Maria Elena Guadagno

Maria Elena Guadagno leads the Business Unit Organization, with responsibility of Technical Business Development, Business Management and Technology Transfer departments, she joined BSP Pharmaceuticals in 2008.Maria Elena Guadagno (BSP Pharmaceuticals) discussed ADC manufacturing complexity and facility design. An ADC manufacturing facility requires a combination of both biological manufacturing and highly toxic compound capabilities and expertise.
<> At BSP, manufacturing is performed within classified areas (class C for conjugation activities and class A for fill/finish activities), while facility and equipment design ensure occupational exposure levels below 10 ng/m3. The ADC supply chain is extensive and expensive, generally requiring fine-tuning of multiple vendors and many project management hours to ensure successful project execution. BSP’s fill/finish capabilities currently cover development up to commercial supply for both lyophilized and liquid vials (2 to 100 ml vial size), with the necessary cleaning procedures and analytical capabilities. In the near future, conjugation capabilities will become available to offer conjugation and fill/finish at the same site, thus simplifying the supply chain.