Ahead of the upcoming Extractables & Leachables China 2020 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 in Pharmaceutical Packaging and Drug Dlivery Systems' 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?
The key concern is if the risk substances from materials and packages can be completely identified, and if safety issues will be generated due to intake unrecognized risk substances.
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?
The leachable study for disposable infusion apparatus and eyedrops is just initiated in China, and it is necessary to pay more attention and cost more time to think about it for both regulatory agencies and pharmaceutical enterprises.
Shanghai WEIPU Chemical Technology Service Co., Ltd. will seak the best solutions for these marketing needs together with Packaging Materials Association and other capable enterprises.
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?
The hottest topic is that how to study the leachables scientifically. Currently, the study strategy is matured and significantly sufficient, however, the strategy sometimes is not considered with the drug properties and usage. For example, different solvents with different PH are all applied for one drug E&L study, but the drug itself maybe only used in neutral aqueous solution. The E&L study strategy should be back for drug self to ensure the product quality and patient safety.
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?
We plan to build a leachable analytical service platform for food, cosmetics and pharmaceutical industry.
Q. What do you expect the future regulatory landscape of Extractables and Leachables in China is going to be?
We believe that regulators prefer to use QbD concept to the review the compatibility study reports.
Q. Your presentation at this year’s E&L China will cover Challenges of E&L study on chemical drugs (parenteral) and drug delivery systems. Why is it important for others in your industry to hear this message? What are some of the key take-aways?
Drug delivery devices are not the same as ordinary packaging materials. Regardless of the differences in materials selection, production technology and quality control, the research ideas related to packaging materials are not sufficient and scientific for the evaluation of drug delivery devices. Therefore, on the matter of drug delivery devices, pharmaceutical companies, device manufacturers, regulatory agencies, and service organizations need to work things out together.