Obtained a PhD in metal-mediated organic synthesis from Utrecht University in 1997 and started his industrial career in Process Development and Commercialization of small molecule API’s. Rob headed a chemical pilot plant and has been Director Process R&D on Steroids & Heterocyclic molecules. After two years in Biotech (upstream and downstream processing), he worked for six years as Director Operations in a commercial sterile Fill & Finish plant. He joined Ardena in 2018, initially as Director Process R&D & Manufacturing and in 2020 he transitioned into the role of Business Unit Director of Ardena Oss. In July 2022 he was appointed CHEM Division Manager of Ardena. In his current role, Rob is responsible for Ardena’s drug substance activities at the sites in Oss (The Netherlands) and Sodertalje (Sweden). Rob brings experience in working with API’s in highly potent DS and DP facilities.

Presentation Title: Process Development and Commercialization of Highly Potent APIs

Abstract: Process development, commercialization and manufacturing of highly potent API’s presents significant challenges but it also represents a major opportunity for biotech companies looking to bring new treatments to patients. However, handling these HPAPI’s requires expertise, specific equipment and organizational and technical measures to ensure control of occupational exposure and to avoid cross-contamination to ensure operator safety as well as
patient safety.
This presentation aims to provide a comprehensive overview of the best
practices applied at Ardena, offering pharmaceutical companies effective control strategies to ensure safe HPAPI process development, commercialization and manufacturing.

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