Q. What are the biggest challenges facing the E&L sector (in China)?
Yi Zhang, Laboratory Director from Bruns Lab will be presenting at this month's Extractables & Leachables China 2021, discussing E&L Testing and Assessments for Transdermal Patches.
Read on to hear her thoughts on the biggest priorities for medical device and pharmaceutical companies and how the future regulatory landscape will impact E&L studies in China.
Take a look below now to find out what was said...
The biggest challenge comes from how to identify the risk substances from drug manufacture process and packaging materials in complex matrix, so as to avoid human omission or neglect of potential risk substances.
Q. What are the biggest priorities for medical device and pharmaceutical companies when it comes to E&L studies?
Priority should be the possible risks to the drug product caused by the materials or components. By designing various technical means, including appropriate E&L studies, the purpose is to minimize the risk to patients.
Q. What technical issues to you think still need to be addressed in the future?
Compatibility studies should not be templated, which will lead to the same target of concern for components/ materials from all sources. E & L study is designed based on the actual application of drugs and the properties of materials, for example, appropriate extraction technology, optimized pretreatment method and full scanning method.
Q. How do you think the future regulatory landscape will impact E&L studies in China?
With the increasing attention to E & L, more comprehensive and detailed regulations and executive standards will be issued in the future, which will guide the E & L study to be scientific, standardized and systematic. The increasingly strict regulatory environment would promote enterprises to take compatibility research as an important part in product development procedure, and to design reasonable E & L study to control the quality of components and packaging materials.
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?
At present, although the technical skill has been improved, there are still uneven. The harmonization of pharmaceutical packaging/ single use systems/medical devices is conducive to the development of the whole industry. The consensus of the industry and experts is conducive to the elimination of barriers to product R & D and fasten the development of new product.
Q. Your presentation at E&L China this year is titled “Extractables and Leachables Testing and Assessments for Transdermal Patches”. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
"Technical Guidelines for Pharmaceutical Research on Transdermal Patches of Chemical Generic Drugs (Trial)" is formulated by the Center for Drug Evaluation of China National Medical Products Administration in 2020, which requiring the E&L evaluation. At present, the compatibility study for patch in China is still in its infancy. In this meeting, I will mainly share the experience and strategies of compatibility study of transdermal patches，and introduced how to evaluate the leachables regards the regulatory requirements.
Q. What are you most looking forward to at the conference of E&L China?
We are expecting more experts involve in this E & l China annual meeting, including component / packaging material manufacturers, pharmaceutical enterprise researchers, regulatory experts and experimental researchers, and share their experiences.