End-to-End Single-Use Manufacturing at Pilot Plant for Early Development Clinical Material

The single-use item within the pharmaceutical industry is becoming more and more popular. What is it about running an end-to-end, single-use facility? What challenges does it bring with it and what opportunities? How can we make sure that we create this safe environment to have an open dialogue between the pharmaceutical industry and the supplier?

Presented by Agnieszka Önder, DS Operations Pilot Plant Leiden at The Janssen Pharmaceutical Companies of Johnson & Johnson

Agnieszka is a pharma supply chain professional. She started her career working as a bioprocess engineer on the development of adeno-based HIV and TB vaccines. From there, she moved to the Commercial Unit at Janssen, where she gained knowledge on the large-molecule-based platform. As part of the Janssen personal development program, she had a chance to experience the clinical supply chain and was able to transfer the product from R&D to commercial space. Later on, as the Reliability Lead for the Small Molecule platform, she introduced performance management at all levels of the organization in Beerse, Belgium; Xian, China; Fiji, Japan; and HyangNam, South Korea. As the next step in her career, she joined the Global Reliability Department where she had to lead global projects where she was able to bring the Janssen organization to the next level of digitalization by introducing dashboards and processes to support business trade-off decisions. In her latest role, she has been back in the manufacturing environment, where she created and established an Early Development New Product Pilot Plant team in Leiden that grew 10 times in one year.