Q: You used to work as Principal Scientist at Johnson and Johnson, to what degree does your role differ at Intertek, and what past experience are you benefitting from in this role?
My role is quite different since I have lot of daily interaction with clients. At J&J our major focus was on medical devices, in my new role we need to provide support for medical devices, food and the classical pharma sector.
Q: At the conference you are speaking on Leachable testing for large volume parenteral products. Why do large volume parenteral pharmaceuticals represent one of the highest risk drug products in relation to the potential introduction of impurities via container closure contact?
In my opinion the large volume parenteral products represent a relatively high risk since they are directly entering the blood stream and reaching multiple organs. The analytical testing of those products are challenging since the formulations are mainly aqueous based and due to the large volume the target analytes are at a very low concentration level.
Q: Back in 2013 we asked you which area of E&Ls do you currently deem most important and why? You answered as follows:
A in 2013: In my opinion, one of the most important aspects is to have a regulatory guidance developed to harmonize analytical requirements for leachables and extractables and other low level components in the pharmaceutical and medical devices. Also, I think it would be helpful to have agreement on how to assess toxicity and correlate toxicity data for implantable medical devices, since the extractables and leachables route of administration is usually different than oral and inhalation products.
Would your answer be different today?
I would not answer differently today. Those challenges still exist. One of the next steps for the USP is to publish a chapter for medical device testing.
Q: There is also increased interest in E&L testing for e-cigarettes, to what degree could E&Ls pose a health risk in these devices?
In my opinion the risk is similar to inhalation products. You have a plastic delivery unit (device), which delivers an active pharmaceutical product (nicotine) and a couple of excipients via inhalation. The aerosol producing mechanism is fairly involved, therefore the risk of leaching could be relatively high.
Q: What are you looking forward to about joining us at E&L USA? Why is this event one that you regularly look to support?
I am attending this meeting for a 4th consecutive year. I always enjoy the conversations and the scientific debates. As Daniel Norwood (Boehringer Ingelheim) stated last year the scientific quality of the presentations are improving year by year. I am looking forward to be there again in May and presenting as speaker.
Gyorgy Vas, has a M Sc Analytical Chemistry and a Ph. D. in Mass Spectrometry. He has published 16 research papers, which have been cited more than 750 times. Now Research Fellow at Intertek, Gyorgy previously worked for Johnson & Johnson for 6 years and is an expert in trace level analytical method development and method validation.
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