Ahead of this year's Extractables & Leachables Europe 2017, we spoke to Greg Erexson, Senior Principal Research Scientist at AbbVie, about the challenges of permitted daily exposure (PDE) values for extractables, ELSIE, potential for knowledge growth and much more.
1. Your presentation will look at the challenges of permitted daily exposure (PDE) values for extractables, what does this mean and what will it cover?
Establishing safe daily exposure limits (or permitted daily exposures, PDEs) for extractables and leachables (E&L) are challenging when there is little or no toxicity data available for the defined E&L compound. PDE values are needed for each compound or compound class to assess patient risk as the E&L compounds are not efficacious to the patient and must be controlled to the lowest/safest amount possible. My presentation will discuss strategic methods for deriving PDE values from challenging compounds to assess patient risk from potential exposure to E&L compounds.
2. Your presentation will cover the work of ELSIE, would you be able to share what ELSIE is and why it is an integral part of the E&L community?
Briefly, the ELSIE consortium started in 2007. ELSIE is the Extractables and Leachables Safety Information Exchange. ELSIE's core objective has been to establish a comprehensive database that provides a jointly-developed and credible source of (i) safety information on extractables and leachables and (ii) extraction profiles and standardised study protocols for a range of materials commonly used in pharmaceutical, biological and device applications and processes (e.g., container closure systems, devices, manufacturing/processing).
3. Where do you see the potential for knowledge growth in the industry in the next 5 years and why?
In the next 5 years, as in the past decade or so, I expect the E&L industry (especially for medical devices and combination products) to continue growing at a steady pace. More companies are entering this business and expanding on their chemistry and toxicology infrastructure to help support the growing demands in this industry.
4. What are you most looking forward to at E&L Europe 2017?
Networking with other scientists and learning processes for dealing with E&L current issues and focus in the industry.
Greg will be presenting as part of the 'Case Studies' session this November. Other speakers in the session include Toxikon, Baxter, Anatune and GlaxoSmithKline.
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