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Podcasts

Tackling Combination Products’ Complexity and Testing Challenges

In this episode of the Pharma Matters podcast, host Patrick Lavery speaks with Martell Winters, Senior Manager, Scientific Business Development, and Pieter Van Wouwe, Scientific Expert, both at Nelson Labs about the rise in popularity of combination products. The discussion looks at where sponsors run into problems in the testing process, concerns about factors like sterility, microbiology, and E&L, and the trends that may shape the coming years.

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Martell Winters

Martell Winters

RM/SM (NRCM), CISS-RAD
Sr. Manager, Scientific Business Development

Martell Winters is a specialist microbiologist (NRCM) and a radiation specialist (AAMI). He has been at Nelson Labs for 24 years and spent his earlier years working in the Radiation Sterilization group, responsible for bioburden testing and radiation validation studies. His specialties include microbiological process validation and radiation sterilization of medical devices, allograft tissue, and pharmaceutical products.

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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.