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Aad van de Leur is working at Synthon Biopharmaceutical BV the Netherlands in the position of Chief Operations Officer since 2009. In this role he is responsible for all CMC development, qualification and manufacturing activities from cell line development to Drug Product. Within Synthon he worked on biosimilars and NBEs with a present focus on antibody drug conjugates. Before starting at Synthon he worked for over 23 years at Diosynth and Organon in both upstream, downstream and project management positions.
Adapting biomanufacturing strategies and technologies for next generation therapies
With the introduction of new innovative high potent biopharmaceuticals like Antibody Drug Conjugates (ADCs) the industry had to adapt and move to complete different strategies to produce these products. Next to the standard cGMP requirements additional safety aspects need to be taken into account. In addition, the volumes of these products would be limited resulting in smaller facilities and options to utilize single use materials but also the need to adapt certain equipment. In this talk I will present how Synthon Biopharmaceuticals approached these challenges resulting in in-house manufacturing capabilities.