Ahead of the upcoming Extractables & Leachables China 2020 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 'Insights and Perspectives from Pharma and Biotech Companies' session.
Current Industry Focus:
Q. As consumers/end users continually push for more safer solutions, what do you think is the biggest concern regarding Extractables and Leachables?
How to properly design experiments to perform method evaluation and qualification for unknown extractables screening.
Q. What are some of the biggest opportunities gaining attention within the Extractables and Leachables field? How has your company chosen to react/adapt to stay on trend?
E/L risk assessment regarding plastic components and systems used in pharmaceutical drug products manufacturing. Our company has developed an internal workflow for such risk assessment referring USP PF665/1665.
Q. What industry topics are getting the most attention at this time? How are these factors influencing the future of pharmaceutical packaging/medical device materials?
Nitrosamines and nitrosatable substances in pharmaceutical packaging materials (e.g. elastomers). As nitrosamine impurities in API/ drug products getting more and more attention over the past one year, pharmaceutical packaging systems will be subjected to comprehensive assessment. Pharmaceutical companies will need to use cleaner packaging materials, understand the formation mechanism of nitrosamine impurities and develop detection methods with adequate sensitivity and specificity. The same changes will happen to the manufacturers of packaging material side.
Q. What does your company/organization hope to achieve over the next 5 years with regards to the future of pharmaceutical (packaging)/medical device industry?
Our company plan to optimize the workflow of E/L evaluation for pharmaceutical (packaging)/medical devices. Based on the evaluation results, experiments at different extent will be performed to mitigate risk(s).
Q. What opportunities are there for harmonization of pharmaceutical packaging/medical devices in the Asia Pacific region?
The implementation of ICH Q3E.
Q. What do you expect the future regulatory landscape of Extractables and Leachables in China is going to be?
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 this year’s E&L China will cover How to Properly Design and Execute E/L studies for Drug Delivery Systems of Parenteral Drug Products - from the Perspective of a Drug Products Manufacturer. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
Pharmaceutical companies are sometimes required to perform compatibility studies regarding parenteral drug products and their drug delivery systems while submitting drug applications. However, in most circumstances, for drug products manufacturers that do not produce drug delivery systems (e.g. base IV or infusion devices), it is difficult to control which brand/material of drug delivery systems the hospitals use. Therefore, it is important to properly design the compatibility test with limited lab resources. This presentation will illustrate general considerations for the design of E/L studies of drug delivery systems. And from the perspective of a pharmaceutical company, we will discuss whether it is always necessary to carry out extractable profiling experiments by presenting several case studies.
Q. Which presentations (what session topic) are you most looking forward to hearing about at E&L China?
Global Regulatory Landscape And Updates on E&L