Q. What are the biggest challenges facing the E&L sector (in China)?
Ahead of the upcoming Extractables & Leachables China 2021 conference, we caught up with Cuicui Zhu, Validation Center Manager at Hangzhou Cobetter. She gave us a sneak peek of what we can expect from her presentation on day one, taking place during our 'E&L Study on Single Use Systems' session.
I think qualitative research and safety assessment of E&L are the biggest challenges. As we know, when we do E&L studies, sometimes there will be many unknowns, especially when E&L studies are carried out under some worse conditions. And it is difficult to accurately characterize these unknowns. At the same time, the safety assessment of both known and unknown E&L is very important and requires professional toxicologists to carry out, and China is short of professional toxicologists.
Q. What are the biggest priorities for medical device and pharmaceutical companies when it comes to E&L studies?
The safety of E&L or the safety of material is their biggest priority. Because the safety of E&L is related to the life and health of patients.
Q. What technical issues to you think still need to be addressed in the future?
Standardize and refine E&L analytical methods, provide toxicological data for common E&L (e.g., PDE).
Q. How do you think the future regulatory landscape will impact E&L studies in China?
Future regulations will have higher requirements, and more regulations or guidelines will be issued to regulate or guide us to conduct E&L studies. I believe that E&L studies in China will become more and more perfect and scientific.
Q. What opportunities are there for harmonization of pharmaceutical packaging/ single use systems/ medical devices in China and the rest of the Asia Pacific region?
As mentioned above, we need more standardized and detailed E&L analytical methods, and we also need common E&L toxicological data for reference. In China, many drug manufacturers do not know how to use the E&L data provided by component/packaging manufacturers, and they entrust a third party or component/packaging manufacturer to conduct E&L studies. I think this is also an opportunity, and it is necessary to issue more guiding guidelines for drug manufacturers' reference.
Q. Your presentation at E&L China this year is titled “E&L Study for Single-use Systems Based on Risk Assessment”. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
The content of the topic is combined with domestic and foreign regulations and guidelines, and E&L study process and key points for SUS will be introduced in detail, which has very important guiding significance in E&L studies. At the same time, I will introduce how to use the E&L data provided by suppliers to solve the pain points of pharmaceutical companies.
Q. What are you most looking forward to at the conference of E&L China?
Discuss E&L study issues with top E&L experts in the industry.