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Bayer R&D Pharmaceutical Sciences Interview

Practical consideration for cumulative E&L effects from production components

Presentation highlights:

  • How to estimate cumulative effects?
  • What kind of roles cumulative effects have in drug product safety
  • Cumulative effects of PERL compounds in the drug product manufacturing

Ahead of the 2025 Extractables & Leachables Europe conference, we spoke to Tarja Nurmi, Senior Expert, Extractables & Leachables, at Bayer R&D Pharmaceutical Sciences. 

Your 2025 presentation focuses on Practical Considerations for Cumulative E&L Effects. What inspired you to explore this particular topic now?

Health authorities have recently paid a lot of attention to chemical safety of processes. Therefore, this is an E&L topic which the industry is working on at present. I want to share some examples of how the safety of plastic and rubber components in drug production can be assessed.  

As someone actively involved with the ELSIE Consortium, what role do you see ELSIE playing in advancing E&L knowledge and best practices?

ELSIE provides a contact network in which you can reflect your E&L thoughts and get inspired by the solutions other pharma representatives have figured out.

 What are you most looking forward to at this year’s E&L conference? Are there any sessions or topics that particularly interest you?

Definitely it is interesting to hear about ICH Q3E (Parris and Worsoe), alternatives for exhaustive studies would make life easier with medical devices (Alessio Mastrovito), PFAS forever chemicals to get more insight (Margherita Monico) and of course USP 665 separating fact from fiction (Desmond Hunt) to mention some examples. 

Was there something you learned or took away from last year’s event that has influenced your work since?

I finally decided that I will try to get a high-resolution mass spectrometer also for our GC. PFAS presentation inspired me to have a closer look to that compound group and consider those in more detailed from E&L perspective.