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E&L USA 2023 Speaker Carsten Worsoe, Novo Nordisk, to Discuss SUS from Suppliers Without Extraction Data




For 15 years Extractables and Leachables USA 2023 has featured presentations designed to engage and inform the industry while exploring the latest technologies, emerging applications, and new opportunities.

Speakers at the 2023 event includes experts from The FDA, Triad, Nelson Labs, SafeBridge Consultants, Novo Nordisk, ELSIE, SGS Lhasa Limited, WuXi AppTec, VR Analytics, Sartorius Stedim Biotech, Intertek, Instem, PPD, GSK, Solvias, and more.

In presentation The Single Use Dilemma - a case study Carsten Wors√łe, Principal Scientist Extractables and Leachables, CMC Analytical Support, at Novo Nordisk, will discuss the dilemma of using SUS from suppliers without extraction data or knowledge on E&L, featuring a case where a SUS component for a new drug product filling setup was to be implemented and since supplier extraction data was unavailable, an in-house extraction study was carried out.

According to Carsten, "I hope the presentation will give representatives for pharma and suppliers of production systems an insight in the value of supplier extraction data in the qualification of production systems. The case will further present the challenge and process for identification of leachables above an acceptance criteria when no extractables data are available from suppliers."

Carsten has been involved with Smithers E&L conferences for a number of years as an advisory board member and this year as a presenter.

On why he enjoys working with the Smithers E&L Conferences, Carsten noted: "[The Smithers E&L Events have] historically been the events with the largest group of pharma and medical device scientists, suppliers as well as service and analytical equipment providers. This has made it an excellent place to discuss possibilities, interfaces and challenges within E&L."

As a non-toxicologist Carsten is looking forward to discussing a current industry hot topic: how to set data driven toxicological acceptance criteria for different toxicological endpoints in order to facilitate leachables acceptance criteria setting in pharmaceutical drug products. 

Addirional presentations and discussions of interest include medical device chemical characterization process, and the ISO 10993 part 18 maturation and how the ISO 10993 part 17 will facilitate acceptance criteria setting for acceptable levesl of extraction/migration in relation to the studies described in part 18.

Meet Carsten this May 17-18, 2023, in Arlington, VA ! Register for Extractables and Leachables USA 2023 today to hear the latest industry developments and network at included lunches, networking breaks, and an evening reception.