Interview with Bibra toxicology advice and consulting

Ahead of the upcoming Extractables & Leachables China 2023 conference, we caught up with Chris Waine, the Senior Toxicologist from Bibra toxicology advice and consulting. He gave us a sneak peek of what we can expect from his presentation on day two: 'Health risk assessment of Extractables and Leachables – things are not always what they seem'.
‚ÄčLearn more about what he shared with us below!


1. Hi Chris, it’s great to have you joining us this year! Can you tell us more about your upcoming presentation at E&L Asia 2023?

Hi! Thanks for the opportunity. I’m really looking forward to the event. I’m going to be talking about toxicological risk assessments, and specifically, where there are additional challenges because of uncertainties in the characterisation. This can involve where the leachable came from, how much was actually detected, or even what the identity is!

As a toxicologist, any doubt over the identification can lead to a risk assessment that isn’t accurate. That, in turn, might mean that patients are not adequately protected. So, you can see how it is important to get things right.

2. Why did you choose to tackle this topic?

I’m a strong believer that the most effective toxicological assessments of extractables and leachables come when there is good communication between a client, their analysts and their toxicologists. Each has their own specialism, so each one needs the others’ help to do the best work. From my perspective as a toxicologist, I need to work closely with the analysts to make sure I know exactly what I need to assess.

3. What are the main challenges in your day-to-day work relating to E&L? The recent move to carrying out exhaustive extractions means that, very often, we are presented with very long lists of compounds to assess. To carry out a full health risk assessment on every one would be extremely resource intensive, so the challenge is in identifying the compounds of the highest priority – screening the substances identified so that we can provide a health protective but resource efficient report to our clients.

4. What are you most looking forward to at the event? 

For me, it will be a combination of hearing from old friends from the E&L world, making new connections, and keeping up-to-date with the science. The agenda looks excellent, and I’m really pleased to be in such esteemed company as a speaker. I’m hoping that this presentation will make people think about their E&L assessments in a different way, and I’m looking forward to engaging with the delegates to discuss this with them.