Ahead of the upcoming E&L Europe 2019 conference in London, we caught up with Ping Wang, Scientific Director at Janssen Research & Development, to get his insights into extractable data mining, challenges faced by the industry, future opportunities for the industry and much more.
Your presentation will discuss “Extractable data mining: common extractables from polymeric manufacturing materials used in biologics production “ can you give us a sneak peak of what delegates will hear?
I will present some details of the extractable data we acquired over the past few years for all major polymeric materials used for SUS. Hopefully, those extractable data will give audiences some ideas what kind of extractables will be commonly observed from those materials. Some interesting and useful conclusion can be drawn from the list of those compounds.
Why did you choose to tackle this topic?
Lot of discussions were made in the past few years on the safety concerns of the extractables and leachables. Often, E&L were treated as much worse impurities that other regular impurities from API. The safety concern thresholds were often set lower than that from ICH Q3A, Q3B and Q3C. Often the fear comes from lack of true understanding of the nature of E&L. Hopefully, our work thru the data mining can shed more light on the nature of common E&L compounds so proper safety concern thresholds of E&L can be established.
What are the main challenges in your day-to-day work relating to extractable data mining?
Obtaining more data on more materials is time consuming and costly. It takes dedication from both the company and the suppliers.
Where is the extractable and leachable field headed in coming years and what’s revolutionising extractable and leachable research?
Hopefully, through more work and studies of end users and suppliers, better understanding of the polymeric materials can be achieved. Long term goal is to have suppliers to provide comprehensive materials composition and impurity information, and end users won’t need to perform regular extractable studies of those materials. Also, more proof that further purification process can effectively eliminate majority of E&L before they reach to final container closure system of drug products.
What are the major challenges that the extractable and leachable industry is facing?
The cost of doing testing, and ever challenging regulatory requirements are the major challenges end users, suppliers and testing labs have to face.
What are you most looking forward to hearing about at E&L Europe 2019?
I am looking forward to meet new people and exchange ideas discuss challenges with delegates.
What is one thing you hope to learn or discuss with your peers at this E&L conference?
Any regulatory trend regarding E&L concerns from EU or other regions.
Why do you feel it’s important for companies to attend E&L Europe 2019?
This is one important venue for suppliers, end users and contract labs to have the most updated information, from study approaches, regulatory directions, new testing technologies, and any interesting finds in the polymeric materials.
Ping will be presenting as part of the 'Effects of E&Ls on the safety and efficacy of proteins, biopharmaceuticals and cell-based therapies' alongside speakers from AstraZeneca, Hall Analytical and more.
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