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Novo Nordisk on leachables in drug products

Ahead of his presentation at Extractables & Leachables USA 2017, we spoke to Carsten Worsøe, Prinicipal Scientist Extractables & Leachables at Novo Nordisk about interactions between leachables and pharmaceutical drug products, critical issues surrounding this and more.

What do you think are the most critical issues with leachables ending up in drug products?

In my opinion, there are two equally important issues - the safety of the leachable and the interaction of the leachable with the active ingredient and formulation components having the potential to alter the drug product quality and actions of the drug. The presentation I will give at E&L USA will describe the relative few examples of interactions between leachables and active ingredient and formulation components within drug products that has been reported and presented. 

Why are such interactions not widely reported and presented?

This is actually a difficult question. My best guess would be that it is more difficult to investigate such interactive chemistry compared to standard extractable and leachable testing. Often interactions are observed within biological drug products. In order to observe and document the interaction, leachable and drug product stability testing and characterisation needs to be performed in combination. Many pharmaceutical companies will outsource the extractable and leachable documentation to often highly specialised contract laboratories have the expertise to combine capacities within E&L testing with drug product stability and testing.

Your presentation will discuss an interaction case study that you have investigated - could you tell us a bit more about it?

I will present a case study of a common antioxidant often observed as both an extractable and leachable from polymeric materials and its interaction with a biological system. The study was performed using LC-MS analysis including accurated mass determination. The reaction mechanism for this interaction will be described and likewise general interaction chemistry reaction with biologics will be proposed within the presentation.

What are you most looking forward to at E&L USA 2017?

I think the program for this year's E&L USA looks very interesting, with a sound mix of relevant areas such as the regulatory landscape for E&L's, materials suppliers perspectives, process equipment, toxicology, analytical chemistry and more. Within the E&L landscape, I look forward to hearing news on the USP chapters as well as the almost final parenteral and opthalmics (PODP) recommendations from the PQRI group. It is my understanding that biological interactions and the use of simulated studies for parenterals are the last parts to be finished before publication of the PODP recommendations. I also look forward to the co-presentations between pharmaceutical companies/CROs/analytical equipment suppliers around the advances in analytical equipment for the analysis of E&Ls including the use of accurated mass spectrometry and data process handling being an area which I see as having rapid development at the moment.

Carsten will be presenting as part of the 'Advances in Science' session at E&L USA 2017 this May alongside representatives from Boehringer Ingelheim, Toray Research Center and Aspen Research Corporation.

You can view the full programme here.

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