2024: The Year to get serious about E&L data sharing?

Happy New Year from Maven E&L: 2024 the year to get serious about E&L data sharing?

I hope as we enter 2024 you have had a chance to reflect on the year ahead. In 2023, there was much achieved in the world of E&L but as always much still to do. One of the items that was mentioned to me in 2023 was the creation of an issues map for E&L (Thanks go to Andy Teasdale for that thought).

I have been thinking about this a little bit, and at the end of this post is my attempt to do that. As always this is the view only of Maven E&L, I am sure that others would write a different one and please feel free to add or contradict this one.

One of the inputs into this list was the Smither E&L conference in November. As always it is a great opportunity to meet and discuss issues of the day. During that particular conference I posed a few questions for the audience in attendance, and I thought I share them again today as a prologue to my 2024 E&L issues map.

Question 1 was:

What underlining quality system is necessary to conduct an extractable or leachable experiment? I asked this question since I have been frequently surprised that we do not have a clear answer to this question. I have been involved in E&L since 1990’s but we have not yet (it would seem) agreed how and what is the quality system underlying the work. Below is the response from that question (which verified my experience).

Some might argue that question was ambiguous, but that was partially the point.

So on to question 2:

Would you like your extractable analysis to be validated? Apparently this is an ambiguous question! I carefully used a word (validation) which apparently we have still not agreed upon! Some of the No’s come from that choice of word but some come from our inability to decide on what we want to do with our methods (linked to Q1).

Question 3 moves us further into our current issues. We have no agreement what we expect from our methods. More than 25% expect the result to be not accurate and another substantially group expect the result to be accurate. Are they both right?  Would you buy a car or food from the supermarket on the same basis? Surely we can do better to clarify the intent.

Question 4 delves further into the subject.

This result (for me) says several things. Firstly, laboratories are expected to be the heavy lifting here. Are they aware of that? Nearly a third of respondents voted for “reference standards should be based upon a standard document” – but I am pretty sure we don’t have one right now. At least one that everybody can see and see upon, and lastly the “It depends” category is sadly still needed.

Question 5 changes tack slightly. But it really does summarise our current issues. It asks

This is a simple point, do you want your result considered to be a GMP result. The problem here is that extractable analysis has a Jekyll and Hyde character.

People have tried for years to reduce this subject area to a single test – ideally one they can throw over the metaphorical fence to a 3rd party lab, who will spend very little money but will accept responsibility and risk to ensure that they drug product is of high quality and safe. But the reality is that in order to achieve the level of knowledge and understanding to determine if your latest and greatest pharmaceutical meets the basic requirements of safety and quality standards you do need to spend some time and effort to understand the risk from leachables and to do that is a project which will require time and effort and most probably a few analytical methods of high quality be they leachable or extractable.

So, I am glad to see that the majority believe that some oversight is required and it does depend on what you are doing.

So finally, with the prologue behind us. I can open Chapter one of the 2024 E&L story. Below is my E&L issues map, which I and others will be working on during 2024 and beyond. Hope to believe that lots of these can be resolved during the year and look forward to the journey and undiscovered country it represents. My image issues map is posted below and on my Website (available for download as a high-resolution image). You will see that all the major issues are due in part to a lack of shared knowledge. So my New Years resolution will be to try to do something about that.

Happy New Year to clients and colleagues. Chinese New Year 2024, is the year of the Dragon, lets not wait until February to start a fire under E&L!

Jason Creasey, Managing Director Maven E&L.