Current Industry Focus:
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 Xiaojun Yang, Technical Director of Biomedical Technology Center at Shanghai WEIPU. He gave us a sneak peek of what we can expect from his presentation on day one, taking place during our 'E&L Study on Pharma Packaging' session.
The biggest challenge is whether the risk substances from materials and packages can be effectively identified, and whether hidden safety hazards exist due to the intake, sometimes inevitably, of unrecognized risk substances.
Q. What are the biggest priorities for medical device and pharmaceutical companies when it comes to E&L studies?
With the spread of clinical orientation and patient-first values, the entire pharmaceutical industry is pushing for more user-friendly solutions that aims to reduce harm and enhance the experience feeling during treatment. E&L study aims at providing wisdom and strength for the safety and convenience of drug delivery.
Q. What technical issues to you think still need to be addressed in the future?
In the field of E&L stay, there will be increasing requirements for data integrity, authenticity and traceability, and more emphasis on designing of extraction solution, AET calculation, unknown substance resolution, and methodological validation.
Q. How do you think the future regulatory landscape will impact E&L studies in China?
With the improvement of regulations and guidelines, regulators have higher requirement on logical, scientific, and reasonable E&L study. Under the effective guidance of regulators, E&L study will focus on QbD (Quality by Design) and scientific development.
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?
With the harmonious development in E&L realm, it's necessary to implement more optimal and reasonable scientific research. Currently research ideas in the industry are becoming more common and detailed, but most of them are not combined with the characteristics in drugs. E&L study should focus on the steady quality of drug and patient safety, and use scientific and reasonable methods to avoid wasting resources.
Q. Your presentation at E&L China this year is titled“Technical points of compatibility study of oral preparations”. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
Oral preparations are low-risk dosage forms, but improper packaging materials or ink labels are used, there is still a risk of compatibility. Mr. Yang will start from the existing regulatory requirements, introduces the technical difficulties encountered in the compatibility study of oral preparations and the corresponding solutions, and help enterprises how to scientifically and reasonably evaluate whether the compatibility between packaging materials and oral preparations is safe.
Q. What are you most looking forward to at the conference of E&L China?
The ultimate goal of E&L study is clinical application and client-centered therapy, which requires the joint efforts of the whole industry. We expect that key decision makers and stakeholders could take this opportunity to discuss E&L safety and solutions from both the pharmaceutical and medical device perspectives in E&L China 2021.