Latina, Italy – 1 October, 2020 – BSP Pharmaceuticals, a CDMO focused on the manufacturing of Anticancer and innovative drugs, has received regulatory authorization from AIFA (Italian Medicines Agency) for the activation of new injectable filling lines.
With two separate inspections conducted in February and September 2020, the Agency has authorized respectively Sterile 5 and Sterile 6 and released these new areas to manufacture.
The additional two aseptic filling lines, will add full contained capacity for liquid and lyophilized vials
With these further implementation, full contained capacity for liquid and lyophilized vials will be increased to 22,0 million unit per year.
“The worldwide Oncology market is experiencing an increasing demand of capacity to fulfill continuously growing needs coming from the patients and to produce under the highest level of quality requirements” commented Aldo Braca, President & CEO. “BSP will empower its support to innovators, to meet their needs and to ensure continuity of the supply, without exposing them to inconvenient situations”
BSP Pharmaceuticals is a CDMO providing development, manufacturing and analytical services for innovative small and large molecules.
Capabilities can cover a wide range of batch sizes providing flexibility to sustain preclinical, clinical and commercial manufacturing.
Operating a world class technology, BSP can offer full contained technology to manage High Potent APIs with OEL up to < 10ng/m3 and suitable for Biologics including mAbs, ADCs, synthetic peptides for Oncology and Non-Oncology therapies.
New expansion will also open capacity to handle IMMUNO-ONCOLOGY drugs (mAbs, checkpoint inhibitors, synthetic vaccines), IMMUNOTHERAPY drugs, as well as other INNOVATIVE products with the objective to continue supporting innovators in a wide range of therapeutic indications.
BSP Pharmaceuticals is located in Latina, Italy.
For more information, visit http://www.bsppharmaceuticals.com/