Ahead of the upcoming Extractables & Leachables China 2021 conference, we caught up with Xiaoxia Ye, Senior Analytical Researcher at Huadong Medicine. She gave us a sneak peek of what we can expect from her presentation on day one, taking place during our 'Perspectives from Pharma and Biotech Companies' session.
Current Industry Focus:
Q. What are the biggest challenges facing the E&L sector (in China)?
For the regulatory agencies and MAH holders, the biggest challenge facing the E&L sector is how to maintain a good balance between product safety, research quality and costs. And secondly, how to promote and implement the "best practices" for E&L.
Q. What are the biggest priorities for medical device and pharmaceutical companies when it comes to E&L studies?
How to reasonably conduct risk assessment and execute experiments at different extent accordingly to mitigate risk(s).
Q. What technical issues to you think still need to be addressed in the future?
The contribution of the leachables from CCS to the impurity profile of the drug products.
Q. How do you think the future regulatory landscape will impact E&L studies in China?
I’m optimistic. Chinese regulator has been publishing technical guidelines at a very fast pace. With more and more data collected, these technical guidelines will be polished in a more scientific way.
Q. Your presentation at E&L China this year is titled “Impurity profiling of drug products-impact from container closure system”. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
In most cases, E&L risk is assessed based on the toxicological data of the extractables and leachables. But for many drugs, the leachables may affect the impurity profile or properties of the drug products. The FDA has published many related cases. To conduct such evaluation requires an in-depth understanding of the level of the leachables and the property of the drug product itself. This presentation will share several potential causes that why leachables can affect the impurity profile of the drug products. And several case studies will be presented.
Q. What are you most looking forward to at the conference of E&L China?
Global Regulatory Landscape and Updates on E&L.