Nelson Labs is pleased to sponsor and participate with our sister company Sterigenics at this year’s Drug-Device Combination Products Summit in Amsterdam, The Netherlands 23 – 24 September. The important event unites drug delivery pioneers and device engineers to shape the future of combination products.
Our team members will be onsite to discuss patient-centric innovation, smart technologies, and regulatory alignment are transforming development, while addressing the industry’s responsibility for safety, usability, and environmental impact.
Click here for more information on the 8th Annual Drug-Device Combination Products Summit organized by Etapa Pharma.
Check down below for details on our presentation by Pieter Van Wouwe, PhD.
Join our presentation
Title: Extractables & Leachables considerations in combination products
Date/Time: Day 1: 23 September – 12:40pm
Presenter: Pieter Van Wouwe, PhD, E&L Expert, Nelson Labs
Abstract:
In combination products, impurities may be released from the different polymeric components (extractables) used in these systems and may end up (via the drug product) in the patient (leachables). Hence, these compounds may pose a safety risk and/or quality risk, which makes the assessment of extractables and leachables essential in the qualification process. In this presentation, an overview of different types of combination products will be given. The regulatory landscape and relevant guidelines with respect to extractables/leachables will be reviewed for both EU and US markets. Moreover, an overview of parameters which drive the leaching process will be discussed as well as an overview of critical parameters which need to be taken into account in the design of these analytical studies. Specific case studies will provide practical examples of the different aspects needed in these analytical studies.
Check down below for details on the participation on the panel discussion with Pieter Van Wouwe, PhD.
Join the panel discussion
Title: What will the PFS / device of tomorrow look like for large-volume biologics?
Date/Time: Day 1: 23 September – 17:20pm
Panelists:
Dr. Shrenik Mehta, Genentech
Dr. Bettine Boltres, West Pharmaceutical Services Deutsch/and GmbH&CoKG
Dr. Satish Singh, Astria Therapeutics, A Biocryst Company
Dr. Tieming Ruan, Parabilis Medicines
Dr. Jakob Lange, Ypsomed AG
Dr. Pieter Van Wouwe, Nelson Labs
Katharina Golly, Novartis
Abstract:
As therapies evolve, so do the demands on drug delivery.
The next generation of prefilled syringes and devices must go far beyond today’s standards – balancing patient experience, formulation constraints, and manufacturing realities.
At the upcoming discussions, key questions take center stage:
Volume & Delivery
How far can we push injection volumes while maintaining comfort and adherence? Where is the shift between traditional PFS and on-body delivery systems?
Injection Time & Patient Experience
What are acceptable injection durations for high-volume biologics – and how can device design optimize usability outside clinical settings?
Container-Drug Interactions
How do materials impact biologic stability? What are the risks around leachables, extractables, and long-term compatibility?
Glass vs Plastic – What’s Next?
Will advanced polymers replace glass? Or will hybrid solutions define the future of PFS systems?
Device Innovation
From wearable injectors to smart delivery systems – how technology is enabling safer, more precise, and patient-friendly administration The future of large-volume biologics delivery is being shaped now – through the intersection of science, engineering, and real-world patient needs.
Pieter Van Wouwe
Scientific expert
Pieter Van Wouwe received his Master’s degree and PhD in Bioscience Engineering at the University of Leuven in 2011. In March 2016, he started working at Nelson Labs as a project manager, initially mainly involved in scientific interpretations and the reporting of analytical results. Over the years, he has expanded his role and became responsible for designing pharma-related extractable and leachable studies for both packaging materials and process materials. More recently, he has broadened his expertise to include medical devices and combination devices. Providing support for extractables and leachables studies to both biopharmaceutical and medical device companies is one of his current focus points, while knowledge sharing - internally and externally - is also part of his current role at Nelson Labs.
