View the On-Demand content from our live virtual conference that took place on September 9th, 2020. Global industry and regulatory experts discussed current E&L hot topics on pharmaceuticals, biopharmaceuticals and medical devices. Extractables and leachables are an important area in medical device and medicinal products, especially in this COVID-19 world. In addition there is urgent testing requirements for new ventilators and for delivery devices for vaccines. This On-Demand content will give you an insight to this ever-changing world of E&L.
“Extractable and leachable study design: Optimizing success for identification and quantification”
Dr. Andrew Feilden is the European E&L Strategic Director at Hall Analytical. He joined Hall in November 2019 where he is a technical expert in the field of E&L testing undertaking commercial, operational and technical thought leadership activities. He has presented on the field of extractables and leachables in over 16 countries world wide. Andrew has written a number of papers and publications and is the inventor of 2 patents. He has a degree and D Phil from the University of York, is a Fellow of the Royal Society of Chemistry and was a Scientific advisor to IPAC-RS and ex-cochair of ELSIE.
“The Need to Identify Unknown E&L Compounds from a Toxicological Perspective”
Ron Brown is a toxicologist with 35 years of experience in regulatory toxicology and risk assessment. He recently retired from the US FDA after 25 years of service and currently directs a small company, Risk Science Consortium, LLC, that provides consultation and training in toxicological risk assessment and computational toxicology. At the FDA, Ron was the senior toxicologist responsible for developing and reviewing toxicological risk assessments of extractable and leachable (E&L) compounds from medical devices.
“How to evaluate different classes of chemicals detected from extractables and leachables analyses”
Charles is a graduate chemist who has been part of the team of toxicologists at bibra for 5 years. A significant proportion of his time involves the toxicological assessment of extractables and leachables derived from various products including medical devices, pharmaceutical packaging and e-cigarette products on a daily basis.
“The Use of Analytical Chemistry in Medical Device Safety Assessments”
Philip Clay is Director and principal toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specializes in safety assessment with over 30 years experience. He has published and presented widely in his expert field of genetic toxicology and also in the wider area of safety assessment. Chorley Consulting designs safety assessment programs for medical devices and also provides toxicological advice for a range of product types. Philip is presently a BSI committee member for CH/194 (Biological evaluation of medical devices).
“Challenging the Status Quo ‘Is the E&L Community Ready to Move Away from Conventional Large Volume Liquid/Liquid Extraction and Solvent Evaporation?”
An analytical scientist by training, Mike graduated from the University of Nottingham with a PhD in flavour and aroma science in 2004. Over the past 17 years, Mike has held roles of increasing responsibility within GSK, Pfizer and most recently Baxter, where he has been accountable for defining and executing the regulatory strategy that mitigates the risk of patient exposure to leachables for a variety of product types including inhalation (DPIs and MDIs), parenteral (LVP, PFS and lyophilised formulations), biopharmaceutical (manufacturing processes, primary container closure and administration) and most recently cell & gene therapy products.
“Risk of interaction between extractables and leachables (E&L) and therapeutic proteins/peptides – Case Studies”
Andrew Teasdale PhD has over 25 years’ experience in the pharmaceutical industry as an analytical chemist and within quality assurance and regulatory roles. In his current role he chairs AstraZeneca’s Impurity Advisory Group. Dr Teasdale has published a number of papers relating to extractables and leachables, mutagenic impurities and other impurity related matters. He is currently the chair of the Extractables and Leachables safety Information exchange (ELSIE) and also led a number of industry expert groups; these include both safety and quality groups within Pharmaceutical Research and Manufacturers of America (PhRMA), European Federation of Pharmaceutical Industries and Associations (EFPIA), Product Quality Research Institute (PQRI) .