 18, 2019 in New York.
BSP is expanding existing facilities for oncology products and cytotoxics by approximately 30,000 square feet to increase its total conjugation capacity of antibody drug conjugates (ADCs) to 200 kilograms of monoclonal antibodies per annum. The company is also expanding injectable drug-product capacity by 25% through the addition of 5 million lyophilized vials to its current capacity of 20 million lyophilized vials per annum. The investments are part of a strategy to provide a full package of services from development to commercial scales by offering all the intermediates steps for pre-clinicals trials (GLP) and clinical trials (GMP) for both liquid and lyophilized vials.
The company is also adding new capacity to support production of immunotherapies. The company has completed the construction of two new buildings with a footprint of approximately 150,000 square feet to allow for up to five GMP suites to manufacture injectable drug products and to include approximately 30,000 square feet to generate the utilities needed to feed the new plant.
The company also acquired an additional building next to its existing campus to house a new development laboratory with additional capacity for analytical, formulation and process development for conjugation and drug products (injectables and oral solids), new areas for visual inspection and warehousing, and new quality control labs (chemical, biochemical, and microbiological) to duplicate its current quality-control labs.
The new capacities will be available by the end of 2020.